Melanoma (Skin) Clinical Trial
Official title:
Phase I Study of In Vivo Expansion of Melan-A/MART-1 Antigen-Specific CD8 T Lymphocytes Following Transient Immunosuppression in Patients With Advanced Melanoma
Verified date | November 2012 |
Source | Centre Hospitalier Universitaire Vaudois |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and fludarabine, may be used
to prepare the body for other treatments, such as cellular adoptive immunotherapy.
Biological therapies, such as cellular adoptive immunotherapy, may stimulate the immune
system in different ways and stop tumor cells from growing. Vaccines may help the body build
an effective immune response to kill tumor cells. Giving cyclophosphamide together with
fludarabine followed by biological therapy may be an effective treatment for metastatic
melanoma.
PURPOSE: This phase I trial is studying the side effects of giving cyclophosphamide together
with fludarabine followed by cellular adoptive immunotherapy, and vaccine therapy in
treating patients with metastatic melanoma.
Status | Completed |
Enrollment | 8 |
Est. completion date | |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Diagnosis of metastatic melanoma - Progressive disease after receiving prior Melan-A peptide vaccine on an immunotherapy protocol of the Ludwig Institute AND achieved a detectable immune response (increase of specific CD8^+ TET^+ Melan-A) - Tumor must express MART-1/Melan-A antigen - HLA-A2 positive - Not eligible for other protocols due to progressive disease OR maximum number of vaccine injections with stable disease has been attained PATIENT CHARACTERISTICS: - Performance status 0-2 - Whole blood counts normal - Pulmonary status normal - Transaminases < 1.5 times upper limit of normal (ULN) - Gamma-glutamyl-transferase < 1.5 times ULN - Bilirubin normal - Creatinine clearance > 70 mL/min - No major uncontrolled heart disease - No arterial hypertension PRIOR CONCURRENT THERAPY: - See Disease Characteristics - Prior chemotherapy, biologic therapy, radiotherapy, and/or surgery allowed |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne |
Lead Sponsor | Collaborator |
---|---|
Prof. Serge Leyvraz |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phenotype, function, and T-cell receptor repertoire | Anti-tumor immune response evaluated at each vaccine and until the last administered vaccine | No | |
Primary | Tumor response | Tumor response evaluated 4 weeks after last vaccine | No | |
Primary | Toxicity | Within 30 days after completion of the last vaccine | Yes |
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