Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT00276835
Status:
COMPLETED
Last Update Posted:
2015-04-10
First Post:
2006-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genistein and Interleukin-2 in Treating Patients With Metastatic Melanoma or Kidney Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D008545', 'term': 'Melanoma'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}], 'ancestors': [{'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D018326', 'term': 'Nevi and Melanomas'}, {'id': 'D012878', 'term': 'Skin Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007376', 'term': 'Interleukin-2'}, {'id': 'C082598', 'term': 'aldesleukin'}, {'id': 'D019833', 'term': 'Genistein'}, {'id': 'D007529', 'term': 'Isoflavones'}], 'ancestors': [{'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-08', 'studyFirstSubmitDate': '2006-01-12', 'studyFirstSubmitQcDate': '2006-01-12', 'lastUpdatePostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Differences in peak and duration of the expansion of circulating CD4+, CD8+, and CD4+, CD25+, and CD56+ cells (dim and bright)', 'timeFrame': 'Days 1, 8, 10, 15, 22, and 24 of treatment'}], 'secondaryOutcomes': [{'measure': 'Circulating plasma levels of TGF-beta', 'timeFrame': 'Prior to and at end of treatment'}]}, 'conditionsModule': {'keywords': ['recurrent renal cell cancer', 'clear cell renal cell carcinoma', 'stage IV renal cell cancer', 'recurrent melanoma', 'stage IV melanoma'], 'conditions': ['Kidney Cancer', 'Melanoma (Skin)']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Genistein may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Interleukin-2 may stimulate the white blood cells, including natural killer cells, to kill melanoma or kidney cancer cells. Giving genistein together with interleukin-2 may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well giving genistein together with interleukin-2 works in treating patients with metastatic melanoma or kidney cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Measure the differences in peak and duration of the expansion of circulating CD4-positive, CD8-positive, and CD4-, CD25-, and CD56-positive cells (dim and bright) at different time points during therapy with interleukin-2 (IL-2) alone and plus genistein in patients with metastatic malignant melanoma or renal clear cell carcinoma.\n\nSecondary\n\n* Evaluate the differences in peripheral blood mononuclear cell gene expression following high-dose IL-2 with and without genistein and compare to baseline.\n* Determine the overall response rate (partial and complete) in patients treated with these regimens.\n* Determine the safety and toxic effects of these regimens in these patients.\n* Determine the time to progression in patients treated with these regimens.\n\nOUTLINE: This is a pilot study.\n\nPatients receive high-dose interleukin-2 IV over 15 minutes twice daily on days 1 and 15 and 3 times daily on days 2-5 and 16-19. Patients also receive oral genistein twice daily on days 10-19.\n\nAfter completion of study treatment, patients are followed periodically.\n\nPROJECTED ACCRUAL: A total of 15 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Documented histologically confirmed malignant melanoma or renal clear cell carcinoma\n\n * Metastatic disease\n* At least 1 measurable lesion that can be accurately measured in at least one dimension with longest diameter \\> 20 mm using conventional techniques OR \\> 10 mm with spiral CT scan\n\n * If the measurable disease is restricted to a solitary lesion, its neoplastic nature should be confirmed by cytology/histology\n * Clinical lesions will only be considered measurable when they are superficial (e.g., skin nodules or palpable lymph nodes)\n * The following are considered non-measurable lesions:\n\n * Bone lesions\n * Leptomeningeal disease\n * Ascites\n * Pleural/pericardial effusion\n * Inflammatory breast disease\n * Lymphangitis cutis/pulmonis\n * Cystic lesions\n * Abdominal masses that are not confirmed and followed by imaging techniques\n* No CNS metastases by CT scan or MRI\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status \\< 2\n* Life expectancy ≥ 4 months\n* Serum creatinine \\< 2.0 mg/dL OR creatinine clearance \\> 50 mL/min\n* Bilirubin normal\n* Platelets \\> 100,000/mm³\n* WBC \\> 3,500/mm³\n* No evidence of congestive heart failure\n* No symptom of coronary artery disease\n* No serious cardiac arrhythmias\n* A pretreatment cardiac stress test must be performed within 42 days of IL-2 treatment if any cardiac symptoms present (patients with documented ischemia on the pretreatment cardiac stress test will be excluded from the study)\n* Adequate pulmonary reserve\n\n * FEV\\_1 \\> 75% of predicted\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* Negative pregnancy test\n* No known HIV-positive patients\n* No evidence of active infection requiring antibiotic therapy\n* No contraindication to treatment with pressor agents\n* No significant medical disease which, in the opinion of the investigator, may interfere with completion of the study\n* No history of another malignancy other than basal cell skin cancer within 5 years\n\nPRIOR CONCURRENT THERAPY:\n\n* Recovered from all toxic effects of prior therapy\n* No radiotherapy, chemotherapy, or immunotherapy in the 4 weeks prior to the first dose of the study treatment\n* No systemic corticosteroids in the 4 weeks prior to treatment\n* No previous investigational agent within 4 weeks prior to the start of the study\n* No prior interleukin-2 therapy\n* No organ allografts allowed\n* No concurrent radiotherapy, chemotherapy, or immunotherapy\n* No concurrent corticosteroids\n* No concurrent chronic medication for asthma'}, 'identificationModule': {'nctId': 'NCT00276835', 'briefTitle': 'Genistein and Interleukin-2 in Treating Patients With Metastatic Melanoma or Kidney Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'A Pilot Study of the Effect of Genistein in Combination With High-Dose Interleukin-2 on Cell Expansion and Gene Expression in Patients With Metastatic Melanoma or Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'NU 04V1'}, 'secondaryIdInfos': [{'id': 'NU-04V1'}, {'id': 'CHIR-NU-04V1'}, {'id': 'NU-IRB-0310-083'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Genistein and Interleukin-2', 'interventionNames': ['Biological: High-dose interleukin-2', 'Dietary Supplement: genistein']}], 'interventions': [{'name': 'High-dose interleukin-2', 'type': 'BIOLOGICAL', 'otherNames': ['IL-2', 'Aldesleukin', 'Proleukin'], 'description': 'Administered days 1-5, and 15-19; the patient will receive 600,000 IU/kg IL-2 by intravenous infusion over 15 minutes every 8 hours (on day 1 and day 15, patients will receive a maximum of 2 doses per day; on all other days in the cycle patients will receive a maximum of 3 doses per day)', 'armGroupLabels': ['Genistein and Interleukin-2']}, {'name': 'genistein', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['isoflavone'], 'description': 'Starting on day 10 and continuing through day 19, genistein will be administered orally at a dose of 600mg/day in two divided doses (i.e. 300mg po bid x 10 days)', 'armGroupLabels': ['Genistein and Interleukin-2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611-3013', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center at Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Timothy M. Kuzel, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Robert H. Lurie Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Timothy Kuzel, MD', 'investigatorFullName': 'Timothy Kuzel', 'investigatorAffiliation': 'Northwestern University'}}}}