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Evaluate Safety/Tolerability Intra-Arterial Temozolomide in Patients w/Extremity Melanoma by Isolated Limb Infusion

NCT01127594 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2015-03-09

No results posted yet for this study

Summary

The purpose of this study is to determine the safety profile of intra-arterial temozolomide administration during Isolated Limb Infusion (ILI) by defining the dose limiting toxicities associated with this treatment. This study also aims to determine the maximum tolerated dose of intra-arterial administration of temozolomide during ILI that will be used in a phase II trial.

Conditions

Interventions

DRUG

Temozolomide

Dose level selection will proceed according to the modified Accelerated Titration Design. The starting dose will be TMZ 200mg/m2 x 0.09 BSA for the upper extremity and 200mg/m2 x 0.18 BSA for the lower extremity. We will enroll one-patient cohorts with dose doubling between cohorts until 1st occurrence of a ≥ CTC (Common Terminology Criteria) grade 2 adverse event. At that time, the present cohort and all future cohorts will be extended to enroll 3 to 6 patients.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Duke University

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • H. Lee Moffitt Cancer Center and Research Institute

    collaborator OTHER

  • Douglas Tyler

    lead OTHER

Principal Investigators

  • Douglas S Tyler, MD · Duke University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-08-31
Completion
2014-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT01127594 on ClinicalTrials.gov