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Cloretazine (VNP40101M) With Hematopoietic Cell Transplantation for Hematologic Malignancies

NCT00521859 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2012-07-31

No results posted yet for this study

Summary

Primary:

Define the maximal tolerated dose (MTD) of VNP40401M when given with hematopoietic cell transplantation (HCT)

Secondary:

* Describe the change in pharmacokinetic (PK) parameters with increasing doses of drug.
* Describe and estimate the frequency of \> Grade 3 non-hematologic/non-infectious toxicities at the MTD.
* Report the efficacy of the regimen.
* Evaluate the rate of engraftment for the regimen.

Conditions

Interventions

DRUG

Cloretazine

800 mg/m\^2 by vein daily

DRUG

Fludarabine

25 mg/m\^2 by vein daily x 5 Days

Sponsors & Collaborators

  • Vion Pharmaceuticals

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Roy B. Jones, MD, PhD · UT MD Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00521859 on ClinicalTrials.gov