|
Vaccine Therapy with Tumor Specific Mutated RAS Peptides and IL-2 or GM-CSF for Adult Patients with Solid Tumors Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Vaccine Therapy with Tumor Specific Mutated RAS Peptides and IL-2 or GM-CSF for Adult Patients with Solid Tumors conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Vaccine Therapy with Tumor Specific Mutated RAS Peptides and IL-2 or GM-CSF for Adult Patients with Solid Tumors Clinical research trials and Vaccine Therapy with Tumor Specific Mutated RAS Peptides and IL-2 or GM-CSF for Adult Patients with Solid Tumors medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Vaccine Therapy with Tumor Specific Mutated RAS Peptides and IL-2 or GM-CSF for Adult Patients with Solid Tumors. Vaccine Therapy with Tumor Specific Mutated RAS Peptides and IL-2 or GM-CSF for Adult Patients with Solid Tumors Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Vaccine Therapy with Tumor Specific Mutated RAS Peptides and IL-2 or GM-CSF for Adult Patients with Solid Tumors clinical trial. Participants oftentimes recieve the finest healthcare available for their Vaccine Therapy with Tumor Specific Mutated RAS Peptides and IL-2 or GM-CSF for Adult Patients with Solid Tumors condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "V" Clinical Trials Conditions > Vaccine Therapy with Tumor Specific Mutated RAS Peptides and IL-2 or GM-CSF for Adult Patients with Solid Tumors  Vaccine Therapy with Tumor Specific Mutated RAS Peptides and IL-2 or GM-CSF for Adult Patients with Solid Tumors
Vaccine Therapy with Tumor Specific Mutated RAS Peptides and IL-2 or GM-CSF for Adult Patients with Solid Tumors
For Condition: Colonic Neoplasm,Lung Neoplasm,Neoplasm,Pancreatic Neoplasm,Thyroid Neoplasm
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Vaccination is administered to 2 separate groups of 14-30 patients each. Patients in group A are given the vaccination in combination with interleukin-2 (IL-2), and patients in group B are given the vaccination in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF). The ras peptide and Detox PC mixture is administered subcutaneously every 5 weeks on the IL-2 arm (group A) and every 4 weeks on the GM-CSF arm (group B) for a total of 3 vaccinations. IL-2 is administered subcutaneously for 5 days a week for 2 weeks starting 4 days after vaccination. GM-CSF is administered subcutaneously for 4 days starting 1 day prior to the vaccination. On day 2, GM-CSF is administered directly after the vaccination. If patients show evidence of disease response or stable disease, 3 additional vaccinations will be given.
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 extensively 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 Ras 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 are currently conducting a phase I clinical trial in which we are vaccinating patients with point mutated Ras peptides that correspond to the mutation they harbor in their tumor. We have seen no serious side effects, and a few patients have generated specific immune response to the mutated peptide. Here we propose to take this trial further by using the highest tolerable dose of the Ras peptide with the adjuvant along with cytokines that could enhance the body's immunological response. Therefore, we propose to treat three groups of patients; on one group we will use IL-2 and on the second group GM-CSF will be given along with the Ras peptide-adjuvant mixture and on the third group a combination of both GM-CSF and IL-2 will be administered with the peptide vaccination.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients must be 18 years of age of older. Histologic diagnosis of solid tumors potentially expressing mutant ras, including colon, lung, pancreas, thyroid, endometrial, head and neck, testicular, hepatocellular, and melanoma. Tumor tissue availability for determination of ras mutation (paraffin block, or fresh tissue). Ras mutation must be one of the following point mutations at codon 12: Gly to Cys, Gly to Asp, or Gly to Val. Patients should have metastatic disease for which no further chemotherapy or radiation options which are known to increase survival are available. ECOG performance status of 1 or 0. Expected survival more than 3 months. While measurable disease is preferable, it is not a necessity. The patient should not have received chemotherapy, radiation therapy, immunotherapy or steroids for at least 4 weeks prior to starting vaccination. Patients should have recovered from all acute toxicities of previous treatment. Patients must understand and sign an informed consent document that explains the neoplastic nature of his/her disease, the procedures to be followed, the experimental nature of the treatment, alternative treatments, and potential risks and toxicities. EXCLUSION CRITERIA: Any of the following: WBC less than 2000/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 4 times normal. HIV or Hepatitis B or C infection (i.e. detectable HBS Antigen or HC antibodies). Pregnant women or nursing mothers are ineligible. Women with reproductive potential must have negative pregnancy test. Men and women of reproductive potential must use adequate contraception. Patients with active ischemic heart disease, a recent history of myocardial infarction (within the last 6 months), History of congestive heart failure, ventricular arrythmias or other arrythmias requiring therapy, or any other medical conditions that the principal investigator sees to be unfit for such therapy. Active second malignancy other than curatively treated carcinoma in-situ of cervix or basal cell carcinoma of the skin. History of CNS metastases. Patients with History of autoimmune disease e.g. (autoimmune neutropenia, thrombocytopenia, or hemolytic anemia; systemic lupus erythematosus, Sjogren syndrome, or scleroderma; myasthenia gravis; Goodpasture syndrome; Addison's disease, Hashimoto's thyroiditis, or aactive Graves disease). Patients with active infections requiring antibiotic. History of allergy to eggs are not eligible. If, in the opinion of the principal or associate investigators, it is not in the best medical interest of the patient to enter this study, the patient will be ineligible.
Total Enrollment: 60
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 970141; 97-C-0141
Study Start Date: July 3, 1997
Record last reviewed: May 5, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001581
Other Colonic Neoplasm Studies:
1. Treatment of Peritoneal Cancer with Surgery, Perfused Heated Cisplatin, and Chemotherapy
2. Outcomes in Education and Counseling for HNPCC Testing
3. Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas that Express Lewis Y Antigen
4. Vaccine Therapy with Tumor Specific Mutated P53 or Ras Peptides Alone or in Combination with Cellular Immunotherapy with Peptide Activated Lymphocytes (PAL Cells) Along with Subcutaneous IL-2
5. Vaccine Therapy with Tumor Specific Mutated RAS Peptides and IL-2 or GM-CSF for Adult Patients with Solid Tumors
Related Studies:
Other Colonic Neoplasm Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Vaccine Therapy with Tumor Specific Mutated RAS Peptides and IL-2 or GM-CSF for Adult Patients with Solid Tumors
|
|
|
|
|
|
|
|
