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Vaccine Therapy and Detection of Immunologic Responses with Tumor Specific Mutated RAS Peptides in Adult Cancer Patients with Solid Tumors Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Vaccine Therapy and Detection of Immunologic Responses with Tumor Specific Mutated RAS Peptides in Adult Cancer Patients with Solid Tumors conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Vaccine Therapy and Detection of Immunologic Responses with Tumor Specific Mutated RAS Peptides in Adult Cancer Patients with Solid Tumors Clinical research trials and Vaccine Therapy and Detection of Immunologic Responses with Tumor Specific Mutated RAS Peptides in Adult Cancer Patients with Solid Tumors medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Vaccine Therapy and Detection of Immunologic Responses with Tumor Specific Mutated RAS Peptides in Adult Cancer Patients with Solid Tumors. Vaccine Therapy and Detection of Immunologic Responses with Tumor Specific Mutated RAS Peptides in Adult Cancer Patients with Solid Tumors Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Vaccine Therapy and Detection of Immunologic Responses with Tumor Specific Mutated RAS Peptides in Adult Cancer Patients with Solid Tumors clinical trial. Subjects often receive the most expert healthcare possible for their Vaccine Therapy and Detection of Immunologic Responses with Tumor Specific Mutated RAS Peptides in Adult Cancer Patients with Solid Tumors condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy and Detection of Immunologic Responses with Tumor Specific Mutated RAS Peptides in Adult Cancer Patients with Solid Tumors  Vaccine Therapy and Detection of Immunologic Responses with Tumor Specific Mutated RAS Peptides in Adult Cancer Patients with Solid Tumors
Vaccine Therapy and Detection of Immunologic Responses with Tumor Specific Mutated RAS Peptides in Adult Cancer Patients with Solid Tumors
For Condition: Neoplasm
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This is a dosage escalation study to estimate the optimum immunization dose of ras peptide mixed with the immunologic adjuvant Detox. Groups of 3 to 6 patients receive the ras peptide/Detox vaccine monthly for 3 months. Patients with stable or responding disease or with a specific immunologic response may receive 3 additional monthly vaccinations.
Details: Cancers in humans are commonly associated with mutations in dominant and recessive oncogenes. These genes produce mutated proteins that are unique to cancer cells. Ras proto-oncogenes are the best characterized mutated genes in human cancers. They encode a highly conserved family of 21 Kd proteins. With a single amino acid mutation, the ras protein can potentiate transforming capabilities both in mouse and human cells. Such point mutated ras have been found in a broad spectrum of human carcinomas notably at codons 12, 13, and 61. Codon 12 mutations form more than 90% of all ras mutations in human cancers. These proteins get degraded in the cells and present themselves as small peptides through the major histocompatibility complex (MHC) molecules on the surface of the cells, this would render these peptides potentially immunogenic through exposure to T lymphocytes. Animal data have shown that subcutaneous immunization of mice with short synthetic peptides (Ras 5-17) corresponding to different mutations at codon 12 induces specific immune response for some of these mutations. We propose to test whether point mutated ras peptide can be targeted via vaccination of cancer patients with peptides reflecting those mutants. Patients with cancers that potentially express mutated ras, e.g. colon, pancreas, lung, breast will be screened for the mutated ras gene. Those that have any of 3 specific mutations on codon 12 (Gly to Cys, Gly to Asp, or Gly to Val) will be vaccinated.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Histologic diagnosis of solid tumors potentially expressing mutant ras, including colon, lung, pancreas, breast and prostate. Tumor tissue availability for determination of ras mutation (paraffin block, or fresh tissue). ras mutation should be a specific point mutation in codons 12 which include: Gly to Cys, Gly to Asp, or Gly to Val. It is preferable to have tumor tissue available for preparation of a tumor cell line, and tumor or lymph node tissue for expansion of tumor infiltrating lymphocytes (TIL) for in-vitro laboratory studies. If fresh tissue is not available, the patient may be requested to undergo a surgical biopsy procedure if the medical status of the patient permits the procedure and minimal patient risk is undertaken. Surgical procedures to be performed are those that can be done under local anesthesia or are otherwise indicated for the standard care of the patient. Patient's consent to such a procedure is not a requirement for protocol entry. The patient should not have received chemotherapy, radiation therapy, immunotherapy or steroids for at least 4 weeks prior to starting vaccination. And the patient should have recovered from all acute toxicities of previous treatment. The patient should have metastatic disease for which no further chemotherapy or radiation options which are known to increase survival are available. On the highest tolerable dose level additional patients will be entered if they have: Adenocarcinoma of the lung stage II or III after surgery or radiation therapy; SCLC, limited or extensive disease in CR; Colorectal Ca Duke C who received appropriate adjuvant chemotherapy; Fully resected pancreatic or fully resected recurrent colorectal carcinoma. Patients should be 18 years of age or older. ECOG performance status of 1 or 0. Ability to give informed consent. While measurable disease is preferable, it is not a necessity. Expected survival more than 3 months. EXCLUSION CRITERIA: Any condition that does not fit with Inclusion Criteria. HIV or Hepatitis B or C infection. Pregnant women or nursing mothers are ineligible. Women with reproductive potential must have negative pregnancy test. Men and women of reproductive age should use adequate contraception. Any of the following: WBC less than 3000/mm (3), Lymphocytes less than 600/mm (3), Platelets less than 100K/mm(3); Creatinine greater than 2.0 mg/dl; Serum Bilirubin greater than 2.0 mg/dl, SGOT, or SGPT greater than 4X normal. History of second malignancy other than curatively treated carcinoma in-situ of cervix or basal cell carcinoma of the skin. History of CNS metastases. Patients with active ischemic heart disease (i.e. Class III or VI cardiac disease-New York Heart Association), a recent history of myocardial infarction (within the last 6 months), history of arrhythmia or other clinical symptoms suggesting cardiac or pulmonary insufficiency. Unresponsiveness to skin test antigens. Patients with autoimmune disease e.g. SLE, MS, ankylosing spondylitis, etc. Patient with active infections requiring antibiotics.
Total Enrollment: 33
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 940096; 94-C-0096
Study Start Date: March 1, 1994
Record last reviewed: March 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001380
Other Neoplasm Studies:
1. A Phase I Trial of Daily Bolus Flavopiridol in Patients with Refractory Neoplasms
2. Eligibility Screening for a NCI Pediatric Oncology Branch Research Study
3. Process and Outcomes of Pain Management
4. Defining the Genetic Basis for the Development of Primary Pigmented Nodular Adrenocortical Disease (PPNAD) and the Carney Complex
5. Cellular Immunotherapy with Autologous T Lymphocytes Stimulated with the Patient's Tumor-Specific Mutated Ras Peptides
Related Studies:
Other Neoplasm Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Vaccine Therapy and Detection of Immunologic Responses with Tumor Specific Mutated RAS Peptides in Adult Cancer Patients with Solid Tumors
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