Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003997
Status:
COMPLETED
Last Update Posted:
2013-02-08
First Post:
1999-11-01
Brief Title:
6-Hydroxymethylacylfulvene in Treating Patients With Refractory Myelodysplastic Syndrome Acute Myeloid Leukemia Acute Lymphocytic Leukemia or Blastic Phase Chronic Myelogenous Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of MGI-114 NSC683863 in Patients With Refractory Myelodysplastic Syndromes Acute Leukemia and Chronic Myelogenous Leukemia in Blastic Phase CML-BP
Status:
COMPLETED
Status Verified Date:
2001-01
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:
Phase I trial to study the effectiveness of 6-hydroxymethylacylfulvene in treating patients who have refractory myelodysplastic syndrome acute myeloid leukemia acute lymphocytic leukemia or blastic phase chronic myelogenous leukemia Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose for 6-hydroxymethylacylfulvene in patients with refractory myelodysplastic syndrome acute myeloid leukemia acute lymphocytic leukemia or blastic phase chronic myelogenous leukemia
II Determine the qualitative and quantitative toxicities of this treatment in these patients
III Determine the duration and reversibility of the qualitative and quantitative toxicities of this treatment in these patients
IV Evaluate in a preliminary manner the antileukemic activity of this treatment in these patients
V Assess relative mRNA levels of selected NER genes ERCC1 ERCC2 and ERCC3 in tumor tissues of patients treated with this regimen and correlate with clinical outcome
OUTLINE This is a dose escalation study
Patients receive 6-hydroxymethylacylfulvene HMAF IV over 5 minutes on days 1-5 Treatment repeats every 3-4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3 patients receive escalating doses of HMAF The maximum tolerated dose is defined as the dose at which dose limiting toxicity occurs in at least 40 of patients
Patients are followed every 3 months for 1 year and then every 6 months thereafter
I Determine the maximum tolerated dose for 6-hydroxymethylacylfulvene in patients with refractory myelodysplastic syndrome acute myeloid leukemia acute lymphocytic leukemia or blastic phase chronic myelogenous leukemia
II Determine the qualitative and quantitative toxicities of this treatment in these patients
III Determine the duration and reversibility of the qualitative and quantitative toxicities of this treatment in these patients
IV Evaluate in a preliminary manner the antileukemic activity of this treatment in these patients
V Assess relative mRNA levels of selected NER genes ERCC1 ERCC2 and ERCC3 in tumor tissues of patients treated with this regimen and correlate with clinical outcome
OUTLINE This is a dose escalation study
Patients receive 6-hydroxymethylacylfulvene HMAF IV over 5 minutes on days 1-5 Treatment repeats every 3-4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity Cohorts of 3 patients receive escalating doses of HMAF The maximum tolerated dose is defined as the dose at which dose limiting toxicity occurs in at least 40 of patients
Patients are followed every 3 months for 1 year and then every 6 months thereafter
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 |
|---|---|---|---|
| CDR0000067207 | REGISTRY | PDQ Physician Data Query | None |
| MDA-ID-99060 | None | None | None |
| NCI-T99-0043 | None | None | None |