Bryostatin 1 Plus Vincristine in Treating Patients With Progressive or Relapsed Non-Hodgkin's Lymphoma After Bone Marrow or Stem Cell Transplantation

January 9, 2013 updated by: National Cancer Institute (NCI)

A Phase II Study of Bryostatin 1 and Vincristine in Patients With Low or Intermediate Grade Non-Hodgkin's Lymphoma Progressing or Relapsing After a Prior Autologous Bone Marrow or Stem Cell Transplant

Phase II trial to study the effectiveness of combining bryostatin 1 with vincristine in treating patients who have progressive or relapsed non-Hodgkin's lymphoma after autologous bone marrow transplantation or autologous stem cell transplantation. Drugs used in chemotherapy such as vincristine use different ways to stop cancer cells from dividing so they stop growing or die. Bryostatin 1 may help vincristine kill more cancer cells by making the cells more sensitive to the drug

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To evaluate response rate when bryostatin 1 is given in combination with vincristine in patients with low and intermediate grade non-Hodgkin's lymphoma who have progressed or relapsed following an autologous bone marrow or stem cell transplant.

II. To determine if blunting of apoptotic response (with two or more consecutive apoptotic fractions) following treatment using annexin V staining of peripheral blood CD5+ and CD19+ lymphocytes by flow cytometry is predictive of outcome (i.e. lack of clinical response).

III. To prospectively evaluate the incidence of > grade 3 myelotoxicity with this regimen.

OUTLINE: This is a multicenter study.

Patients receive bryostatin 1 IV over 24 hours on days 1 and 15 and vincristine IV on days 2 and 16. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients without disease progression after 6 courses may continue therapy with bryostatin 1 IV over 24 hours on days 1 and 22 and vincristine IV on days 2 and 23. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 2-5 years, and then annually thereafter.

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients must have biopsy proven relapsed or progressive low or intermediate grade non-Hodgkin's lymphoma (by REAL classification); after prior autologous bone marrow transplantation or peripheral blood stem cell rescue
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan
  • Patients must have received a prior autologous bone marrow or peripheral blood stem cell rescue to be eligible for this trial (there is no specified time interval from transplant prior to enrollment on study; at least 4 weeks must have elapsed since prior large-field radiation therapy; patients must have been off previous anti-cancer therapy for at least 4 weeks and recovered from all treatment related toxicity; prior vincristine therapy is allowed
  • Life expectancy of greater than 8-10 weeks
  • ECOG performance status 0-2
  • Absolute neutrophil count >= 1,250/uL
  • Platelets >= 50,000/uL
  • Hemoglobin >= 8.5 g /dl
  • Total bilirubin =< 2.0 mg/dl
  • AST(SGOT)/ALT(SGPT) =< 3 X normal
  • Creatinine =< 2.0 mg/dl
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Patients requiring concomitant anticancer therapy are excluded
  • Patients with known brain metastases or leptomeningeal involvement should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
  • Patients who have had a prior allogeneic transplant are not eligible
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant and lactating women are excluded from this study
  • HIV infection
  • Patients with clinically apparent neuropathy (>= grade 2)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Treatment (bryostatin 1, vincristine sulfate)

Patients receive bryostatin 1 IV over 24 hours on days 1 and 15 and vincristine IV on days 2 and 16. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients without disease progression after 6 courses may continue therapy with bryostatin 1 IV over 24 hours on days 1 and 22 and vincristine IV on days 2 and 23. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Other: laboratory biomarker analysis
Correlative studies
Drug: vincristine sulfate
Given IV
Other Names:
  • VCR
  • leurocristine sulfate
  • Vincasar PFS
Drug: bryostatin 1
Given IV
Other Names:
  • B705008K112
  • BRYO
  • Bryostatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response in terms of sustained increase in apoptotic fractions
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response duration
Time Frame: Up to 5 years
Will be analyzed using Kaplan-Meier methods.
Up to 5 years
Incidence of greater than or equal to grade 3 myelotoxicity
Time Frame: Up to 5 years
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

April 7, 2003

First Submitted That Met QC Criteria

April 8, 2003

First Posted (Estimate)

April 9, 2003

Study Record Updates

Last Update Posted (Estimate)

January 10, 2013

Last Update Submitted That Met QC Criteria

January 9, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2012-03116
  • U01CA062502 (U.S. NIH Grant/Contract)
  • ICC 2402

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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