Clinical trial · Interventional
Chemotherapy in Treating Patients Who Have Hematologic Cancer
A Phase I Study of Intravenous DX-8951f in Patients With Advanced Myelodysplastic Syndromes, Refractory Acute Leukemia, Refractory or Transformed Chronic Lymphocytic Leukemia, and Chronic Myelogenous Leukemia in Blastic Phase
NCT00004047CI-TRIAL-00006918completedPhase 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)
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 DX-8951f in treating patients who have hematologic cancer.
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 |
|---|---|---|---|
| exatecan mesylate | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
DISEASE CHARACTERISTICS: One of the following hematologic malignancies: Advanced myelodysplastic syndromes Refractory anemia with excess blasts Refractory anemia with excess blasts in transformation Chronic myelomonocytic leukemia Refractory acute myeloid leukemia (AML) First salvage with primary refractory AML or first complete response (CR) no greater than 12 months in duration or at least second salvage therapy Once maximum tolerated dose is determined, intermediate AML prognosis (first CR duration greater than 12 months but less than 24 months) eligible Refractory acute lymphocytic leukemia Refractory or transformed chronic lymphocytic leukemia Chronic myelogenous leukemia in blastic phase No CNS disease PATIENT CHARACTERISTICS: Age: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: No specified Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT or SGPT no greater than 2.0 times upper limit of normal Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled angina No myocardial infarction within the past 6 months Other: Not pregnant or nursing Fertile patients must use effective contraception Negative pregnancy test No concurrent grade 4 infection No psychiatric disorder or mental disability No other life threatening illness PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: At least 30 days since prior cytotoxic therapy and recovered No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy to greater than 25% of skeleton Surgery: No concurrent surgery Other: At least 3 weeks since prior investigational drugs (including analgesics or antiemetics) Recovered from toxic effects of any prior therapy
References
Publications (1)
- RESULTGiles FJ, Cortes JE, Thomas DA, Garcia-Manero G, Faderl S, Jeha S, De Jager RL, Kantarjian HM. Phase I and pharmacokinetic study of DX-8951f (exatecan mesylate), a hexacyclic camptothecin, on a daily-times-five schedule in patients with advanced leukemia. Clin Cancer Res. 2002 Jul;8(7):2134-41. PMID 12114413