CLINICAL TRIAL SUMMARY

MDACC Study No:2004-0069 (clinicaltrials.gov NCT No: NCT00338377)
Title:Lymphodepletion Plus Adoptive Cell Transfer With or Without Dendritic Cell Immunization in Patients With Metastatic Melanoma
Principal Investigator:Patrick Hwu
Treatment Agent:Cyclophosphamide; Filgrastim; Fludarabine; Interleukin-2; Mesna; Ondansetron Hydrochloride; Pegfilgrastim
Study Status:Open
Study Description:The goal of the main part of this clinical research study is to learn if a
vaccine prepared from special blood cells (dendritic cells) will improve the
function of tumor fighting immune cells (T cells) specific for melanoma. These
special blood cells and immune cells will be taken from the donor's blood and
grown in the laboratory and then given back to the patient. Researchers will
also study the ability of these cells to shrink or slow the growth of the
metastatic melanoma when given with chemotherapy and Interleukin-2 (IL-2). Your
collected cells will be used to help stimulate the growth of patients' immune
cells in the laboratory.

Hide details for General InformationGeneral Information

Disease Group:Melanoma
Phase of Study:Phase II
Treatment Agents:Cyclophosphamide
Filgrastim
Fludarabine
Interleukin-2
Mesna
Ondansetron Hydrochloride
Pegfilgrastim
Treatment Location:Only at MDACC
Estimated Length of Stay in Houston:Participants will be in the hospital for approximately 7 days each course for 2
courses of high dose IL-2 given at 3 to 4 week intervals.
Supported By:N/A
Return Visit:Participants must return every 3 - 4 weeks for the first 2 months after
treatment. Then, every 1-3 months for the next 10 months.
Home Care:None


Hide details for Study Contact InformationStudy Contact Information

Physician Name:Patrick Hwu
Dept:Melanoma Medical Oncology
For Clinical Trial Enrollment:713-792-2921
For General Questions about Clinical Trials:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)


Show details for Study Objectives / OutcomesStudy Objectives / Outcomes
Show details for Study Status InformationStudy Status Information
Show details for Enrollment EligibilityEnrollment Eligibility
Show details for Resources and LinksResources and Links
Show details for ResultsResults