VNP40101M in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndrome
This study has been completed.
Sponsor:
Vion Pharmaceuticals
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00049686
First received: November 12, 2002
Last updated: May 12, 2011
Last verified: September 2003
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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 Neoplasms |
Drug: laromustine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Trial Of VNP40101M, A Novel Alkylating Agent, For Patients With Hematologic Malignancies |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | April 2002 |
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:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00049686 History of Changes |
| Other Study ID Numbers: | CDR0000258354, VION-CLI-029, MDA-DM-02202 |
| Study First Received: | November 12, 2002 |
| Last Updated: | May 12, 2011 |
| 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, BCR-ABL1 negative myelodysplastic/myeloproliferative neoplasm, unclassifiable |
Additional relevant MeSH terms:
|
Neoplasms Leukemia Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases Neoplasms by Histologic Type |
Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Alkylating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013