Clinical trial · Interventional
VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies
A Phase I Study Of VNP40101M And Cytarabine For Patients With Hematologic Malignancies
NCT00070538CI-TRIAL-00011427completedPhase 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, such as VNP40101M and cytarabine, 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 combining VNP40101M with cytarabine in treating patients who have hematologic malignancies, including myelodysplastic syndrome or relapsed, refractory, or untreated 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 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cytarabine | Drug | Cytarabine | ALIAS |
| laromustine | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of leukemia or myelodysplastic syndromes (MDS) meeting criteria for 1 of the following:
* Relapsed or refractory leukemia for which there is no standard therapy anticipated to result in a durable remission
* Acute myeloid leukemia
* Acute lymphocytic leukemia
* Chronic myelogenous leukemia
* In blast crisis
* Untreated leukemia and standard therapy is refused
* Any of the following poor-risk MDS:
* Refractory anemia with excess blasts (RAEB)
* RAEB in transformation
* Chronic myelomonocytic leukemia
* CNS leukemia allowed
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* ALT or AST no greater than 3 times ULN
* Chronic hepatitis allowed
Renal
* Creatinine no greater than 2.0 mg/dL
Cardiovascular
* No active heart disease
* No myocardial infarction within the past 3 months
* No symptomatic coronary artery disease
* No arrhythmias uncontrolled by medication
* No uncontrolled congestive heart failure
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No persistent chronic toxic effects from prior chemotherapy greater than grade 1
* No uncontrolled active infection
* Infections under control and under active treatment with antibiotics allowed
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* At least 48 hours since prior hydroxyurea
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* At least 2 weeks since prior myelosuppressive cytotoxic agents (in the absence of rapidly progressing disease)
* No other concurrent standard or investigational treatment for leukemia
* No concurrent disulfiramReferences
Publications (2)
- RESULTGiles F, Verstovsek S, Thomas D, Gerson S, Cortes J, Faderl S, Ferrajoli A, Ravandi F, Kornblau S, Garcia-Manero G, Jabbour E, O'Brien S, Karsten V, Cahill A, Yee K, Albitar M, Sznol M, Kantarjian H. Phase I study of cloretazine (VNP40101M), a novel sulfonylhydrazine alkylating agent, combined with cytarabine in patients with refractory leukemia. Clin Cancer Res. 2005 Nov 1;11(21):7817-24. doi: 10.1158/1078-0432.CCR-05-1070. PMID 16278404
- RESULTGiles FJ, Verstovsek S, Cortes J, et al.: Phase I study of VNP40101M (101M) and AraC in patients (pts) with refractory leukemia. [Abstract] J Clin Oncol 22 (14 Suppl): A-6617, 586s, 2004.