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Bryostatin-1 in Treating Patients With Recurrent Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002725
First received: November 1, 1999
Last updated: February 4, 2013
Last verified: October 2000
History of Changes
  Purpose

Phase II trial to study the effectiveness of bryostatin-1 in treating patients with recurrent non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.


Condition Intervention Phase
Lymphoma
 Drug: bryostatin 1
Drug: chemotherapy
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: PHASE II EVALUATION OF BRYOSTATIN-1 (NSC 339555) IN NON-HODGKIN'S LYMPHOMA

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources

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

Enrollment: 35
Study Start Date: August 1996
Primary Completion Date: April 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Single-Agent Chemotherapy/Differentiation Therapy. Bryostatin 1, BRYO, NSC-339555.
 Drug: bryostatin 1 Drug: chemotherapy

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.

  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
  • 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

  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
National Cancer Institute (NCI)
Investigators
Study Chair: Jorge E. Romaguera, MD M.D. Anderson Cancer Center
  More Information

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

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00002725     History of Changes
Other Study ID Numbers: NCI-2012-02239, MDA-DM-95061, NCI-T95-0035D, CDR0000064591
Study First Received: November 1, 1999
Last Updated: February 4, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Bryostatin 1
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013