Bryostatin 1 in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of bryostatin 1 in treating patients who have relapsed non-Hodgkin's lymphoma or chronic lymphocytic leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Lymphoma |
Drug: bryostatin 1 Drug: vincristine sulfate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | PHASE II CLINICAL EVALUATION OF BRYOSTATIN 1 IN PATIENTS WITH RELAPSED NON-HODGKIN'S LYMPHOMA AND CLL |
| Study Start Date: | December 1996 |
| Study Completion Date: | November 2001 |
| Primary Completion Date: | February 2000 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Assess the efficacy of bryostatin 1 administered as a 72-hour infusion in patients with relapsed non-Hodgkin's lymphoma and chronic lymphocytic leukemia. II. Gain information regarding the toxicity and tolerability of escalated vincristine doses given after each bryostatin 1 infusion in cohorts of patients who fail to respond to bryostatin alone. III. Determine the qualitative and quantitative toxic effects of bryostatin 1 in these patients. IV. Determine the duration of response and survival following treatment with bryostatin 1.
OUTLINE: All patients receive bryostatin 1 by 72-hour continuous infusion every 2 weeks until disease progression or until 2 courses beyond documentation of complete remission. Response is assessed after every 4 courses. Patients with disease progression who continue to meet the eligibility criteria receive vincristine within 2 hours after completion of each bryostatin 1 infusion. Groups of 3-6 patients receive escalated doses of vincristine until the maximum tolerated dose with bryostatin 1 is determined. Courses repeat every 2 weeks, as above; no individual dose escalation is allowed. No concurrent steroids are permitted. Patients are followed for survival.
PROJECTED ACCRUAL: A total of 25 evaluable patients with low-grade NHL or CLL will be entered over approximately 20 months if there are 2-4 responses in the first 15 patients. A total of 20 evaluable patients with intermediate- or high-grade NHL will be entered over approximately 2 years if there are 1 or 2 responses in the first 10 patients.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: One of the following hematologic malignancies that has failed 1 or 2 prior front-line chemotherapy regimens and is ineligible for treatment of higher potential efficacy: Histologically confirmed chronic lymphocytic leukemia (CLL) Intermediate- or high-risk (RAI stage I-IV) disease Evidence of active disease required by at least one of the following for intermediate-risk CLL: One of the following B symptoms: Weight loss of 10% or more in previous 6 months Extreme fatigue Fever over 100 F without evidence of infection Night sweats Massive (more than 6 cm below left costal margin) or progressive splenomegaly Massive (more than 10 cm in longest diameter) or progressive lymphadenopathy Progressive lymphocytosis with more than 50% increase over 2-month period or anticipated doubling time of less than 12 months Progressive bone marrow failure as manifested by development or worsening of anemia and/or thrombocytopenia Autoimmune anemia and/or thrombocytopenia poorly responsive to corticosteroids Biopsy proven low-, intermediate-, or high-grade non-Hodgkin's lymphoma Transformed lymphoma allowed Measurable disease required Re-treatment on this study allowed if disease relapsed after a complete remission
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: ANC at least 1,500/mm3 (at least 1,000/mm3 in CLL patients with at least 30% marrow involvement) Platelets at least 100,000/mm3 (at least 50,000/mm3 in CLL patients with at least 30% marrow involvement) Hepatic: Bilirubin less than 1.5 mg/dL Transaminases less than 2.5 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of impaired cardiac status, e.g.: Severe coronary artery disease Cardiomyopathy Uncontrolled congestive heart failure Arrhythmia Other: No known AIDS or HIV infection No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer In situ cervical cancer Not pregnant or nursing Effective contraception required of fertile patients during and for 2 months after study
PRIOR CONCURRENT THERAPY: No concurrent therapy Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 4 weeks since chemotherapy (8 weeks since nitrosoureas or mitomycin) and recovered Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since radiotherapy and recovered Surgery: Not specified Other: No prior bone marrow transplant
Contacts and Locations| United States, Michigan | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201 | |
| Study Chair: | Ayad M. Al-Katib, MD, FACP | Barbara Ann Karmanos Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00002908 History of Changes |
| Other Study ID Numbers: | CDR0000065273, P30CA022453, WSU-C-1256, WSU-D-1256, NCI-T95-0058D |
| Study First Received: | November 1, 1999 |
| Last Updated: | April 3, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Barbara Ann Karmanos Cancer Institute:
|
refractory chronic lymphocytic leukemia recurrent small lymphocytic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma |
recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma splenic marginal zone lymphoma |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Vincristine |
Bryostatin 1 Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013