- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00002725
Bryostatin-1 in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
PHASE II EVALUATION OF BRYOSTATIN-1 (NSC 339555) IN NON-HODGKIN'S LYMPHOMA
Study Overview
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- University of Texas - MD Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I
Single-Agent Chemotherapy/Differentiation Therapy.
Bryostatin 1, BRYO, NSC-339555.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Jorge E. Romaguera, MD, M.D. Anderson Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult Burkitt lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent mantle cell lymphoma
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2012-02239
- MDA-DM-95061
- NCI-T95-0035D
- CDR0000064591 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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