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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003997
First received: November 1, 1999
Last updated: February 7, 2013
Last verified: January 2001

November 1, 1999
February 7, 2013
July 1999
October 2000   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003997 on ClinicalTrials.gov Archive Site
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6-Hydroxymethylacylfulvene in Treating Patients With Refractory Myelodysplastic Syndrome, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Blastic Phase Chronic Myelogenous Leukemia
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)

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.

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.

Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Leukemia
  • Myelodysplastic Syndromes
Drug: irofulven
Experimental: Arm I
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: Drug: irofulven
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
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October 2000   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003997
NCI-2012-02309, MDA-ID-99060, NCI-T99-0043, CDR0000067207
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Study Chair: Francis J. Giles, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
January 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP