VNP40101M in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndrome - Full Text View

Sponsor:	Vion Pharmaceuticals
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00049686

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 Diseases	Drug: laromustine	Phase I

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Cloretazine

U.S. FDA Resources

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

Study Start Date:

April 2002

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

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000258354, VION-CLI-029, MDA-DM-02202
Study First Received:	November 12, 2002
Last Updated:	December 13, 2008
ClinicalTrials.gov Identifier:	NCT00049686 History of Changes
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
myelodysplastic/myeloproliferative disease, unclassifiable

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Disease
Precancerous Conditions
Hematologic Diseases
Myelodysplastic Syndromes
Myeloproliferative Disorders
Leukemia

Preleukemia
Neoplasms
Pathologic Processes
Syndrome
Myelodysplastic-Myeloproliferative Diseases
Bone Marrow Diseases

ClinicalTrials.gov processed this record on November 27, 2009