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Telomerase Vaccination for Metastatic Cancer Clinical Trials Information presented on Clinical Trials Search isn't designed to be a substitute for certified healthcare advice, travels to or professional assistance using a genuine medical doctor. We are not physicians. Always confer with your dr. about Telomerase Vaccination for Metastatic Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Telomerase Vaccination for Metastatic Cancer Clinical research trials and Telomerase Vaccination for Metastatic Cancer medical trials happen in hundreds of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectualness of new drugs. The intention of the studies / undertakings is to solve certain human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all forms of circumstances, such as Telomerase Vaccination for Metastatic Cancer. Telomerase Vaccination for Metastatic Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment choices before they are available to the general public. Some times the human subjects get treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Telomerase Vaccination for Metastatic Cancer clinical trial. Participants frequently get the best healthcare available for their Telomerase Vaccination for Metastatic Cancer condition. Risks are a reality, nonetheless, and can include extra or frequent physician trips, medical risks (possibly life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Telomerase Vaccination for Metastatic Cancer  Telomerase Vaccination for Metastatic Cancer
Telomerase Vaccination for Metastatic Cancer
For Condition: Cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will test the safety and effectiveness of an experimental vaccine for fighting metastatic cancer-that is, disease that has spread from the primary site. The vaccine contains a peptide (piece of a protein) called telomerase, which is made by several different kinds of cancers. It also contains an oil-based liquid called Montanide ISA-51, another experimental substance that is intended to boost the immune reaction to the peptide. Patients 16 years of age and older who have metastatic cancer that does not respond to standard treatment or who have been treated with radiation for malignant glioma (brain tumor) may be eligible for this study. Candidates will be screened with a medical history and physical examination, chest X-ray, electrocardiogram, blood and urine tests, and X-rays and scans to evaluate the extent and size of the tumor. Because the vaccine formulation is based on tissue type, participants will have a blood test to determine that tissue type is HLA-A0201. Depending on the type and location of their tumor, a biopsy may be done with a needle (needle biopsy), with a small sharp cookie-cutter instrument (punch biopsy), or with a small knife (excisional biopsy). Participants will be randomly assigned to receive vaccine either once a week for 10 weeks, followed by a 3-week break; once every 3 weeks for four times; or four times a week every 3 weeks for four times. The vaccine is given as an injection (shot) in the thigh. A physical examination and blood tests will be done at each treatment visit to monitor side effects. About 40 cc (8 teaspoons) of blood will be drawn every 3 weeks to monitor body functions. Patients will undergo leukapheresis to evaluate how the vaccine affects the action of lymphocytes-white blood cells of the immune system. 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. All patients will undergo leukapheresis just before beginning treatment. The procedure may be repeated after the fourth vaccine in patients receiving weekly injections, and after the second and fourth vaccine cycles in patients receiving injections every 3 weeks. Patients will return for follow-up studies after the fourth weekly injection, or after the second and fourth injections for those on the every-3-weeks injection schedule. If the tumor has responded to the vaccine, the treatment may be repeated on the same schedule for up to 12 months, with continuing follow-up visits. Some patients may have a needle biopsy of normal skin and tumor or lymph node to examine the effects of the vaccine on the immune cells in the tumor. Patients with metastatic melanoma whose cancer progresses during peptide treatment may be given a drug called interleukin-2 (IL-2), to boost the immune reaction to the tumor. 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-A*0201 will be immunized with an immunogenic peptide from the telomerase protein. This peptide will be administered either every week for four cycles followed by a three week break and then repeat peptide every week for four cycles, every three weeks for four cycles, or four times a week every three weeks for four cycles. Patients will be evaluated for toxicity, immunological 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 years with evaluable metastatic cancer who is HLA-A0201, has disease refractory to standard treatment or who is post radiation for a malignant glioma, and has an expected survival of greater than three months will be considered. 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. Must be willing to undergo leukapheresis. EXCLUSION CRITERIA: Patients will be excluded: Who are undergoing or have undergone in the past 3 weeks any systemic therapy for their cancer. Have active systemic infections, autoimmune disease or any known immunodeficiency disease. Who require systemic steroid therapy. Who are pregnant. Who are known to be positive for hepatitis B(s)AG or HIV antibody. Who have any form of active primary or secondary immunodeficiency or who have not recovered immune competence after chemotherapy or radiation therapy as evidence by abnormal lymphocyte counts, abnormal WBC or presence of opportunistic infections. Who have previously been immunized to telomerase. IL-2 CRITERIA: To be eligible to receive IL-2, patients may not have active major medical illnesses such as cardiac ischemia as evidence by a stress thallium or comparable test, 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: 162
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 010176; 01-C-0176
Study Start Date: May 16, 2001
Record last reviewed: May 3, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016640
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3. Biomarkers of Benzene Exposure in Inner City Residents
4. High-Dose Chemotherapy, Total-Body Irradiation, and Autologous Stem Cell Transplantation or Bone Marrow Transplantation in Treating Patients With Hematologic Cancer or Solid Tumors
5. Vaccination with tetanus and KLH to assess immune responses.
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Telomerase Vaccination for Metastatic Cancer
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