Viewing Study NCT06860594


Ignite Creation Date: 2025-12-25 @ 1:40 AM
Ignite Modification Date: 2025-12-25 @ 11:56 PM
Study NCT ID: NCT06860594
Status: RECRUITING
Last Update Posted: 2025-12-24
First Post: 2025-03-05
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma
Sponsor:
Organization:

Raw JSON

{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'C078157', 'term': '3-aminopyridine-2-carboxaldehyde thiosemicarbazone'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-03-05', 'studyFirstSubmitQcDate': '2025-03-05', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of dose-limiting toxicity', 'timeFrame': 'Up to 28 days', 'description': 'Will be graded in severity according to the Common Terminology Criteria for Adverse Events version 5.0. Frequency and severity of adverse events and tolerability of the regimen will be collected and summarized with descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient and frequency tables will be reviewed to determine toxicity patterns. Will employ the Backfill Bayesian Optimal Interval design to guide dose escalation and establish the maximal tolerated dose (MTD). The target toxicity rate for the MTD is = 0.25.'}], 'secondaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'Up to 5 years', 'description': 'Response rate will be categorized based on the Response Assessment in Neuro-Oncology criteria, in which tumor response is based on clinical history, physical exam, and imaging findings. The total number of patients in each response category divided by the total number of evaluable patients determines response rate. An evaluable patient is defined as an eligible patient who received at least one dose of triapine. The response rates will be calculated with corresponding 95% exact Clopper-Pearson confidence intervals.'}, {'measure': 'Plasma pharmacokinetic (PK) parameters', 'timeFrame': 'Up to 2 weeks', 'description': 'Triapine in plasma and peri-tumoral dialysate will be quantified using a validated liquid chromatography-tandem mass spectrometry assay. Plasma PK parameters will be derived and compared to historical controls. Dialysate concentrations will be calculated at multiple time points. Exploratorily, exposure-response relationships will be evaluated.'}, {'measure': 'Progression-free survival', 'timeFrame': 'From study enrollment to date of either disease progression or death, assessed up to 5 years', 'description': 'Will be estimated using Kaplan Meier curves.'}, {'measure': 'Overall survival', 'timeFrame': 'From study enrollment to date of death, assessed up to 5 years', 'description': 'Will be estimated using Kaplan Meier curves.'}, {'measure': 'Proportion of patients who initiated bevacizumab for symptom control', 'timeFrame': 'Up to 5 years', 'description': 'Will be calculated using descriptive statistics.'}, {'measure': 'Tumor tissue biomarkers', 'timeFrame': 'Up to 5 years', 'description': 'The presence of genetic alterations, expression of RRM2, and other molecular gene expression signatures will be descriptive in relation to tumor response and clinical outcomes.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Astrocytoma, IDH-Mutant, Grade 2', 'Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant', 'Recurrent Adult Diffuse Midline Glioma, H3 K27-Mutant', 'Recurrent Astrocytoma, IDH-Mutant', 'Recurrent Astrocytoma, IDH-Mutant, Grade 3', 'Recurrent Astrocytoma, IDH-Mutant, Grade 4', 'Recurrent Glioblastoma, IDH-Wildtype']}, 'descriptionModule': {'briefSummary': 'This phase I trial tests the safety, side effects, and best dose of triapine in combination with radiation therapy in treating patients with glioblastoma or astrocytoma that has come back after a period of improvement (recurrent). Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving triapine in combination with radiation therapy may be safe, tolerable, and/or effective in treating patients with recurrent glioblastoma or astrocytoma.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To identify the safety and maximally tolerated dose (MTD) of oral triapine used in combination with radiation therapy for patients with recurrent glioblastoma (GBM) or astrocytoma.\n\nSECONDARY OBJECTIVES:\n\nI. To observe and record anti-tumor activity. II. To determine the pharmacokinetics of oral triapine in plasma and the central nervous system (CNS).\n\nIII. To evaluate the efficacy of triapine when administered in combination with radiation therapy by assessing:\n\nIIIa. Progression-free survival (PFS); IIIb. Overall survival (OS); IIIc. The proportion of patients requiring bevacizumab for symptom control; IIId. The correlation of genetic mutations in select genes (e.g., p53, p16, KRAS, and Pi3k/mTOR/AKT) with tumor response and clinical outcomes.\n\nOUTLINE: This is a dose-escalation study of triapine in combination with radiation therapy.