Bryostatin and Vincristine in B-Cell Malignancies
A Phase I Trial of Combination Bryostatin 1 (NSC 339555) and Vincristine in B-Cell Malignancies
3 other identifiers
interventional
18
1 country
1
Brief Summary
This phase I trial is studying the side effects and best dose of bryostatin-1 when given together with vincristine in treating patients with chronic lymphocytic leukemia, non-Hodgkin's lymphoma, or multiple myeloma. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 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
Study Start
First participant enrolled
May 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 1, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2001
CompletedFirst Posted
Study publicly available on registry
March 19, 2004
CompletedJanuary 11, 2013
January 1, 2013
3.2 years
November 1, 1999
January 10, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
MTD
2 weeks
Response rates
Up to 11 years
Study Arms (1)
Treatment (bryostatin 1, vincristine sulfate)
EXPERIMENTALPatients receive bryostatin 1 IV over 24 hours followed immediately by vincristine IV. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients completing 6 courses of therapy may receive subsequent courses every 3 weeks and then every 4 weeks after 24 months of treatment. Patients may return to a 2- or 3-week treatment course at the discretion of the principal investigator. Cohorts of 3 patients receive escalating doses of bryostatin 1 until the MTD is determined. The MTD is defined as the dose preceding that at which at least 1 of 3 patients experience dose-limiting toxicity.
Interventions
Given IV
Given IV
Eligibility Criteria
You may qualify if:
- Patients with biopsy proven B-cell malignancies \[e.g. chronic lymphocytic leukemia (CLL), non-Hodgkin's lymphoma (NHL), multiple myeloma (MM)\]; HIV-associated lymphomas and acute leukemias are not eligible
- Performance status: ECOG 0, 1, or 2
- Life expectancy of at least 12 weeks
- Patients with aggressive NHL will be enrolled after having failed all possible therapy with curative intent
- Patients with CLL must have failed an alkylating agent-containing regimen as well as fludarabine chemotherapy
- Patients with multiple myeloma must have received at least one prior chemotherapy regimen and not be eligible for a dose intensification treatment approach
- 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 3 weeks (6 weeks for BCNU and mitomycin C) and recovered from all treatment related toxicity
- Prior vincristine therapy is allowed
- Sexually active men and women must use an accepted and effective method of contraception
- In women of child-bearing age, a pregnancy test may be done at the discretion of the investigator
- Must have given written informed consent
You may not qualify if:
- Patients with brain metastasis, leptomeningeal involvement, primary CNS NHL, and acute leukemia are ineligible
- Patients with HIV infection are ineligible
- WBC \< 3000/ul
- Granulocytes \< 1500/ul
- Platelets \< 50,000/ul
- Hemoglobin =\< 8.5 g/dl
- Bilirubin \> 1.5 mg/dl
- AST and ALT \> 2 times normal
- Creatinine \> 2.0 mg/dl, and/or actual creatinine clearance \< 40 ml/min/1.73 m\^2; all patients are required to have a 24 hr creatinine clearance
- Clinical evidence of bleeding diathesis
- ECOG Performance status 3 or 4
- Patients who are pregnant or lactating; vincristine can cause fetal harm
- Patients with clinically apparent neuropathy are ineligible (\>= grade 2 neuropathy)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Case Western Reserve University
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brenda Cooper
Case Western Reserve University
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
November 1, 1999
First Posted
March 19, 2004
Study Start
May 1, 1998
Primary Completion
July 1, 2001
Last Updated
January 11, 2013
Record last verified: 2013-01