Clinical trial · Interventional
Combination Chemotherapy in Treating Patients With Chronic Myelogenous Leukemia or Recurrent Acute Leukemia
PHASE I STUDY OF CONTINUOUS INFUSION CARBOPLATIN AND TOPOTECAN IN THE TREATMENT OF RELAPSED ACUTE LEUKEMIA AND BLAST CRISIS CHRONIC MYELOGENOUS LEUKEMIA
NCT00002693CI-TRIAL-00005309completedPhase 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. Combining more than one drug may kill more cancer cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy with carboplatin and topotecan in treating patients with chronic myelogenous leukemia or recurrent acute leukemia.
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 |
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| filgrastim | Biological | Filgrastim | ALIAS |
| topotecan hydrochloride | Drug | Topotecan | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Acute lymphocytic or myeloid leukemia (ALL or AML) in 1 of the following categories:
* Failed to achieve a complete response (CR) with initial induction regimen
* First relapse within 1 year of initial CR
* Failed re-induction therapy at first relapse
* Second relapse after no more than 2 different induction regimens
* Relapse defined as more than 10% blasts in marrow or circulating blasts in peripheral blood and either:
* Symptoms of recurrence (e.g., B symptoms)
* Evidence of impending marrow failure (i.e., cytopenias) OR
* Chronic myelogenous leukemia in accelerated or blastic phase after no more than 1 prior induction regimen
* No HLA-identical sibling marrow donor or patient ineligible for allogeneic marrow transplantation
* No clinical symptoms of CNS leukemia
* Patients with history of CNS leukemia must have pretreatment lumbar puncture demonstrating absence of active CNS disease
* No active CNS disease
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-2
Life expectancy:
* At least 4 weeks
Hematologic:
* Not applicable
Hepatic:
* Bilirubin less than 2 mg/dL
Renal:
* Creatinine no greater than 1.5 mg/dL
Cardiovascular:
* No congestive heart failure
* No poorly controlled arrhythmia
* No myocardial infarction within the past 3 months
Other:
* No active infection
* No other serious medical condition that would prevent compliance
* Not pregnant or nursing
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* See Disease Characteristics
* At least 24 hours since prior hydroxyurea for impending leukostasis
* No concurrent hydroxyurea glucocorticoids
* Recovered from prior chemotherapy
Endocrine therapy:
* At least 24 hours since prior glucocorticoids for impending leukostasis
* At least 7 days since prior amphotericin or aminoglycosides
* No concurrent glucocorticoids
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No concurrent aminoglycoside antibioticsReferences
Publications (1)
- RESULTKaufmann S, Letendre L, Litzow M, et al.: Phase I study of continuous infusion (CI) topotecan (TPT) and carboplatin (CBDCA) for relapsed or refractory acute leukemia. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A107, 1998.