VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies

NCT00070538 | Completed Phase 1

• 3 other identifiers: VION-CLI-034CDR0000334879MDA-2003-0326
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Leukemia; Myelodysplastic Syndromes

Keywords

recurrent adult acute lymphoblastic leukemia; blastic phase chronic myelogenous leukemia; relapsing chronic myelogenous leukemia; chronic myelomonocytic leukemia; refractory anemia with excess blasts in transformation; refractory anemia with excess blasts; recurrent adult acute myeloid leukemia; untreated adult acute myeloid leukemia; untreated adult acute lymphoblastic leukemia; de novo myelodysplastic syndromes; previously treated myelodysplastic syndromes; secondary myelodysplastic syndromes; adult acute myeloid leukemia with t(8;21)(q22;q22); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with t(15;17)(q22;q12)

Interventions

cytarabine DRUG

laromustine DRUG

Eligibility Criteria

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

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 disulfiram

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

Sponsors & Collaborators

• Vion Pharmaceuticals: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4095, United States

Location

Related Publications (2)

• Giles 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 RESULT

• Giles 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.

  RESULT

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Blast Crisis; Leukemia, Myelomonocytic, Chronic; Anemia, Refractory, with Excess of Blasts; Leukemia, Myeloid, Acute; Congenital Abnormalities

Interventions

Cytarabine; laromustine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Mario Sznol, MD

  Vion Pharmaceuticals

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: October 3, 2003
• First Posted: October 7, 2003
• Study Start: June 1, 2003
• Primary Completion: September 1, 2004
• Study Completion: January 1, 2008
• Last Updated: July 18, 2013

Record last verified: 2008-08

Locations

US (1)