\n\nPatients undergo intensity-modulated radiation therapy (IMRT) once daily (QD) 5 days per week (Monday-Friday) for a total of 10 treatment days over 2 weeks and receive triapine orally (PO) 2 hours prior to IMRT on each radiation treatment day in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) and/or magnetic resonance imaging (MRI) throughout the study as well as blood sample collection during screening and on study. Patients may undergo cerebrospinal fluid (CSF) sample collection during screening.\n\nAfter completion of study treatment, patients are followed up at 2 weeks after radiation therapy, then every 3 months for up to 5 years from study treatment initiation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have histologically, molecularly, or cytologically confirmed recurrent astrocytic tumors including:\n\n * GBM or variants, IDH-wildtype, grade 2-4 (standard curative measures available or not)\n * Astrocytoma, IDH-mutant, grade 2-4 (standard curative measures available or not)\n * Diffuse midline gliomas, including pediatric-type H3 G34 or E3 K27 mutant tumors.\n* Tumors ≤ 6 cm in maximal diameter.\n\n * Patients who had recent resection for recurrent tumor must have measurable disease.\n* Patients must have at least a 6-month break from last dose of radiation therapy.\n\nRe-irradiation within 6 months may increase risk for radiation necrosis/edema, which will affect toxicity assessment and patient safety. Additionally, GBM and other high-grade astrocytic tumors can exhibit pseudo-progression within 6 months from completing definitive, 1st line radiation therapy, and re-irradiation during this period will increase risk for misattribution of effect.\n\n* Prior history of standard dose radiation for gliomas of 59.4-60 gray (Gy) in 1.8-2 Gy per fraction (or equivalent or lower) is allowed.\n* Patients who received non-standard radiation dose regimen (e.g., 40 Gy, 34-35 Gy, 25 Gy) or stereotactic radiosurgery are eligible as long as there is at least one of the following:\n\n * A new tumor outside the original radiotherapy field as determined by the investigator.\n * There is histologic confirmation of tumor on biopsy or resection.\n * Imaging findings are consistent with true progressive disease (on standard MRI sequences, MRI spectroscopy/perfusion, or nuclear medicine imaging).\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of triapine in patients \\< 18 years of age, children are excluded from this study.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%).\n* Absolute neutrophil count ≥ 1,500/mcL.\n* Hemoglobin ≥ 8 g/dL.\n* Platelets ≥ 100,000/mcL.\n* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN).\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 x institutional ULN.\n* Creatinine ≤ 1.5 x ULN OR glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m\\^2.\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n* Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class II or better.\n* Patients must be able to swallow whole capsules.\n* Patients must be able to undergo MRIs with contrast. Patients with non-compatible devices with MRI can be eligible if CT scans of sufficient quality are obtained. However, patients without non-compatible devices may not use CT scans to meet this requirement.\n* The effects of triapine on the developing human fetus are unknown. For this reason and because ribonucleotide reductase (RNR) inhibitor agent and radiation are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 12 months after finishing study treatment. People of child-bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 2 weeks of registration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 12 months after completion of triapine administration.\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.\n\nExclusion Criteria:\n\n* Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia.\n* Patients who are receiving any other investigational agents.\n* Patients who are actively taking medications that are known to induce methemoglobinemia (e.g. sulfonamides, nitrofurans, anti-malarials \\[primaquine, chloroquine\\], cyclophosphamide, and ifosfamide).\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to triapine.\n* Patients with known G6PD deficiency. Testing for G6PD deficiency is not required.\n* Patients with uncontrolled intercurrent illness, active infections, or any other significant condition(s) that would make participation in this protocol unreasonably hazardous.\n* Pregnant women are excluded from this study because triapine is a RNR inhibitor agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with triapine, breastfeeding should be discontinued if the mother is treated with triapine. These potential risks may also apply to the radiation used in this study.'