Trials / Completed
CompletedNCT00003174
Bryostatin 1 Plus Cladribine in Treating Patients With Relapsed Chronic Lymphocytic Leukemia
Phase I Clinical Evaluation of Bryostatin 1 in Combination With 2-CdA in Patients With Relapsed CLL
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Barbara Ann Karmanos Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of cladribine when given with bryostatin 1 in treating patients with relapsed chronic lymphocytic leukemia.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose of cladribine when administered after bryostatin 1 in patients with relapsed chronic lymphocytic leukemia. * Determine the qualitative and quantitative toxic effects of this regimen in these patients. OUTLINE: This is a multicenter, dose-escalation study of cladribine. Patients receive bryostatin 1 IV continuously on days 1-3 immediately followed by cladribine IV continuously on days 4-8. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve complete remission (CR) receive 2 additional courses past CR. Cohorts of 3-6 patients receive escalating dose levels of cladribine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 3 weeks. PROJECTED ACCRUAL: A minimum of 15 patients will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | bryostatin 1 | |
| DRUG | cladribine |
Timeline
- Start date
- 1998-05-01
- Primary completion
- 2005-11-01
- Completion
- 2005-11-01
- First posted
- 2003-01-27
- Last updated
- 2014-04-24
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00003174. Inclusion in this directory is not an endorsement.