Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005579
Status:
COMPLETED
Last Update Posted:
2013-06-26
First Post:
2000-05-02
Brief Title:
Dolastatin 10 in Treating Patients With Indolent Lymphoma Waldenstroms Macroglobulinemia or Chronic Lymphocytic Leukemia
Sponsor:
University of Vermont
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Dolastin 10 in Indolent Lymphoma and Chronic Lymphocytic Leukemia
Status:
COMPLETED
Status Verified Date:
2002-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of dolastatin 10 in treating patients with indolent lymphoma Waldenstroms macroglobulinemia or chronic lymphocytic leukemia
PURPOSE Phase II trial to study the effectiveness of dolastatin 10 in treating patients with indolent lymphoma Waldenstroms macroglobulinemia or chronic lymphocytic leukemia
Detailed Description:
OBJECTIVES
Estimate the efficacy of dolastatin 10 in patients with indolent lymphoma Waldenstroms macroglobulinemia or chronic lymphocytic leukemia
Evaluate the qualitative and quantitative toxicities of dolastatin 10 in this patient population
Investigate the mechanism of action of dolastatin 10 in regards to apoptosis and effects of microtubules
OUTLINE This is an open-label multicenter study Patients are stratified by disease chronic lymphocytic leukemia vs indolent lymphoma vs Waldenstroms macroglobulinemia
All patients receive dolastatin 10 IV bolus every 3 weeks Patients continue treatment until disease progression unacceptable toxicity or patients withdrawal from the study
PROJECTED ACCRUAL A maximum of 74 patients will be accrued for this study over 15 months
Estimate the efficacy of dolastatin 10 in patients with indolent lymphoma Waldenstroms macroglobulinemia or chronic lymphocytic leukemia
Evaluate the qualitative and quantitative toxicities of dolastatin 10 in this patient population
Investigate the mechanism of action of dolastatin 10 in regards to apoptosis and effects of microtubules
OUTLINE This is an open-label multicenter study Patients are stratified by disease chronic lymphocytic leukemia vs indolent lymphoma vs Waldenstroms macroglobulinemia
All patients receive dolastatin 10 IV bolus every 3 weeks Patients continue treatment until disease progression unacceptable toxicity or patients withdrawal from the study
PROJECTED ACCRUAL A maximum of 74 patients will be accrued for this study over 15 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T98-0007 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066360 | REGISTRY | None | None |