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

NCT ID: NCT00354276

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-05-31

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.

Detailed Description

OBJECTIVES:

Primary

• Determine the complete response rate in older patients with poor-risk, de novo acute myeloid leukemia treated with VNP40101M as induction therapy followed by cytarabine as consolidation therapy.

Secondary

• Determine the probability of overall survival, leukemia-free survival, and progression-free survival of patients treated with this regimen.
• Determine the safety of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

• Induction therapy: Patients receive VNP40101M IV over 60 minutes on day 1 (course 1). Patients without evidence of disease progression who have responding but residual disease receive a second course of VNP40101M once between days 35-60. Patients achieving complete response or partial response after induction therapy proceed to consolidation therapy.
• Consolidation therapy: Beginning between days 45-90, patients receive cytarabine IV continuously over 5 days (course 1). Patients may receive a second course of cytarabine at the discretion of the investigator.

After completion of study treatment, patients are followed periodically for up to 36 months.

PROJECTED ACCRUAL: A total of 85 patients will be accrued for this study.

Conditions

Leukemia

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

cytarabine

Intervention Type: DRUG

laromustine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vion Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

Bonny L. Johnson, RN, MSN

Role:

Vion Pharmaceuticals

Locations

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, United States

Hopital Haut Leveque

Pessac, , France

University Hospital of Wales

Cardiff, Wales, United Kingdom

Countries

United States; France; United Kingdom

Other Identifiers

VION-CLI-043

Identifier Type: -

Identifier Source: secondary_id

EUDRACT-2006-001853-89

Identifier Type: -

Identifier Source: secondary_id

CDR0000492755

Identifier Type: -

Identifier Source: org_study_id

NCT00389623

Identifier Type: -

Identifier Source: nct_alias