Status:
COMPLETED
Combined Modality Treatment for Patients With Stage IV Melanoma
Lead Sponsor:
Baylor Research Institute
Conditions:
Malignant Melanoma Stage IV
Eligibility:
All Genders
21-75 years
Phase:
PHASE1
PHASE2
Brief Summary
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.
Detailed Description
A novel dendritic cell vaccine is being developed at the Baylor Institute for Immunology Research. Pre-clinical studies have found that this dendritic cell vaccine is more efficient in inducing a tumo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00313235
Start Date
March 1 2006
End Date
June 1 2012
Last Update
June 13 2013
Active Locations (1)
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1
Baylor University Medical Center
Dallas, Texas, United States, 75246