- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00003997
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)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- University of Texas - MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Francis J. Giles, MD, M.D. Anderson Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Myeloproliferative Disorders
- Neoplastic Processes
- Precancerous Conditions
- Cell Transformation, Neoplastic
- Carcinogenesis
- Syndrome
- Myelodysplastic Syndromes
- Leukemia
- Leukemia, Myeloid
- Preleukemia
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Blast Crisis
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Irofulven
Other Study ID Numbers
- NCI-2012-02309
- MDA-ID-99060
- NCI-T99-0043
- CDR0000067207 (Registry Identifier: PDQ (Physician Data Query))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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