search
Back to results

6-Hydroxymethylacylfulvene in Treating Patients With Refractory Myelodysplastic Syndrome, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Blastic Phase Chronic Myelogenous Leukemia

Primary Purpose

Leukemia, Myelodysplastic Syndromes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
irofulven
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, blastic phase chronic myelogenous leukemia, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Diagnosis of refractory myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), acute lymphocytic leukemia, or blastic phase chronic myelogenous leukemia MDS and AML include: First salvage with primary refractory disease or first complete remission of no more than 12 months Second or greater salvage After the maximum tolerated dose is determined, AML patients with an intermediate prognosis (i.e., complete remission of more than 12 months, but less than 24 months) are eligible No candidates for curative therapies such as allogeneic bone marrow transplantation PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Bilirubin no greater than 1.5 mg/dL Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min No active congestive heart failure No uncontrolled angina No myocardial infarction within past 6 months No concurrent grade 4 infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No overt psychosis, mental disability, or other incompetency that would preclude obtaining informed consent No life threatening nonmalignant illness PRIOR CONCURRENT THERAPY: At least 2 weeks since prior biologic therapy and recovered No concurrent systemic anticancer biologic therapy At least 2 weeks since other prior chemotherapy and recovered Concurrent hydroxyurea allowed if needed to control blast counts No concurrent systemic anticancer chemotherapy At least 2 weeks since prior endocrine therapy and recovered Concurrent corticosteroids allowed if needed to control blast counts At least 2 weeks since prior radiotherapy and recovered No concurrent systemic radiotherapy No concurrent surgery At least 3 weeks since other prior investigational drugs (including analgesics or antiemetics) and recovered No other concurrent investigational drugs

Sites / Locations

  • University of Texas - MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm I

Arm Description

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.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
February 7, 2013
Sponsor
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00003997
Brief Title
6-Hydroxymethylacylfulvene in Treating Patients With Refractory Myelodysplastic Syndrome, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Blastic Phase Chronic Myelogenous Leukemia
Official Title
Phase I Study of MGI-114 (NSC#683863) in Patients With Refractory Myelodysplastic Syndromes, Acute Leukemia and Chronic Myelogenous Leukemia in Blastic Phase (CML-BP)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2001
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
October 2000 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelodysplastic Syndromes
Keywords
recurrent adult acute myeloid leukemia, recurrent adult acute lymphoblastic leukemia, blastic phase chronic myelogenous leukemia, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
irofulven

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of refractory myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), acute lymphocytic leukemia, or blastic phase chronic myelogenous leukemia MDS and AML include: First salvage with primary refractory disease or first complete remission of no more than 12 months Second or greater salvage After the maximum tolerated dose is determined, AML patients with an intermediate prognosis (i.e., complete remission of more than 12 months, but less than 24 months) are eligible No candidates for curative therapies such as allogeneic bone marrow transplantation PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Bilirubin no greater than 1.5 mg/dL Creatinine no greater than 1.5 mg/dL OR creatinine clearance at least 60 mL/min No active congestive heart failure No uncontrolled angina No myocardial infarction within past 6 months No concurrent grade 4 infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No overt psychosis, mental disability, or other incompetency that would preclude obtaining informed consent No life threatening nonmalignant illness PRIOR CONCURRENT THERAPY: At least 2 weeks since prior biologic therapy and recovered No concurrent systemic anticancer biologic therapy At least 2 weeks since other prior chemotherapy and recovered Concurrent hydroxyurea allowed if needed to control blast counts No concurrent systemic anticancer chemotherapy At least 2 weeks since prior endocrine therapy and recovered Concurrent corticosteroids allowed if needed to control blast counts At least 2 weeks since prior radiotherapy and recovered No concurrent systemic radiotherapy No concurrent surgery At least 3 weeks since other prior investigational drugs (including analgesics or antiemetics) and recovered No other concurrent investigational drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis J. Giles, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

6-Hydroxymethylacylfulvene in Treating Patients With Refractory Myelodysplastic Syndrome, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Blastic Phase Chronic Myelogenous Leukemia

We'll reach out to this number within 24 hrs