ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  Related Studies  
Bryostatin-1 in Treating Patients With Recurrent Non-Hodgkin's Lymphoma

This study has been completed.

Sponsors and Collaborators: M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002725
  Purpose

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   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   PHASE II EVALUATION OF BRYOSTATIN-1 (NSC 339555) IN NON-HODGKIN'S LYMPHOMA

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   August 1996

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.

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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002725

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center    
      Houston, Texas, United States, 77030

Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Jorge E. Romaguera, MD     M.D. Anderson Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

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

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Leukemia, B-cell, chronic
Lymphoma, Mantle-Cell
Lymphoma, small cleaved-cell, diffuse
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Bryostatin 1
Lymphoblastic lymphoma
Mantle cell lymphoma
Lymphoma, large-cell, immunoblastic
Recurrence
Lymphoma, large-cell
Lymphoma, B-Cell
Burkitt's lymphoma
Lymphatic Diseases
B-cell lymphomas
Burkitt Lymphoma
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma
Follicular lymphoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Immune System Diseases
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2008




Links to all studies - primarily for crawlers