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VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies

Primary Purpose

Leukemia, Myelodysplastic Syndromes

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
cytarabine
laromustine
Sponsored by
Vion Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas - MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 3, 2003
Last Updated
July 17, 2013
Sponsor
Vion Pharmaceuticals
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00070538
Brief Title
VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies
Official Title
A Phase I Study Of VNP40101M And Cytarabine For Patients With Hematologic Malignancies
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Vion Pharmaceuticals
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelodysplastic Syndromes
Keywords
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cytarabine
Intervention Type
Drug
Intervention Name(s)
laromustine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Sznol, MD
Organizational Affiliation
Vion Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
University of Texas - MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4095
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16278404
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

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VNP40101M and Cytarabine in Treating Patients With Hematologic Malignancies

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