VNP40101M in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndrome

Leukemia Clinical Trial

Official title:

A Phase I Trial Of VNP40101M, A Novel Alkylating Agent, For Patients With Hematologic Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00049686
• Other study ID #: VION-CLI-029
• Secondary ID: CDR0000258354MDA
• Status: Completed
• Phase: Phase 1
• First received: November 12, 2002
• Last updated: July 17, 2013
• Start date: April 2002
• Est. completion date: January 2008

Study information

• Verified date: September 2003
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of VNP40101M in treating patients who have relapsed or refractory leukemia or myelodysplastic syndrome.

Description:

OBJECTIVES:

• Determine the toxic effects of VNP40101M in patients with relapsed or refractory leukemia or poor-risk myelodysplastic syndromes.

• Determine the maximum tolerated dose of this drug in these patients.

• Determine the pharmacokinetics of this drug in these patients.

• Determine the antitumor effects of this drug in these patients.

OUTLINE: Patients receive VNP40101M IV over 15 minutes once every 4 weeks.

PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Relapsed or refractory leukemia for which no standard therapy is anticipated to result in a durable remission OR

• Poor-risk myelodysplastic syndromes

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• AST and ALT no greater than 3 times ULN

Renal

• Creatinine no greater than 2.0 mg/dL

Cardiovascular

• No myocardial infarction within the past 3 months

• No symptomatic coronary artery disease

• No uncontrolled arrhythmia

• No uncontrolled congestive heart failure

Other

• No uncontrolled active infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Prior biologic therapy allowed

Chemotherapy

• At least 2 weeks since prior myelosuppressive cytotoxic chemotherapy in the absence of rapidly progressing disease

• At least 48 hours since prior hydroxyurea

Endocrine therapy

• Not specified

Radiotherapy

• Prior radiotherapy allowed

Surgery

• Not specified

Other

• No other concurrent standard or investigational treatment for leukemia

• No concurrent disulfiram

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Preleukemia
• Syndrome

Intervention

Drug:
• laromustine

Locations

Country	Name	City	State
United States	University of Texas - MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Vion Pharmaceuticals

Country where clinical trial is conducted

United States,