}, 'identificationModule': {'nctId': 'NCT06860594', 'briefTitle': 'Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I Trial Combining Triapine With Radiation Therapy for Recurrent Glioblastoma or Astrocytoma', 'orgStudyIdInfo': {'id': 'NCI-2025-01531'}, 'secondaryIdInfos': [{'id': 'NCI-2025-01531', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'PHI-151'}, {'id': '10699', 'type': 'OTHER', 'domain': 'City of Hope Comprehensive Cancer Center LAO'}, {'id': '10699', 'type': 'OTHER', 'domain': 'CTEP'}, {'id': 'UM1CA186717', 'link': 'https://reporter.nih.gov/quickSearch/UM1CA186717', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (IMRT, triapine)', 'description': 'Patients undergo IMRT QD 5 days per week (Monday-Friday) for a total of 10 treatment days over 2 weeks and receive triapine PO 2 hours prior to IMRT on each radiation treatment day in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or MRI throughout the study as well as blood sample collection during screening and on study. Patients may undergo CSF sample collection during screening.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Procedure: Computed Tomography', 'Radiation: Intensity-Modulated Radiation Therapy', 'Procedure: Magnetic Resonance Imaging', 'Drug: Triapine']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo blood and CSF sample collection', 'armGroupLabels': ['Treatment (IMRT, triapine)']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'Computerized Axial Tomography', 'Computerized axial tomography (procedure)', 'Computerized Tomography', 'Computerized Tomography (CT) scan', 'CT', 'CT Scan', 'Diagnostic CAT Scan', 'Diagnostic CAT Scan Service Type', 'tomography'], 'description': 'Undergo CT', 'armGroupLabels': ['Treatment (IMRT, triapine)']}, {'name': 'Intensity-Modulated Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['IMRT', 'Intensity modulated radiation therapy (procedure)', 'Intensity Modulated RT', 'Intensity-Modulated Radiotherapy', 'Radiation, Intensity-Modulated Radiotherapy'], 'description': 'Undergo IMRT', 'armGroupLabels': ['Treatment (IMRT, triapine)']}, {'name': 'Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'otherNames': ['Magnetic Resonance', 'Magnetic Resonance Imaging (MRI)', 'Magnetic resonance imaging (procedure)', 'Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MR', 'MR Imaging', 'MRI', 'MRI Scan', 'MRIs', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging', 'sMRI', 'Structural MRI'], 'description': 'Undergo MRI', 'armGroupLabels': ['Treatment (IMRT, triapine)']}, {'name': 'Triapine', 'type': 'DRUG', 'otherNames': ['3-aminopyridine-2-carboxaldehyde thiosemicarbazone', '3-AP', '3-Apct', 'OCX-0191', 'OCX-191', 'OCX191', 'PAN-811'], 'description': 'Given PO', 'armGroupLabels': ['Treatment (IMRT, triapine)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'becomingapatient@coh.org', 'phone': '800-826-4673'}, {'name': 'Stephanie M. Yoon', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'City of Hope Comprehensive Cancer Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92612', 'city': 'Irvine', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'ucstudy@uci.edu', 'phone': '877-827-8839'}, {'name': 'Jerica M. Lomax', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'cancercto@ucsd.edu', 'phone': '858-822-5354'}, {'name': 'David E. Piccioni', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UC San Diego Moores Cancer Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'ucstudy@uci.edu', 'phone': '877-827-8839'}, {'name': 'Jerica M. Lomax', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UC Irvine Health/Chao Family Comprehensive Cancer Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '916-734-3089'}, {'name': 'Orwa Aboud', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California Davis Comprehensive Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'canceranswers@yale.edu', 'phone': '203-785-5702'}, {'name': 'Nicholas A. Blondin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06611', 'city': 'Trumbull', 'state': 'Connecticut', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'canceranswers@yale.edu', 'phone': '203-785-5702'}, {'name': 'Nicholas A. Blondin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Smilow Cancer Hospital Care Center-Trumbull', 'geoPoint': {'lat': 41.24287, 'lon': -73.20067}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '202-444-2223'}, {'name': 'Edina Komlodi-Pasztor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MedStar Georgetown University Hospital', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '404-778-1868'}, {'name': 'Kimberly Hoang', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Emory University Hospital/Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'cancer@northwestern.edu', 'phone': '312-695-1301'}, {'name': 'Karan Dixit', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '62269', 'city': 'Shiloh', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'dschwab@wustl.edu', 'phone': '314-747-9912'}, {'name': 