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| Tracking Information | |||||
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| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | November 16, 2008 | ||||
| Start Date ICMJE | May 1998 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00003166 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Combination Chemotherapy in Treating Patients With Chronic Lymphocytic Leukemia, Non-Hodgkin's Lymphoma, or Multiple Myeloma | ||||
| Official Title ICMJE | A Phase I Trial of Combination Bryostatin 1 (NSC 339555) and Vincristine in B-Cell Malignancies | ||||
| Brief Summary | RATIONALE: 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. PURPOSE: 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. |
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| Detailed Description | OBJECTIVES: I. Determine the maximum tolerated dose of bryostatin 1 when combined with vincristine in patients with B-cell malignancies. II. Assess clinical responses in patients treated with this regimen. OUTLINE: This is a dose-escalation study of bryostatin 1. 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. Cohorts 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. Patients are followed every 3 months. PROJECTED ACCRUAL: Approximately 18 patients will be accrued for this study within 12-15 months. |
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| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 18 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS: Histologically proven B-cell malignancies (e.g., chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), or multiple myeloma (MM)) Specific requirements for each disease: CLL patients must have failed prior chemotherapy with fludarabine and an alkylating agent Aggressive NHL patients must have failed all other possible curative therapies MM patients must have had at least 1 prior chemotherapy regimen and not be eligible for dose intensification treatment approach No brain metastasis or leptomeningeal involvement No primary CNS NHL, HIV-associated lymphoma, or acute leukemia PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 50,000/mm3 Hemoglobin greater than 8.5 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL AST and ALT no greater than 2 times normal No evidence of bleeding diathesis Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 40 mL/min Neurologic: No clinically apparent neuropathy (grade 2 or greater neuropathy) Other: HIV negative Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for carmustine and mitomycin) and recovered Prior vincristine allowed Endocrine therapy: No concurrent steroids Radiotherapy: At least 4 weeks since prior large-field radiotherapy Surgery: Not specified |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00003166 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000065967, CWRU-3Y97, NCI-T97-0062 | ||||
| Study Sponsor ICMJE | Case Comprehensive Cancer Center | ||||
| Collaborators ICMJE | National Cancer Institute (NCI) | ||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | July 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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