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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 Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on 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 conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 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 Clinical research trials and 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 healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including 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. 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 Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a 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 clinical trial. Test subjects oftentimes recieve the best healthcare possible for their 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 condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > 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  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
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
For Condition: Breast Cancer,Colonic Neoplasm,Female Genital Neoplasm,Lung Cancer,Pancreatic Cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: Patients are treated in 2 different regimens. First, there is a total of 5 patients which are treated with antigen-presenting cells prepared by incubating peripheral blood mononuclear cells with either tumor-specific p53 peptide or ras peptide, and granulocyte-macrophage colony-stimulating factor (GM-CSF). Three weeks after all 5 patients are enrolled, the next patient with that particular peptide is recruited to the second regimen. The next regimen (Regimen B) starts by recruiting 28 patient, 14 with each peptide. If any immunologic of tumor response is seen in either p53 peptide or ras peptide patients, then further patients are recruited accordingly. Patients are treated on the same schedule with antigen-presenting cells (prepared as above), interleukin-2, and peptide-activated lymphocytes (prepared by incubating peripheral blood mononuclear cells with tumor-specific p53 or ras peptide and interleukin-2). Peptide-activated lymphocytes are intravenously infused 2 weeks after the antigen-presenting cells and followed 4 hours later by subcutaneous administration of interleukin-2.
Details: Human cancers have been found to be associated with mutations in dominant and recessive oncogenes. These genes produce mutated proteins that are unique to cancer cells. The p53 tumor suppressor gene and the ras oncogene are two of the most frequently mutated genes in human cancers. With a single amino acid mutation, the ras or the p53 proteins can potentiate transforming capabilities both in mouse and human cells. Such point mutations have been found in a broad spectrum of human carcinomas. These proteins get degraded in the cells and fragments are presented as small peptides bound to the major histocompatibility complex (MHC) molecules on the surface of the cells. The mutated peptides are potentially immunogenic for T lymphocytes. Animal data have shown that cytotoxic T lymphocytes (CTL) derived by vaccination with mutant p53 peptide pulsed peripheral blood mononuclear cells (PBMC) of mice can kill tumor cell targets which endogenously synthesize the corresponding mutant p53. These immune responses are specific for tumor cells expressing the mutant sequence corresponding to the vaccinating peptide and not for tumors expressing other mutant p53 proteins. We have found that the efficacy of peptide-pulsed cells as immunogenes for CTL induction can be enhanced by pulsing with peptide in the presence of GM-CSF. We propose to test whether vaccination with peptide pulsed PBMC in the presence GM-CSF can induce or enhance CTL response to the corresponding mutant p53 or ras. Also, since specific cytotoxic T cells can be generated in vitro by stimulating the vaccinated mice's primed T cells with the specific mutated peptide, and since in vitro expanded T cells [lymphocyte activated killer cells (LAK) and tumor infiltrating lymphocyte (TIL)] have been used along with IL-2 with some success in treating patients with specific cancers. We also propose to test whether the peptide-specific T cells can be used in adoptive immunotherapy in cancer patients by re-infusion of specific autologous primed T cells from vaccinated patients which have been stimulated and expanded in vitro with the appropriate peptide.
Eligibility:
Study Type: Interventional, Treatment, Safety
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Histologic diagnosis of tumor expressing mutant p53 or ras e.g. Lung, Colon, Breast, Pancreatic, Cervical, and Ovarian. The patient should have advanced disease that can not be cured by standard therapeutic intervention. Tumor tissue availability for determination of p53 or ras mutation (paraffin block, or fresh tissue). p53 or ras mutation should be either a point mutation, an insertion, or a deletion in the protein coding sequence. 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 biopsy procedure if his/her medical status allows the procedure to be performed with minimal risk. 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. The patient should have recovered from all acute toxicities of previous treatment. Patient should be more than 18 years old. EGOC performance status of 0 or 1. Ability to give informed consent. While measurable disease is preferable, it is not a necessity. All patients must have a signed consent, registered through Orkand before entering on the study. EXCLUSION CRITERIA: Any condition that does not fit in the 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 2000/mm(3); Lymphocytes less than 800/mm(3); Platelets less than 100K/mm(3); Creatinine greater than 2.0 mg/dl; Serum bilirubin greater than 2.0 mg/dl, SGPT greater than 4 times normal. Active second malignancy other than carcinoma in-situ or cervix or basal cell carcinoma of the skin. History of CNS metastases. Active ischemic heart disease (i.e. Class III or VI cardiac disease-New York Heart Association), or a recent history of myocardial infarction (within the last 6 months). Unresponsiveness to skin test antigens. Autoimmune disease e.g., SLE, MS, ankylosing spondylitis, etc. Active infections requiring antibiotics. Weight loss of greater than 20% in the last 6 months. 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: 70
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 950105; 95-C-0105
Study Start Date: April 7, 1995
Record last reviewed: February 28, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001434
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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
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