Clinical trial · Interventional
BMS-214662 in Treating Patients With Acute Leukemia, Myelodysplastic Syndrome, or Chronic Myeloid Leukemia
Phase I Study of Farnesyl Transferase Inhibitor BMS-214662 (NSC 710086) in Acute Leukemias, Myelodysplastic Syndromes (RAEB and RAEB-T) and Chronic Myeloid Leukemia in Blast Phase
NCT00006213CI-TRIAL-00009034completedPhase 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)
Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Phase I trial to study the effectiveness of BMS-214662 in treating patients who have acute leukemia, myelodysplastic syndrome, or chronic myeloid leukemia in blast phase
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Promyelocytic Leukemia (M3) | Adult Acute Promyelocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Blastic Phase Chronic Myelogenous Leukemia | Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Childhood Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.85 |
| Previously Treated Myelodysplastic Syndromes | Myelodysplastic Syndrome | CURATED_BROADER | 0.78 |
| Recurrent Adult Acute Lymphoblastic Leukemia | Adult Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Recurrent Adult Acute Myeloid Leukemia | Adult Acute Myeloid Leukemia | CURATED_BROADER | 0.78 |
| Recurrent Childhood Acute Lymphoblastic Leukemia | Childhood Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
| Recurrent Childhood Acute Myeloid Leukemia |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BMS-214662 | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| pharmacological study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (BMS-214662)
- description
- Patients receive BMS-214662 IV over 1 hour weekly for 4 weeks. Treatment continues every 4 weeks for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression.
- interventionNames
- Drug: BMS-214662
- Other: pharmacological study
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- MTD defined as the dose preceding that at which 2 of 6 patients experience DLT assessed using NCI CTC version 2.0
- timeFrame
- 4 weeks
- description
- Non-parametric tests will be used to study the relationship between baseline and post-therapy values at different dose levels and times.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion Criteria:
* Patients must have:
* AML, ALL, or high-risk MDS (RAEB or RAEB-t) that has:
* Not responded (no CR) to initial induction chemotherapy, or
* Recurred after an initial CR of \< 1 year, or
* Recurred after an initial CR of \> 1 year and failed to respond to an initial reinduction attempt, or
* Recurred more than once, or
* Chronic myeloid leukemia in myeloid blast phase
* Patients with CML blast phase may receive BMS-214662 as their first therapy for blast phase or after failing other treatments for blast phase
* Patients with refractory or relapsed acute promyelocytic leukemia are eligible provided they have failed an ATRA-containing regimen
* Performance status of =\< 0-2
* Signed informed consent indicating that patients are aware of the investigational nature of this study in keeping with the policies of the hospital
* Patients must have been off chemotherapy for the 4 weeks prior to entering this study and recovered from the toxic effects of that therapy; patients with evidence of rapidly progressive disease (i.e., absolute peripheral blood blast count \>= 5 x 10\^9/L and increasing by \>= 1 x 10\^9/L/24 hours) may receive treatment before 4 weeks from the previous treatment providing they have recovered from all toxic effects of that therapy; use of hydroxyurea on patients with rapidly proliferative disease is allowed up to 24 hours prior to the start of therapy
* Bilirubin =\< 1.5 mg/dL
* Creatinine =\< 1.5 mg/dL or creatinine clearance \>= 60 mL/hr
* Patients who are likely to benefit from allogeneic bone marrow transplantation (i.e., age \< 60 years of physiological age with histocompatible donor) should be excluded from this study unless such therapy is not feasible
Exclusion Criteria:
* Pregnant and nursing females will be excluded; patients of childbearing potential should practice effective methods of contraception
* Patients with prolonged QTc interval on EKG are excludedReferences
Publications (0)
Data not yet available
No reference posted for this study.