Vaccination of Patients With Stage IV Melanoma With Dendritic Cells

Completed · Phase 1/Phase 2

Conditions studied: Melanoma, Neoplasm Metastasis

In brief

The purpose of this study is to test a novel dendritic cell (DC) vaccine in patients with Stage IV melanoma.

Key facts

Study ID

NCT00125749

Run by

Baylor Research Institute

People needed

30

Starts

2005-07-01

Expected to finish

2007-06-01

Last updated by the study team

2017-06-12

Who can join

Age: 21 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Stage M1a, M1b, M1c biopsy proven metastatic melanoma
• Failure of at least one prior chemotherapy regimen of DTIC and/or temozolomide with/without interleukin-2 (IL-2).
• Karnofsky performance status greater than/equal to 80%.
• Measurable metastatic lesions by physical exam or scans.
• Acceptable CBC and blood chemistry results
• Adequate renal function.
• Written informed consent.

You may not qualify if…

• Patients who have received more than 8 cycles of chemotherapy for metastatic melanoma.
• Patients who have received chemotherapy less than 4 weeks before beginning the trial.
• Patients who have received interferon (IFN) alpha-2b or granulocyte-monocyte colony-stimulating factor (GM-CSF) less than 4 weeks before beginning the trial.
• Patients who have received high-dose IL-2 less than 4 weeks before beginning the trial.
• Patients with a history of central nervous system (CNS) metastatic melanoma.
• More than 5 hepatic lesions or any hepatic lesion larger than 5 cm.
• Baseline serum LDH greater than 4 times the upper limit of normal.
• Patients who are HIV positive.
• Patients who are pregnant.
• Patients who have received corticosteroids or other agents less than 4 weeks before beginning the trial.
• Patients with asthma, angina pectoris or congestive heart failure.
• Patients with autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis.
• Patients with active infections including viral hepatitis.
• Patients with a history of any other neoplastic disease less than 5 years ago (carcinomas in situ of the cervix and basal/squamous cell carcinomas of the skin, however, can be admitted to the study).

Where it is running

• Mary Crowley Medical Research Center: Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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