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Home > "V" Clinical Trials Conditions > Vaccination Against Melanoma and Other Cancers  Vaccination Against Melanoma and Other Cancers
Vaccination Against Melanoma and Other Cancers
For Condition: Colorectal Cancer,Breast Cancer,Non Small Cell Lung Carcinoma,Melanoma,Sarcoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will test the safety and effectiveness of an experimental anti-cancer vaccine in shrinking certain tumors. The vaccine is intended to stimulate white blood cells called lymphocytes-important cells of the immune system-to attack tumors containing MAGE-12, a protein fraction (peptide) produced by certain kinds of cancers, including melanoma, colorectal cancer, non-small cell lung cancer, breast cancer and sarcoma. The vaccine contains the MAGE-12 peptide and an oil-based liquid called Montanide ISA-51, another experimental substance that is intended to boost the immune reaction to MAGE-12. Patients 16 years of age and older with advanced cancer whose tumors produce MAGE-12 and for whom standard treatments no longer work may be eligible for this study. Candidates will be screened with a physical examination, blood and urine tests, chest X-ray, electrocardiogram, tumor biopsy to identify MAGE-12, X-ray and nuclear medicine imaging scans to evaluate the size and extent of tumor, and possibly a cardiac stress test and lung function test. In addition, a biopsy (removal of a small piece of tumor tissue) will be taken to determine HLA tissue type; patients must be type HLA-CW*0702, the type on which this vaccine is based. Participants will be randomly assigned to one of two treatment cycles: one group will receive the vaccine 4 times a week every week; the other group will receive it every 4 times a week every 3 weeks. The vaccine is given as an injection (shot) in the thigh. Physical examinations and blood tests will be done frequently to assess side effects. Patients will undergo leukapheresis before starting treatment and again after the fourth vaccine in patients receiving weekly injections, and after the second and fourth vaccine in those receiving injections every 3 weeks. This procedure is done to evaluate how the vaccine affects the action of lymphocytes. In this procedure, whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The lymphocytes are then removed, and the rest of the blood-red cells, platelets and plasma-is returned to the body through a second needle in the other arm. Patients receiving weekly injections return for follow-up examination in the clinic about 3 weeks after the fourth shot. Those receiving the vaccine every 3 weeks return for follow-up after the second and fourth shots. Patients whose tumors shrink in response to the peptide vaccine therapy may continue for up to 24 cycles. Those whose tumors do not shrink with the vaccine alone may also receive a drug called interleukin-2 (IL-2), which may boost the immune reaction to the vaccine. IL-2 is infused through a vein over 15 minutes, and is given every 8 hours for 4 days, after each vaccine injection.
Details: Patients with metastatic cancer who are HLA-Cw*0702 and whose tumors have demonstrable MAGE-12 expression will be immunized with a peptide from the MAGE-12 molecule that has been recently identified in the Surgery Branch as an epitope recognized by tumor infiltrating lymphocytes. This peptide will be administered either every week for 4 cycles or every three weeks for 4 cycles. Patients will be evaluated for toxicity, immunologic response and clinical response to peptide immunization.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Any patient age greater than or equal to 16 with measurable or evaluable metastatic cancer who is Cw*0702+, has failed standard treatment and has an expected survival of greater than three months will be considered. Histologic types included are cutaneous melanoma, ocular melanoma, colo-rectal carcinoma, non-small cell lung carcinoma, breast carcinoma, and sarcoma. Serum creatinine of 2.0 mg/dl or less. Total bilirubin 1.6 mg/dl or less. WBC 3000/mm(3) or greater. Platelet count 90,000 mm(3) or greater. Serum AST/ALT less than three times normal. ECOG performance status of 0 or 1 or 2. Patients of both genders must be willing to practice effective birth control during this trial. Demonstration of MAGE-12 expression by analysis of RT-PCR amplified tissue. Patients must be willing to undergo a biopsy. EXCLUSION CRITERIA: Patients will be excluded: Who are undergoing or have undergone in the past 3 weeks any other form of therapy except surgery for their cancer. Have active systemic infections, autoimmune disease or any known immunodeficiency disease. Who require steroid therapy. Who are pregnant. Who are known to be positive for hepatitis BsAG or HIV antibody. Who have any form of active primary or secondary immunodeficiency and must have recovered immune competence after chemotherapy or radiation therapy. IL-2 Criteria: To be eligible to receive IL-2, patients may not have active major medical illnesses such as cardiac ischemia, myocardial infarction, cardiac arrhythmias, obstructive or restrictive pulmonary disease. To be eligible to receive IL-2, patients must be willing to sign a durable power of attorney (DPA).
Total Enrollment: 112
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 000182; 00-C-0182
Study Start Date: July 24, 2000
Record last reviewed: October 22, 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006074
Other Non Small Cell Lung Carcinoma Studies:
1. A Study of ABT-751 in Patients With Colorectal Cancer
2. LMB-9 Immunotoxin in Treating Patients With Advanced Pancreatic, Esophageal, Stomach, Colon, or Rectal Cancer
3. Vaccination Against Melanoma and Other Cancers
4. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Gastrointestinal Cancer
5. Oxaliplatin Plus Irinotecan in Treating Patients With Metastatic Gastrointestinal Cancer
Related Studies:
Other Non Small Cell Lung Carcinoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Vaccination Against Melanoma and Other Cancers
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