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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003997 |
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 6-hydroxymethylacylfulvene in treating patients who have refractory myelodysplastic syndrome, acute myeloid leukemia, acute lymphocytic leukemia, or blastic phase chronic myelogenous leukemia.
Condition | Intervention | Phase |
Leukemia Myelodysplastic Syndromes |
Drug: irofulven |
Phase I |
MedlinePlus related topics: | Cancer Leukemia, Adult Acute Leukemia, Adult Chronic |
ChemIDplus related topics: | 6-(Hydroxymethyl)acylfulvene |
Study Type: | Interventional |
Study Design: | Treatment |
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 Start Date: | July 1999 |
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.
PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study at a rate of 2-4 patients per month.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No active congestive heart failure No uncontrolled angina No myocardial infarction within past 6 months Other: 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: Biologic therapy: At least 2 weeks since prior biologic therapy and recovered No concurrent systemic anticancer biologic therapy Chemotherapy: At least 2 weeks since other prior chemotherapy and recovered Concurrent hydroxyurea allowed if needed to control blast counts No concurrent systemic anticancer chemotherapy Endocrine therapy: At least 2 weeks since prior endocrine therapy and recovered Concurrent corticosteroids allowed if needed to control blast counts Radiotherapy: At least 2 weeks since prior radiotherapy and recovered No concurrent systemic radiotherapy Surgery: No concurrent surgery Other: At least 3 weeks since other prior investigational drugs (including analgesics or antiemetics) and recovered No other concurrent investigational drugs
United States, Texas | |||||
University of Texas - MD Anderson Cancer Center | |||||
Houston, Texas, United States, 77030 |
M.D. Anderson Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Francis J. Giles, MD | M.D. Anderson Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000067207, MDA-ID-99060, NCI-T99-0043 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003997 |
Health Authority: | United States: Federal Government |
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