A Phase I Trial Of VNP40101M, A Novel Alkylating Agent, For Patients With Hematologic Malignancies
18 Years
N/A
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
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 Center | Houston, Texas 77030-4009 |