'Tanner M. Johanns', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Memorial Hospital East', 'geoPoint': {'lat': 38.56144, 'lon': -89.89732}}, {'zip': '66205', 'city': 'Fairway', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'KUCC_Navigation@kumc.edu', 'phone': '913-588-3671'}, {'name': 'Tolga Tuncer', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kansas Clinical Research Center', 'geoPoint': {'lat': 39.02223, 'lon': -94.6319}}, {'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'KUCC_Navigation@kumc.edu', 'phone': '913-588-3671'}, {'name': 'Tolga Tuncer', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kansas Cancer Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '66205', 'city': 'Westwood', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'KUCC_Navigation@kumc.edu', 'phone': '913-588-3671'}, {'name': 'Tolga Tuncer', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kansas Hospital-Westwood Cancer Center', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '859-257-3379'}, {'name': 'John L. Villano', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kentucky/Markey Cancer Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '63376', 'city': 'City of Saint Peters', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'info@siteman.wustl.edu', 'phone': '800-600-3606'}, {'name': 'Tanner M. Johanns', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Siteman Cancer Center at Saint Peters Hospital', 'geoPoint': {'lat': 38.80033, 'lon': -90.62651}}, {'zip': '63141', 'city': 'Creve Coeur', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'info@siteman.wustl.edu', 'phone': '800-600-3606'}, {'name': 'Tanner M. Johanns', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Siteman Cancer Center at West County Hospital', 'geoPoint': {'lat': 38.66089, 'lon': -90.42262}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'info@siteman.wustl.edu', 'phone': '800-600-3606'}, {'name': 'Tanner M. Johanns', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63129', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'info@siteman.wustl.edu', 'phone': '800-600-3606'}, {'name': 'Tanner M. Johanns', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Siteman Cancer Center-South County', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63136', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'info@siteman.wustl.edu', 'phone': '800-600-3606'}, {'name': 'Tanner M. Johanns', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Siteman Cancer Center at Christian Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'cancerclinicaltrials@cumc.columbia.edu', 'phone': '212-342-5162'}, {'name': 'Aya Haggiagi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '800-804-9376'}, {'name': 'Ashley L. Sumrall', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Carolinas Medical Center/Levine Cancer Institute', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'ou-clinical-trials@ouhsc.edu', 'phone': '405-271-8777'}, {'name': 'James D. Battiste', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Oklahoma Health Sciences Center', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '15232', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '412-647-8073'}, {'name': 'Megan Mantica', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pittsburgh Cancer Institute (UPCI)', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'phone': '800-811-8480'}, {'name': 'Alexander C. Mohler', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Vanderbilt University/Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'cancerinfo@hci.utah.edu', 'phone': '888-424-2100'}, {'name': 'Joe S. Mendez', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Huntsman Cancer Institute/University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'CTOclinops@vcu.edu', 'phone': '804-628-6430'}, {'name': 'Mariza Daras', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'VCU Massey Comprehensive Cancer Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '53718', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'clinicaltrials@cancer.wisc.edu', 'phone': '800-622-8922'}, {'name': 'Brett A. Morris', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Wisconsin Carbone Cancer Center - Eastpark Medical Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Site Public Contact', 'role': 'CONTACT', 'email': 'clinicaltrials@cancer.wisc.edu', 'phone': '800-622-8922'}, {'name': 'Brett A. Morris', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Wisconsin Carbone Cancer Center - University Hospital', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Stephanie M Yoon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Comprehensive Cancer Center LAO'}]}, 'ipdSharingStatementModule': {'url': 'https://grants.nih.gov/policy/sharing.htm', 'ipdSharing': 'YES', 'description': 'NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}