NCT00049686

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2002

Typical duration for phase_1 leukemia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2002

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

July 18, 2013

Status Verified

September 1, 2003

First QC Date

November 12, 2002

Last Update Submit

July 17, 2013

Conditions

LeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasms

Keywords

acute undifferentiated leukemiachronic myelomonocytic leukemiapreviously treated myelodysplastic syndromesprolymphocytic leukemiarecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarefractory chronic lymphocytic leukemiarefractory anemia with excess blastsrefractory cytopenia with multilineage dysplasiarefractory hairy cell leukemiarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiasecondary myelodysplastic syndromesatypical chronic myeloid leukemia, BCR-ABL1 negativemyelodysplastic/myeloproliferative neoplasm, unclassifiable

Interventions

laromustineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4095, United States

Location

MeSH Terms

Conditions

LeukemiaMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesLeukemia, Biphenotypic, AcuteLeukemia, Myelomonocytic, ChronicLeukemia, ProlymphocyticPrecursor Cell Lymphoblastic Leukemia-LymphomaLeukemia, Myeloid, AcuteLeukemia, Lymphocytic, Chronic, B-CellAnemia, Refractory, with Excess of BlastsLeukemia, Hairy CellLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeMyeloproliferative Disorders

Interventions

laromustine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow DiseasesLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLeukemia, MyeloidChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, B-CellAnemia, RefractoryAnemia

Study Officials

  • Mario Sznol, MD

    Vion Pharmaceuticals

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 12, 2002

First Posted

January 27, 2003

Study Start

April 1, 2002

Study Completion

January 1, 2008

Last Updated

July 18, 2013

Record last verified: 2003-09

Locations

US(1)