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


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Mario Sznol, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vion Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000258354

NCT ID:

NCT00049686

Start Date:

April 2002

Completion Date:

Related Keywords:

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

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009