Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
18 participants
INTERVENTIONAL
1998-05-31
Brief Summary
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Detailed Description
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I. To determine the maximum tolerated dose of bryostatin 1 as a 24 hour infusion and vincristine when administered sequentially.
II. To determine the effect of this combination on programmed cell death (apoptosis).
III. To determine the immunomodulatory effect of bryostatin 1. IV. To observe patients for clinical antitumor response after giving combination bryostatin 1 and vincristine.
OUTLINE: This is a dose-escalation study of bryostatin 1.
Patients 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 maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 1 of 3 patients experience dose-limiting toxicity.
Patients are followed every 3 months.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (bryostatin 1, vincristine sulfate)
Patients 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.
bryostatin 1
Given IV
vincristine sulfate
Given IV
laboratory biomarker analysis
Correlative studies
Interventions
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bryostatin 1
Given IV
vincristine sulfate
Given IV
laboratory biomarker analysis
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Brenda Cooper
Role: PRINCIPAL_INVESTIGATOR
Case Western Reserve University
Locations
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Case Western Reserve University
Cleveland, Ohio, United States
Countries
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Other Identifiers
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CWRU 3Y97
Identifier Type: -
Identifier Source: secondary_id
NCI-2012-03120
Identifier Type: -
Identifier Source: org_study_id
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