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 this clinical research study is to learn if a vaccine prepared from
special blood cells (dendritic cells) will improve the function of fighting
immune cells (T cells) specific for melanoma. These special blood cells and
immune cells will be taken from patient's blood and tissue 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). Researchers will also
study if this combination will help to control the disease if there is a BRAF
mutation of the melanoma.

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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


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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.)


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