Chemotherapy Followed by ESO-1 Lymphocytes and Aldesleukin to Treat Metastatic Cancer

Study Summary

Background: -This study uses an experimental cancer treatment that uses the patient s own lymphocytes (type of white blood cell), which are specially selected and genetically modified to target and destroy their tumor. Objectives: -To test the safety of the treatment and determine if it can cause the patient s tumor to shrink. Eligibility: * Patients greater than 18 years and less than or equal to 66 years of age whose cancer has spread beyond the original site and does not respond to standard treatment. * Patients have tissue type human leukocyte antigen (HLA)-A\*0201. * Patients cancer cells have the ESO-1 gene. Design: * Workup: Patients have scans, x-rays, laboratory tests, and other tests as needed. * Patients have leukapheresis to collect cells for laboratory treatment and later reinfusion. For this procedure, whole blood is collected thorough a tube in a vein, the desired cells are extracted from the blood, and the rest of the blood is returned to the patient. * Chemotherapy: Patients have low-dose chemotherapy for 1 week to prepare the immune system to receive the treated lymphocytes. * Cell infusion and aldesleukin (IL-2) treatment: Patients receive the lymphocytes by a 30-minute infusion through a vein. Starting within 24 hours of the infusion, they receive high-dose aldesleukin infusions every 8 hours for up to 5 days (maximum15 doses). * Recovery: Patients rest for 1 to 2 weeks to recover from the effects of chemotherapy and aldesleukin. * Tumor biopsy: Patients may be asked to undergo a biopsy (surgical removal of a small piece of tumor) after treatment to look at the effects of treatment on the immune cells in the tumor. * Follow-up: After treatment is completed, patients return to the clinic once a month for several months for physical examinations, a review of side effects, laboratory tests and scans. They may undergo leukapheresis at some visits to look at the effect of treatment on the immune system and check the viability of the infused cel

Primary Outcome

Response was determined by the RECIST. Complete response (CR) is disappearance of all target lesions. Partial response (PR) is at least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive disease (PD) is at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable disease (SD) is neither sufficien

Interventions

• DRUG Cyclophosphamide
• DRUG aldesleukin
• DRUG fludarabine phosphate
• BIOLOGICAL Anti-NY ESO-1 T-cell receptor PBL
• BIOLOGICAL ALVAC NY ESO-1 vaccine