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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002725 |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of bryostatin-1 in treating patients with recurrent non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
Lymphoma |
Drug: bryostatin 1 Procedure: chemotherapy |
Phase II |
MedlinePlus related topics: | Cancer Lymphoma |
ChemIDplus related topics: | Bryostatin 1 |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | PHASE II EVALUATION OF BRYOSTATIN-1 (NSC 339555) IN NON-HODGKIN'S LYMPHOMA |
Study Start Date: | August 1996 |
OBJECTIVES: I. Determine the response to bryostatin 1 (BRYO) administered weekly for 3 weeks in patients with relapsed non-Hodgkin's lymphoma. II. Assess the toxic effects of this treatment. III. Establish the correlation between PKC isoenzyme activity and BRYO function in lymphoma cells and normal lymphocytes. IV. Determine the pharmacokinetic profile of BRYO and its relationship to pharmacodynamics.
OUTLINE: Single-Agent Chemotherapy/Differentiation Therapy. Bryostatin 1, BRYO, NSC-339555.
PROJECTED ACCRUAL: In each stratum, a total of 35 patients will be entered over 1 year if there are at least 2 responses in the first 12 patients.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Histologically confirmed non-Hodgkin's lymphoma Working formulation low-, intermediate-, and high-grade histologies eligible Mantle cell and marginal zone lymphoma eligible Relapse after at least 1 doxorubicin-containing regimen required No more than 2 prior chemotherapy regimens One prior biologic therapy in addition to the 2 prior chemotherapy regimens allowed No prior bone marrow transplantation Ineligible for treatment on higher priority protocols Patients eligible for bone marrow transplantation may be treated to reduce tumor bulk Bidimensionally measurable disease required No history of primary or metastatic CNS disease
PATIENT CHARACTERISTICS: Age: Any age Performance status: Zubrod 0-2 Life expectancy: Greater than 12 weeks Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.8 mg/dL Transaminases no greater than 2.5 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 70 mL/min Other: No HIV antibody No serious intercurrent illness No pregnant or nursing women Effective contraception required of fertile patients throughout study and for 1 year thereafter
PRIOR CONCURRENT THERAPY: See Disease Characteristics At least 4 weeks since prior therapy (6 weeks since mitomycin) and recovered
United States, Texas | |||||
University of Texas - MD Anderson Cancer Center | |||||
Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Jorge E. Romaguera, MD | M.D. Anderson Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000064591, MDA-DM-95061, NCI-T95-0035D |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002725 |
Health Authority: | United States: Federal Government |
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