Status:
COMPLETED
Cyclophosphamide and Fludarabine Followed by Cellular Adoptive Immunotherapy and Vaccine Therapy in Patients With Metastatic Melanoma
Lead Sponsor:
Prof. Serge Leyvraz
Conditions:
Melanoma (Skin)
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
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, su...
Detailed Description
OBJECTIVES: * Determine the magnitude and duration of the expansion of antigen-specific T-cells present in post-vaccination peripheral blood mononuclear cells and reinfused after immunosuppression in...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00324623
Start Date
September 1 2005
Last Update
November 20 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011