Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT00776802
Status:
WITHDRAWN
Last Update Posted:
2013-06-25
First Post:
2008-10-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GCS-100LE in Combination With Etoposide and Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C505531', 'term': 'GCS-100'}, {'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'C061400', 'term': 'etoposide phosphate'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}], 'ancestors': [{'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-21', 'studyFirstSubmitDate': '2008-10-19', 'studyFirstSubmitQcDate': '2008-10-20', 'lastUpdatePostDateStruct': {'date': '2013-06-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the maximum tolerated dose of GCS-100 in combination with etoposide and dexamethasone by comprehensive lab, pharmacokinetics, physical assessments, and PET-CT imaging.', 'timeFrame': 'Study Day 12 for toxicity, and 21-day cycles assessed every 2 cycles by physical and imaging assessments until disease progression'}], 'secondaryOutcomes': [{'measure': 'Overall response rate; correlate response to GCS-100 with the expression of galectin-3 in tumors; correlate serum galectin-3 levels with the administration of GCS-100', 'timeFrame': 'Baseline, Day 1, and Day 5 laboratory assessments'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GCS-100', 'Diffuse Large B-cell Lymphoma', 'DLBCL', 'Relapsed or refractory DLBCL', 'Etoposide; Dexamethasone'], 'conditions': ['Diffuse Large B-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'Phase 1/2, open-label, dose-escalation study to assess the safety and tolerability of GCS-100 in combination with etoposide and dexamethasone in patients with relapsed or refractory diffuse large B-cell lymphoma.', 'detailedDescription': 'This study will investigate the safety and efficacy of the combination of GCS-100 with etoposide and dexamethasone. In vitro data demonstrates potentiation of the killing of lymphoma cells when GCS-100 is combined with dexamethasone or etoposide (Linda Baum, unpublished data; Finbarr Cotter et al, Annals of Oncology, vol 16, 205, Suppl 5.) GCS-100 will be administered in increasing doses to define a maximum tolerated dose (MTD) in combination with these chemotherapeutic agents. When the MTD is defined, the cohort will be expanded to characterize the efficacy of this combination.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients who are 18 years of age or older with diffuse large B-cell cell lymphoma (DLBCL) relapsed or refractory after initial therapy who:\n\n * Are not candidates for autologous stem cell transplant.\n * Have relapsed after autologous or allogeneic stem cell transplant.\n * Have relapsed or refractory disease after 3 successive chemotherapy regimens.\n* ECOG Performance Score 0-2\n* Creatinine clearance \\> 60 mL/min/1.73 m2.\n* Total bilirubin ≤2.0 X Institutional Upper Limit of Normal (IULN)\n* AST (SGOT)/ALT (SGPT) ≤2.5 X IUNL, or ≤5X IUNL in patients with liver involvement of DLBCL\n* Absolute neutrophil count \\>1,000 /\\_L; hemoglobin \\>9 g/mL; platelet count \\> 75,000 /\\_L at screening.\n* Patients must be capable of understanding the purpose and risks of the study and able to provide written consent.\n* Patients must be willing and able to comply with the prescribed treatment protocol and evaluations\n\nExclusion Criteria:\n\n* Treatment with experimental (unlicensed) drug within 3 weeks of treatment.\n* Previous chemotherapy, or major surgery within 21 days prior to first study treatment, or radiation therapy within 6 weeks.\n* Rapidly progressive disease or organ function threatened by disease\n* Serious, uncontrolled active infections.\n* Serologically positive for HIV, HBV, or HCV.\n* Clinically significant cardiac, pulmonary, and/or hepatic dysfunction\n* Lymphoma involving the central nervous system\n* Female patients who are pregnant or breast feeding.\n* Patients not capable of understanding the purpose and risks of the study and or unable to provide written consent.\n* Patients not willing and or unable to comply with the prescribed treatment protocol and evaluations'}, 'identificationModule': {'nctId': 'NCT00776802', 'acronym': 'GCS-100LE', 'briefTitle': 'GCS-100LE in Combination With Etoposide and Dexamethasone in Relapsed or Refractory Diffuse Large B-Cell Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'La Jolla Pharmaceutical Company'}, 'officialTitle': 'Phase 1/2 Study of GCS-100 in Combination With Etoposide and Dexamethasone in Relapsed or Refractory Diffuse Large B Cell Lymphoma', 'orgStudyIdInfo': {'id': 'PR-CS010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GCS-10', 'interventionNames': ['Drug: GCS-100', 'Drug: Etoposide; Dexamethasone']}], 'interventions': [{'name': 'GCS-100', 'type': 'DRUG', 'description': 'GCS-100 80 mg/m2 IV (in the vein) on Study Days 1, 2, 3, 4, and 5 of a 21-day course. Three or up to six patients will be enrolled in each cohort until the maximum tolerated dose is reached. The dose levels: 1) 80 mg/m2; 2) 120 mg/m2; 3) 160 mg/m2', 'armGroupLabels': ['GCS-10']}, {'name': 'Etoposide; Dexamethasone', 'type': 'DRUG', 'otherNames': ['Eposin', 'VP-16', 'Etopophos', 'Vepesid', 'Decadron'], 'description': 'Etoposide 100 mg/m2 on Study Days 3, 4 and 5; Dexamethasone 10 mg/m2 on Study Days 1, 2, 3, 4 and 5.', 'armGroupLabels': ['GCS-10']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Lauren Pinter-Brown, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCLA, Division of Hematology/Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'La Jolla Pharmaceutical Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}