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

NCT00324623 Phase 1 COMPLETED

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.

Details

Lead sponsor	Prof. Serge Leyvraz
Phase	Phase 1
Status	COMPLETED
Enrolment	8
Start date	2005-09

Conditions

• Melanoma (Skin)

Interventions

• Melan-A VLP vaccine, IMP321 adjuvant
• adoptive immunotherapy
• therapeutic autologous lymphocytes
• cyclophosphamide
• fludarabine phosphate

Primary outcomes

• Phenotype, function, and T-cell receptor repertoire — Anti-tumor immune response evaluated at each vaccine and until the last administered vaccine
• Tumor response — Tumor response evaluated 4 weeks after last vaccine
• Toxicity — Within 30 days after completion of the last vaccine

Countries

Switzerland