Ignite Creation Date:
2024-05-05 @ 10:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003693
Status:
COMPLETED
Last Update Posted:
2018-10-25
First Post:
1999-11-01
Brief Title:
Dolastatin 10 in Treating Patients With Refractory or Relapsed Acute Leukemia Myelodysplastic Syndrome or Chronic Myelogenous Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase I Study of Dolastatin-10 in Acute Leukemias Myelodysplastic Syndromes and Chronic Myeloid Leukemia in Blast Phase
Status:
COMPLETED
Status Verified Date:
2018-10
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 I trial to study the effectiveness of dolastatin 10 in treating patients who have refractory or relapsed acute leukemia chronic myelogenous leukemia in blast phase or myelodysplastic syndrome
PURPOSE Phase I trial to study the effectiveness of dolastatin 10 in treating patients who have refractory or relapsed acute leukemia chronic myelogenous leukemia in blast phase or myelodysplastic syndrome
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and dose limiting toxicity of dolastatin 10 in patients with chronic myelogenous leukemia in blast phase refractory or relapsed acute leukemia or myelodysplastic syndromes II Assess the possible antileukemia effect of this treatment in these patients
OUTLINE This is a dose escalation study Patients receive dolastatin 10 intravenous IV bolus once every 3 weeks Patients receive 2-12 courses of therapy in the absence of disease progression and unacceptable toxicity In the absence of dose limiting toxicity DLT in the first cohort of 3 patients subsequent cohorts of 3 patients each receive escalating doses of dolastatin 10 If DLT occurs in 2 of 3 patients at a given dose level then dose escalation ceases and the next lower dose is declared the maximum tolerated dose Patients are followed until death
PROJECTED ACCRUAL This study will accrue up to 25 patients within 8 months
OUTLINE This is a dose escalation study Patients receive dolastatin 10 intravenous IV bolus once every 3 weeks Patients receive 2-12 courses of therapy in the absence of disease progression and unacceptable toxicity In the absence of dose limiting toxicity DLT in the first cohort of 3 patients subsequent cohorts of 3 patients each receive escalating doses of dolastatin 10 If DLT occurs in 2 of 3 patients at a given dose level then dose escalation ceases and the next lower dose is declared the maximum tolerated dose Patients are followed until death
PROJECTED ACCRUAL This study will accrue up to 25 patients within 8 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000066796 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| U01CA062461 | NIH | None | None |
| P30CA016672 | NIH | None | None |
| MDA-DM-98187 | OTHER | None | None |
| NCI-T98-0001 | None | None | None |