Clinical trial · Interventional
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)
NCT00003997CI-TRIAL-00009373completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irofulven | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- 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.
- interventionNames
- Drug: irofulven
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.