Overview

Cyclophosphamide and Fludarabine Followed by Cellular Adoptive Immunotherapy and Vaccine Therapy in Patients With Metastatic Melanoma

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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, 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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Prof. Serge Leyvraz
Treatments:
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Vaccines
Criteria
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