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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00049686
First received: November 12, 2002
Last updated: July 17, 2013
Last verified: September 2003
  Purpose

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.


Condition Intervention Phase
Leukemia
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Neoplasms
Drug: laromustine
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Trial Of VNP40101M, A Novel Alkylating Agent, For Patients With Hematologic Malignancies

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2002
Study Completion Date: January 2008
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049686

Locations
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4095
Sponsors and Collaborators
Vion Pharmaceuticals
Investigators
Study Chair: Mario Sznol, MD Vion Pharmaceuticals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00049686     History of Changes
Other Study ID Numbers: VION-CLI-029, CDR0000258354, MDA-DM-02202
Study First Received: November 12, 2002
Last Updated: July 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
acute undifferentiated leukemia
chronic myelomonocytic leukemia
previously treated myelodysplastic syndromes
prolymphocytic leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
refractory chronic lymphocytic leukemia
refractory anemia with excess blasts
refractory cytopenia with multilineage dysplasia
refractory hairy cell leukemia
relapsing chronic myelogenous leukemia
secondary acute myeloid leukemia
secondary myelodysplastic syndromes
atypical chronic myeloid leukemia, BCR-ABL1 negative
myelodysplastic/myeloproliferative neoplasm, unclassifiable

Additional relevant MeSH terms:
Neoplasms
Leukemia
Myelodysplastic Syndromes
Preleukemia
Myeloproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014