- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00070538
VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies
A Phase I Study Of VNP40101M And Cytarabine For Patients With Hematologic Malignancies
RATIONALE: Drugs used in chemotherapy, such as VNP40101M and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of combining VNP40101M with cytarabine in treating patients who have hematologic malignancies, including myelodysplastic syndrome or relapsed, refractory, or untreated leukemia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Texas
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Houston, Texas, United States, 77030-4095
- University of Texas - MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Giles F, Verstovsek S, Thomas D, Gerson S, Cortes J, Faderl S, Ferrajoli A, Ravandi F, Kornblau S, Garcia-Manero G, Jabbour E, O'Brien S, Karsten V, Cahill A, Yee K, Albitar M, Sznol M, Kantarjian H. Phase I study of cloretazine (VNP40101M), a novel sulfonylhydrazine alkylating agent, combined with cytarabine in patients with refractory leukemia. Clin Cancer Res. 2005 Nov 1;11(21):7817-24. doi: 10.1158/1078-0432.CCR-05-1070.
- Giles FJ, Verstovsek S, Cortes J, et al.: Phase I study of VNP40101M (101M) and AraC in patients (pts) with refractory leukemia. [Abstract] J Clin Oncol 22 (14 Suppl): A-6617, 586s, 2004.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- refractory anemia with excess blasts
- refractory anemia with excess blasts in transformation
- chronic myelomonocytic leukemia
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- adult acute myeloid leukemia with inv(16)(p13;q22)
- adult acute myeloid leukemia with t(15;17)(q22;q12)
- adult acute myeloid leukemia with t(16;16)(p13;q22)
- adult acute myeloid leukemia with t(8;21)(q22;q22)
- recurrent adult acute myeloid leukemia
- untreated adult acute myeloid leukemia
- blastic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- recurrent adult acute lymphoblastic leukemia
- untreated adult acute lymphoblastic leukemia
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Precancerous Conditions
- Syndrome
- Myelodysplastic Syndromes
- Hematologic Neoplasms
- Leukemia
- Preleukemia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Cytarabine
Other Study ID Numbers
- VION-CLI-034
- CDR0000334879 (Registry Identifier: PDQ (Physician Data Query))
- MDA-2003-0326
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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