Bryostatin 1 Plus Vincristine in Treating Patients With Recurrent or Refractory HIV-Related Lymphoma
A Phase I Trial of Combination Bryostatin-1 and Vincristine in HIV-Related B-cell Neoplasms
4 other identifiers
interventional
12
1 country
1
Brief Summary
Phase I trial to study the effectiveness of bryostatin 1 plus vincristine in treating patients who have recurrent or refractory lymphoma. Drugs used in chemotherapy 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 them more sensitive to the drug
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2001
CompletedStudy Start
First participant enrolled
November 1, 2001
CompletedFirst Posted
Study publicly available on registry
January 27, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2003
CompletedJanuary 25, 2013
January 1, 2013
1.7 years
August 10, 2001
January 24, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
MTD of bryostatin-1 defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
4 weeks
Secondary Outcomes (2)
Dose-limiting toxicities
4 weeks
Immunomodulatory effects of this combination
Up to 2 years
Study Arms (1)
Treatment (bryostatin 1, vincristine sulfate)
EXPERIMENTALPatients receive bryostatin 1 IV continuously on days 1 and 15 and vincristine IV over 5 minutes on days 2 and 16. Treatment continues every 4 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
Interventions
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- Histologically confirmed B-cell lymphoma
- Eligible subtypes:
- Intermediate or high-grade non-Hodgkin's lymphoma (NHL), defined as follicular large cell, mantle cell, diffuse mixed cell, diffuse large cell and variants, Burkitt or Burkitt-like, or unclassifiable aggressive histologies
- Body cavity-based lymphoma or primary effusion lymphoma
- Evidence of HIV infection
- Received at least 1 prior systemic chemotherapy regimen with failure to respond or relapse after completion of first-line therapy, including one of the following doxorubicin-based combinations:
- Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP)
- Infusional cyclophosphamide, doxorubicin, and etoposide (CDE)
- Etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin (EPOCH)
- Evaluable disease outside of prior radiation port
- No CNS parenchymal or leptomeningeal involvement
- No primary CNS NHL
- No HTLV-1-associated leukemia or lymphoma
- Performance status - Karnofsky 70-100%
- At least 12 weeks
- +32 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AIDS - Associated Malignancies Clinical Trials Consortium
Rockville, Maryland, 20850, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scot Remick
AIDS Associated Malignancies Clinical Trials Consortium
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2001
First Posted
January 27, 2003
Study Start
November 1, 2001
Primary Completion
July 1, 2003
Last Updated
January 25, 2013
Record last verified: 2013-01