Clinical trial · Interventional
Temozolomide and VNP40101M in Treating Patients With Relapsed or Refractory Leukemias
A Phase I Study Of Cloretazine™ (VNP40101M) And Temozolomide In Patients With Hematologic Malignancies
- 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 temozolomide and VNP40101M, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Temozolomide may also help VNP40101M kill more cancer cells by making cancer cells more sensitive to the drug. Giving temozolomide together with VNP40101M may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best dose of temozolomide and VNP40101M in treating patients with relapsed or refractory leukemias.
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 |
|---|---|---|---|
| laromustine | Drug | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of 1 of the following: * Acute myeloid leukemia * Acute lymphoblastic leukemia * Chronic myelogenous leukemia in blast crisis * Relapsed or refractory disease * No known standard therapy that is anticipated to result in a durable remission exists * CNS leukemia allowed PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * ALT or AST ≤ 3 times ULN * Chronic hepatitis allowed Renal * Creatinine ≤ 2.0 mg/dL Cardiovascular * No active heart disease, including any of the following: * Myocardial infarction within the past 3 months * Symptomatic coronary artery disease * Arrhythmias not controlled by medication * Uncontrolled congestive heart failure Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation * No uncontrolled active infection PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Concurrent hydroxyurea allowed within the first 10 days of study drug administration for control of elevated blast levels or platelet counts * Maximum hydroxyurea dose 5 g daily * No persistent chronic toxic effects from prior chemotherapy \> grade 1 Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * Recovered from all prior therapy * At least 2 weeks since prior myelosuppressive cytotoxic agents (in the absence of rapidly progressive disease) * No more than 2 leukapheresis procedures within the first 10 days of study drug administration for control of elevated blast levels or platelet counts * No concurrent disulfiram * No other concurrent anticancer drugs * No other concurrent standard or investigational treatment for leukemia
References
Publications (1)
- RESULTRizzieri D, LoRusso S, Tse W, Khan K, Advani A, Moore J, Karsten V, Cahill A, Gerson SL. Phase I study of temozolomide and laromustine (VNP40101M) in patients with relapsed or refractory leukemia. Clin Lymphoma Myeloma Leuk. 2010 Jun;10(3):211-6. doi: 10.3816/CLML.2010.n.033. PMID 20511167