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

PHASE1CompletedINTERVENTIONAL
Enrollment

29

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

August 31, 2013

Study Completion Date

June 30, 2014

Conditions
Melanoma
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.

Trial Locations (3)

27710

Duke University Medical Center, Durham

33612

Moffitt Cancer Center, Tampa

77030

MD Anderson Cancer Center, Houston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

Duke University

OTHER

collaborator

M.D. Anderson Cancer Center

OTHER

collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

lead

Douglas Tyler

OTHER