VNP40101M in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndrome

Back to results

Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

laromustine

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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

Eligibility Criteria

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

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

Sites / Locations

University of Texas - MD Anderson Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00049686

First Posted

November 12, 2002

Last Updated

July 17, 2013

Sponsor

Vion Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00049686

Brief Title

VNP40101M in Treating Patients With Relapsed or Refractory Leukemia or Myelodysplastic Syndrome

Official Title

A Phase I Trial Of VNP40101M, A Novel Alkylating Agent, For Patients With Hematologic Malignancies

Study Type

Interventional

2. Study Status

Record Verification Date

September 2003

Overall Recruitment Status

Completed

Study Start Date

April 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

January 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Vion Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

Keywords

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

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)

laromustine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

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

Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial