Combined Modality Treatment for Patients With Stage IV Melanoma

Completed · Phase 1/Phase 2

Conditions studied: Malignant Melanoma Stage IV

In brief

The purpose of this study is to test a combined treatment using cyclophosphamide and a novel dendritic cell vaccine in patients with Stage IV melanoma.

Key facts

Study ID

NCT00313235

Run by

Baylor Research Institute

People needed

41

Starts

2006-03-01

Expected to finish

2012-06-01

Last updated by the study team

2013-06-13

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.
• Ages 21-75.
• Karnofsky performance status greater than/equal to 80%.
• Measurable metastatic lesions by physical exam or scans.
• Acceptable CBC and blood chemistry results.
• Adequate hepatic and renal function.
• No active CNS metastatic disease. If CNS history is present, lesions must have been resected by surgery and/or gamma knife irradiation at least 3 months prior to study entry. The total number of CNS lesions at diagnosis should not exceed 3.
• Written informed consent.

You may not qualify if…

• Patients that 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 IFN alpha-2b or 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 diagnosed with more than 3 CNS metastatic melanoma lesions.
• More than 5 hepatic lesions or any hepatic lesion larger than 5 cm.
• Baseline serum LDH greater than 1.1 times the upper limit of normal.
• Patients who are HIV positive.
• Patients who are pregnant.
• Patients who have receive corticosteroids or other agents less than 4 weeks before beginning the trial.
• Patients with asthma, angina pectoris or congestive heart failure.
• Patients with autoimmune disease 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

• Baylor University Medical Center — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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