search
Back to results

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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bryostatin 1
chemotherapy
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas - MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

Single-Agent Chemotherapy/Differentiation Therapy. Bryostatin 1, BRYO, NSC-339555.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
February 4, 2013
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00002725
Brief Title
Bryostatin-1 in Treating Patients With Recurrent Non-Hodgkin's Lymphoma
Official Title
PHASE II EVALUATION OF BRYOSTATIN-1 (NSC 339555) IN NON-HODGKIN'S LYMPHOMA
Study Type
Interventional

2. Study Status

Record Verification Date
October 2000
Overall Recruitment Status
Completed
Study Start Date
August 1996 (undefined)
Primary Completion Date
April 2000 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Single-Agent Chemotherapy/Differentiation Therapy. Bryostatin 1, BRYO, NSC-339555.
Intervention Type
Drug
Intervention Name(s)
bryostatin 1
Intervention Type
Drug
Intervention Name(s)
chemotherapy

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge E. Romaguera, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs