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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00049686

Enrollment

Unknown

Registered

2003-01-27

Start date

2002-04-30

Completion date

2008-01-31

Last updated

2013-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

Keywords

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

Brief 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.

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.

Interventions

DRUGlaromustine

Study design

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026