PHASE II EVALUATION OF BRYOSTATIN-1 (NSC 339555) IN NON-HODGKIN'S LYMPHOMA
bryostatin 1
+ chemotherapy
Chronic Disease+29
+ DNA Virus Infections
+ Hematologic Diseases
Treatment Study
Summary
Study start date: August 1, 1996
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.35 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Bilirubin no greater than 1.8 mg/dL Transaminases no greater than 2.5 times normal Creatinine no greater than 1.5 mg/dL OR creatinine clearance greater than 70 mL/min 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: -At least 4 weeks since prior therapy (6 weeks since mitomycin) and recovered
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
University of Texas - MD Anderson Cancer Center
Houston, United StatesOpen University of Texas - MD Anderson Cancer Center in Google Maps