Temozolomide and VNP40101M in Treating Patients With Relapsed or Refractory Leukemias

NCT00098436 | Completed Phase 1

• 3 other identifiers: VION-CLI-036CDR0000405825CWRU-050419
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 4

Brief Summary

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

Leukemia

Keywords

recurrent adult acute myeloid leukemia; recurrent adult acute lymphoblastic leukemia; blastic phase chronic myelogenous leukemia; relapsing chronic myelogenous leukemia; secondary acute myeloid leukemia; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22)

Interventions

laromustine DRUG

temozolomide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vion Pharmaceuticals: lead

Study Sites (4)

American Health Network - North Illinois Street

Indianapolis, Indiana, 46202, United States

Location

Duke Comprehensive Cancer Center

Durham, North Carolina, 27710, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Rizzieri 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 RESULT

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Blast Crisis; Congenital Abnormalities

Interventions

laromustine; Temozolomide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Cell Transformation, Neoplastic; Carcinogenesis; Neoplastic Processes; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bonny L. Johnson, RN, MSN

  Vion Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 7, 2004
• First Posted: December 8, 2004
• Study Start: September 1, 2004
• Primary Completion: October 1, 2006
• Study Completion: August 1, 2008
• Last Updated: July 18, 2013

Record last verified: 2008-08

Locations

US (4)