VNP40101M Followed by Cytarabine in Treating Older Patients With Acute Myeloid Leukemia

NCT00354276 | Unknown Phase 2

• 3 other identifiers: CDR0000492755VION-CLI-043EUDRACT-2006-001853-89
• Study Type: interventional
• Target: 85
• Locations: 3 countries
• Sites: 3

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as VNP40101M and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving VNP40101M followed by cytarabine may kill more cancer cells. PURPOSE: This phase II trial is studying how well VNP40101M followed by cytarabine works in treating older patients with acute myeloid leukemia.

Conditions

Leukemia

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with t(16;16)(p13;q22); untreated adult acute myeloid leukemia; adult acute myelomonocytic leukemia (M4); adult acute monocytic leukemia (M5b); adult erythroleukemia (M6a); adult pure erythroid leukemia (M6b); adult acute monoblastic leukemia (M5a); adult acute megakaryoblastic leukemia (M7); adult acute basophilic leukemia; adult acute myeloblastic leukemia without maturation (M1); adult acute myeloblastic leukemia with maturation (M2); adult acute eosinophilic leukemia; adult acute minimally differentiated myeloid leukemia (M0)

Outcome Measures

Primary Outcomes (1)

• Complete response rate

Secondary Outcomes (1)

• Leukemia-free survival

Interventions

cytarabine DRUG

laromustine DRUG

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed de novo acute myeloid leukemia (AML) * No acute promyelocytic leukemia \[t(15;17)\] * No favorable cytogenetics, including t(15;17), t(8;21), or inv 16 * No secondary AML, defined as having a history of an antecedent hematologic disorder (myelodysplastic syndromes \[MDS\] or myeloproliferative disease), or history of prior chemotherapy or radiation for a disease other than AML * Must have ≥ 1 of the following poor-risk features: * Any of the following unfavorable cytogenetics: * Del (5q)/-5q * -7/del(7q) * Abnormal 3q, 9q, 11q, 20q, 21q, or 17p * t(6;9) * t(9;22) * Trisomy 8 * Complex karyotypes (≥ 3 unrelated abnormalities) * At least 70 years of age * ECOG performance status (PS) of 2 * Cardiac dysfunction\* that would limit the use of anthracycline therapy, as defined by any of the following: * Ejection fraction ≤ 50% * History of significant coronary artery disease, defined as ≥ 1 vessel stenosis requiring medical treatment, stent placement, or surgical bypass graft * History of congestive heart failure or myocardial infarction * Significant arrhythmia, including any of the following: * Atrial flutter (excluding atrial fibrillation) * Sick sinus syndrome * Ventricular arrhythmia * Heart valve disease * Mitral valve prolapse allowed * Other heart disease, at the discretion of the principal investigator * Pulmonary dysfunction not related to AML, defined by 1 of the following: * DLCO and/or FEV\_1 \< 80% and ≥ 50% normal range * Dyspnea on slight activity or at rest * Requires oxygen * Hepatic dysfunction related to chronic hepatitis or liver cirrhosis * Other organ dysfunction or comorbidity that precludes standard cytotoxic induction treatment (e.g., "3+7"), at the discretion of the principal investigator NOTE: \*Patients with a history of heart disease as defined above must be on appropriate medication and have their disease under control * No known CNS disease PATIENT CHARACTERISTICS: * ECOG PS 0-2 * AST and ALT ≤ 5 times upper limit of normal * Bilirubin ≤ 2.0 mg/dL * Creatinine ≤ 2.0 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after completion of study treatment * No active, uncontrolled infection * Patients with an infection who are under active treatment with antibiotics and whose infections are controlled are eligible * Chronic hepatitis allowed * No clinical evidence of ongoing second malignancy unrelated to AML or MDS * No evidence of left bundle branch block on screening ECG * No obligate use of cardiac pacemaker or atrial fibrillation PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 24 hours since prior metronidazole * No prior low-dose, single-agent, cytotoxic chemotherapy (e.g., cytarabine, decitabine, or azacitidine) * No concurrent disulfiram * No other concurrent standard or investigational therapy for AML except for the following: * Concurrent hydroxyurea to control rising white blood cell counts * Dosage must be 4-6 grams daily for up to 4 days * Concurrent leukapheresis to control blast cell counts * Must be completed within the first 5 days of study therapy * No more than 2 procedures per day or 4 procedures total * Investigational supportive care agents (e.g., antimicrobials or antifungal agents), at the discretion of the protocol sponsor

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 (3)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

Hopital Haut Leveque

Pessac, 33604, France

Location

University Hospital of Wales

Cardiff, Wales, CF14 4XW, United Kingdom

Location

MeSH Terms

Conditions

Leukemia; Congenital Abnormalities; Leukemia, Myelomonocytic, Acute; Leukemia, Monocytic, Acute; Leukemia, Erythroblastic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Basophilic, Acute; Leukemia, Myeloid, Acute; Leukemia, Eosinophilic, Acute

Interventions

Cytarabine; laromustine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Bonny L. Johnson, RN, MSN

  Vion Pharmaceuticals

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 19, 2006
• First Posted: July 20, 2006
• Study Start: May 1, 2006
• Primary Completion: December 1, 2008
• Last Updated: January 10, 2014

Record last verified: 2009-05

Locations

US (1); FR (1); GB (1)