Bryostatin-1 in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
NCT ID: NCT00002725
Last Updated: 2013-02-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
35 participants
INTERVENTIONAL
1996-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bryostatin 1 in Treating Patients With Recurrent or Refractory Hodgkin's Disease
NCT00003936
Bryostatin 1 in Treating Patients With Relapsed Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
NCT00002908
Bryostatin 1 Plus Vincristine in Treating Patients With Progressive or Relapsed Non-Hodgkin's Lymphoma After Bone Marrow or Stem Cell Transplantation
NCT00058305
Bryostatin + Fludarabine in Treating Patients With Chronic Lymphocytic Leukemia or Relapsed Indolent Non-Hodgkin's Lymphoma
NCT00005580
Irinotecan in Treating Patients With Recurrent or Refractory Non-Hodgkin's Lymphoma
NCT00003245
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm I
Single-Agent Chemotherapy/Differentiation Therapy. Bryostatin 1, BRYO, NSC-339555.
bryostatin 1
chemotherapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
bryostatin 1
chemotherapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jorge E. Romaguera, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MDA-DM-95061
Identifier Type: -
Identifier Source: secondary_id
NCI-T95-0035D
Identifier Type: -
Identifier Source: secondary_id
CDR0000064591
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02239
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.