Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2025-12-29 @ 7:35 PM
Study NCT ID:
NCT00003166
Status:
COMPLETED
Last Update Posted:
2013-01-11
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bryostatin and Vincristine in B-Cell Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016400', 'term': 'Lymphoma, Large-Cell, Immunoblastic'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}, {'id': 'D020522', 'term': 'Lymphoma, Mantle-Cell'}, {'id': 'D015451', 'term': 'Leukemia, Lymphocytic, Chronic, B-Cell'}, {'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'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': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D015448', 'term': 'Leukemia, B-Cell'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C046785', 'term': 'bryostatin 1'}, {'id': 'D054713', 'term': 'Bryostatins'}, {'id': 'D014750', 'term': 'Vincristine'}], 'ancestors': [{'id': 'D000095702', 'term': 'Polyether Toxins'}, {'id': 'D000095662', 'term': 'Polyether Polyketides'}, {'id': 'D004988', 'term': 'Ethers, Cyclic'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D008387', 'term': 'Marine Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'lastUpdateSubmitDate': '2013-01-10', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-03-18', 'lastUpdatePostDateStruct': {'date': '2013-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MTD', 'timeFrame': '2 weeks'}, {'measure': 'Response rates', 'timeFrame': 'Up to 11 years'}]}, 'conditionsModule': {'conditions': ['Recurrent Adult Burkitt Lymphoma', 'Recurrent Adult Diffuse Large Cell Lymphoma', 'Recurrent Adult Diffuse Mixed Cell Lymphoma', 'Recurrent Adult Immunoblastic Large Cell Lymphoma', 'Recurrent Adult Lymphoblastic Lymphoma', 'Recurrent Grade 3 Follicular Lymphoma', 'Recurrent Mantle Cell Lymphoma', 'Refractory Chronic Lymphocytic Leukemia', 'Refractory Multiple Myeloma', 'Stage III Multiple Myeloma']}, 'descriptionModule': {'briefSummary': "This phase I trial is studying the side effects and best dose of bryostatin-1 when given together with vincristine in treating patients with chronic lymphocytic leukemia, non-Hodgkin's lymphoma, or multiple myeloma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells", 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the maximum tolerated dose of bryostatin 1 as a 24 hour infusion and vincristine when administered sequentially.\n\nII. To determine the effect of this combination on programmed cell death (apoptosis).\n\nIII. To determine the immunomodulatory effect of bryostatin 1. IV. To observe patients for clinical antitumor response after giving combination bryostatin 1 and vincristine.\n\nOUTLINE: This is a dose-escalation study of bryostatin 1.\n\nPatients receive bryostatin 1 IV over 24 hours followed immediately by vincristine IV. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients completing 6 courses of therapy may receive subsequent courses every 3 weeks and then every 4 weeks after 24 months of treatment. Patients may return to a 2- or 3-week treatment course at the discretion of the principal investigator.\n\nCohorts of 3 patients receive escalating doses of bryostatin 1 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 1 of 3 patients experience dose-limiting toxicity.\n\nPatients are followed every 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with biopsy proven B-cell malignancies \\[e.g. chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), multiple myeloma (MM)\\]; HIV-associated lymphomas and acute leukemias are not eligible\n* Performance status: ECOG 0, 1, or 2\n* Life expectancy of at least 12 weeks\n* Patients with aggressive NHL will be enrolled after having failed all possible therapy with curative intent\n* Patients with CLL must have failed an alkylating agent-containing regimen as well as fludarabine chemotherapy\n* Patients with multiple myeloma must have received at least one prior chemotherapy regimen and not be eligible for a dose intensification treatment approach\n* At least 4 weeks must have elapsed since prior large-field radiation therapy\n* Patients must have been off previous anti-cancer therapy for at least 3 weeks (6 weeks for BCNU and mitomycin C) and recovered from all treatment related toxicity\n* Prior vincristine therapy is allowed\n* Sexually active men and women must use an accepted and effective method of contraception\n* In women of child-bearing age, a pregnancy test may be done at the discretion of the investigator\n* Must have given written informed consent\n\nExclusion Criteria:\n\n* Patients with brain metastasis, leptomeningeal involvement, primary CNS NHL, and acute leukemia are ineligible\n* Patients with HIV infection are ineligible\n* WBC \\< 3000/ul\n* Granulocytes \\< 1500/ul\n* Platelets \\< 50,000/ul\n* Hemoglobin =\\< 8.5 g/dl\n* Bilirubin \\> 1.5 mg/dl\n* AST and ALT \\> 2 times normal\n* Creatinine \\> 2.0 mg/dl, and/or actual creatinine clearance \\< 40 ml/min/1.73 m\\^2; all patients are required to have a 24 hr creatinine clearance\n* Clinical evidence of bleeding diathesis\n* ECOG Performance status 3 or 4\n* Patients who are pregnant or lactating; vincristine can cause fetal harm\n* Patients with clinically apparent neuropathy are ineligible (\\>= grade 2 neuropathy)"}, 'identificationModule': {'nctId': 'NCT00003166', 'briefTitle': 'Bryostatin and Vincristine in B-Cell Malignancies', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase I Trial of Combination Bryostatin 1 (NSC 339555) and Vincristine in B-Cell Malignancies', 'orgStudyIdInfo': {'id': 'NCI-2012-03120'}, 'secondaryIdInfos': [{'id': 'CWRU 3Y97'}, {'id': 'U01CA062502', 'link': 'https://reporter.nih.gov/quickSearch/U01CA062502', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment (bryostatin 1, vincristine sulfate)', 'description': 'Patients receive bryostatin 1 IV over 24 hours followed immediately by vincristine IV. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients completing 6 courses of therapy may receive subsequent courses every 3 weeks and then every 4 weeks after 24 months of treatment. Patients may return to a 2- or 3-week treatment course at the discretion of the principal investigator.\n\nCohorts of 3 patients receive escalating doses of bryostatin 1 until the MTD is determined. The MTD is defined as the dose preceding that at which at least 1 of 3 patients experience dose-limiting toxicity.', 'interventionNames': ['Drug: bryostatin 1', 'Drug: vincristine sulfate', 'Other: laboratory biomarker analysis']}], 'interventions': [{'name': 'bryostatin 1', 'type': 'DRUG', 'otherNames': ['B705008K112', 'BRYO', 'Bryostatin'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (bryostatin 1, vincristine sulfate)']}, {'name': 'vincristine sulfate', 'type': 'DRUG', 'otherNames': ['leurocristine sulfate', 'VCR', 'Vincasar PFS'], 'description': 'Given IV', 'armGroupLabels': ['Treatment (bryostatin 1, vincristine sulfate)']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Treatment (bryostatin 1, vincristine sulfate)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Brenda Cooper', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Western Reserve University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}