Clinical trial · Interventional
Bryostatin 1 and Cytarabine in Treating Patients With Relapsed Acute Myelogenous Leukemia
Phase II Study Of Bryostatin 1 (NSC 339555) And High-Dose 1-B-D-Arabinofuranosylcytosine (HiDAC) In Patients With Refractory Leukemia
NCT00017342CI-TRIAL-00003210completedPhase 2ClinicalTrials.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 II trial to study the effectiveness of combining bryostatin 1 with cytarabine in treating patients who have relapsed primary acute myelogenous leukemia.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bryostatin 1 | Drug | — | UNRESOLVED |
| cytarabine | Drug | Cytarabine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed primary acute myelogenous leukemia (AML) in first relapse after a remission of at least 3 months duration * No secondary AML, including the following: * Therapy-related AML * AML arising from myelodysplastic syndromes or similar hematological conditions * No Philadelphia chromosome or other evidence of a (9;21) translocation * Ineligible for potentially curative allogeneic stem cell 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 times upper limit of normal (ULN) (patients with Gilbert's disease or unconjugated hyperbilirubinemia may have bilirubin no greater than 3.0 mg/dL with conjugated bilirubin no greater than 0.5 mg/dL) * AST/ALT no greater than 2 times ULN Renal: * Creatinine no greater than 1.5 times ULN Pulmonary: * No clinically significant pulmonary disease Other: * No clinically significant cytarabine-related cerebellar toxicity * No nonmalignant systemic disease that causes poor medical risk * No active, uncontrolled, serious infection * No medical condition that would preclude study participation * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * See Disease Characteristics * No prior allogeneic stem cell transplantation Chemotherapy: * At least 2 weeks since prior systemic chemotherapy (24 hours for hydroxyurea) and recovered Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * Recovered from all prior therapy
References
Publications (0)
Data not yet available
No reference posted for this study.