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A Phase I Study Of VNP40101M And Cytarabine For Patients With Hematologic Malignancies


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

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Trial Information

A Phase I Study Of VNP40101M And Cytarabine For Patients With Hematologic Malignancies


OBJECTIVES:

- Determine the maximum tolerated dose of VP40101M when administered with cytarabine in
patients with hematologic malignancies.

- Determine the toxic effects of this regimen in these patients.

OUTLINE: This is an open-label, dose-escalation study of VNP40101M.

Patients receive cytarabine IV over 24 hours on days 1-4 for patients under 65 years of age
OR on days 1-3 for patients 65 years of age and over. Patients also receive VNP40101M IV
over 15-60 minutes on day 2. Treatment repeats every 4 weeks for up to 3 courses (in
patients with responding disease) in the absence of disease progression or unacceptable
toxicity. Patients with a continued response may receive additional courses at the
discretion of the investigator.

Cohorts of 3-6 patients receive escalating doses of VNP40101M until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
of 6 patients experience dose-limiting toxicity. Up to 10 patients may receive treatment at
the MTD.

PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of leukemia or myelodysplastic syndromes (MDS) meeting criteria for 1 of
the following:

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

- Acute myeloid leukemia

- Acute lymphocytic leukemia

- Chronic myelogenous leukemia

- In blast crisis

- Untreated leukemia and standard therapy is refused

- Any of the following poor-risk MDS:

- Refractory anemia with excess blasts (RAEB)

- RAEB in transformation

- Chronic myelomonocytic leukemia

- CNS leukemia allowed

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

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

- ALT or AST no greater than 3 times ULN

- Chronic hepatitis allowed

Renal

- Creatinine no greater than 2.0 mg/dL

Cardiovascular

- No active heart disease

- No myocardial infarction within the past 3 months

- No symptomatic coronary artery disease

- No arrhythmias uncontrolled by medication

- No uncontrolled congestive heart failure

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No persistent chronic toxic effects from prior chemotherapy greater than grade 1

- No uncontrolled active infection

- Infections under control and under active treatment with antibiotics allowed

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- At least 48 hours since prior hydroxyurea

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Other

- At least 2 weeks since prior myelosuppressive cytotoxic agents (in the absence of
rapidly progressing disease)

- 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:

CDR0000334879

NCT ID:

NCT00070538

Start Date:

June 2003

Completion Date:

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • recurrent adult acute lymphoblastic leukemia
  • blastic phase chronic myelogenous leukemia
  • relapsing chronic myelogenous leukemia
  • chronic myelomonocytic leukemia
  • refractory anemia with excess blasts in transformation
  • refractory anemia with excess blasts
  • recurrent adult acute myeloid leukemia
  • untreated adult acute myeloid leukemia
  • untreated adult acute lymphoblastic leukemia
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Hematologic Neoplasms

Name

Location
University of Texas - MD Anderson Cancer Center Houston, Texas  77030-4009