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Home > "P" Clinical Trials Conditions > p53 Peptide Vaccination to Treat Lung Cancer  p53 Peptide Vaccination to Treat Lung Cancer
p53 Peptide Vaccination to Treat Lung Cancer
For Condition: Non-Small-Cell Lung Carcinoma
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will evaluate the effect of a specially tailored vaccine to treat patients with non-small cell lung cancer. About 50 to 60 percent of patients with this type of cancer have a defective gene called p53, which produces a protein that protects their tumor from attack by the immune system. The vaccine is designed to stimulate the immune system to recognize the tumor cells and kill them. The faulty p53 gene can cause various types of abnormalities that result in runaway growth of cancer cells. Each patient's vaccine will be custom matched to their specific p53 abnormality. After completing standard treatment--which may include chemotherapy, radiation and surgery--patients will be infused with the vaccine once a week for five weeks. Patients whose tumors respond to the treatment may receive additional vaccinations at two-month intervals for as long as they continue to benefit. In a previous small study, five out of five patients showed an immune response to p53 peptide vaccination. Candidates for the study will be screened with a medical history, blood and urine tests and imaging studies (X rays and CT scans). A tumor sample will also be taken to see if it has a p53 abnormality suitable for this study. Study patients will undergo apheresis-a procedure to collect white blood cells needed to make their vaccine. In apheresis, blood is drawn through a needle in one arm, similar to donating blood. The blood goes through a machine that separates out some of the white cells, and the rest of the blood is returned, usually through a needle in the other arm. Patients will also have additional physical exams, blood tests, and imaging studies during the course of the study to evaluate the effects of treatment.
Details: Common human cancers, including lung cancer, have been found to be associated with mutations in dominant and recessive oncogenes, including the p53 gene. These cancers frequently produce mutant oncogenic proteins that are uniquely present and over-expressed in the patient's cancer cells, but not in their normal cells. Numerous somatic genetic abnormalities have been documented in cancer patients. The most extensively studied of these mutations is that of p53 which is present in approximately 50% of all cancers and in roughly 60% of non-small cell lung cancers. Mechanisms such as deletions, frameshifts, and point mutations are responsible for the development of a mutant product unique to the patient's tumor cells which allows for unregulated cell growth. This tumor specific mutant oncoprotein could form the basis for specific tumor targeted immunotherapy. Non-small cell lung cancer (NSCLC) is the leading cause of cancer death among men and women in the United States, with roughly 180,000 new cases per year. Approximately one-third of NSCLC patients present with locally advanced disease (stage IIIA and IIIB). Despite the best conventional therapy, over 80% of these patients will die from their disease. In this protocol, we propose to evaluate the adjuvant treatment of stage III NSCLC patients after standard therapy with mutant p53 peptides custom synthesized to correspond to the mutation present in each patient's tumor. In our previous study, we have been able to demonstrate specific cytokine responses to mutant p53 peptides administered in the adjuvant setting in five out of five patients. We, therefore, believe that the adjuvant treatment of patients with lung cancer at very high risk of rapid relapse represents the optimal group in which to study the clinical response to vaccination. To accomplish this, tumor samples will be analyzed for the presence of mutations in the p53 oncogene and a custom mutant peptide will be synthesized. It will then be used to immunize those patients after recovery from standard therapy in an attempt to induce cytotoxic T cells that specifically recognize and kill tumor cells expressing this mutant protein. The patients will be vaccinated with autologous dendritic cells produced in vitro and pulsed with custom-made synthetic mutant p53 peptide. These peptide pulsed dendritic cells will be administered weekly for five weeks via intravenous infusion in an effort to generate a host mediated immune response targeted exclusively against the tumor cells. We will then analyze both the patient's immune response to these peptides and their survival as endpoints of our study.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: NOTE: all of these criteria must be confirmed within 4 weeks of initial vaccination and be confirmed prior to genetic screening for p53 mutations INCLUSION CRITERIA: Histologic diagnosis of non-small cell lung cancer. AJCC stage IIIA or IIIB NSCLC except for patients with pleural effusions. Patients with significant pleural effusions are excluded from this study. Patients must have completed or plan to undergo a form of curative-intent therapy for their lung cancer. Curative intent therapy is defined as at least two cycles of preoperative chemotherapy for resectable patients with known N2 or N3 disease or at least 55 Gy radiation with concomitant or sequential chemotherapy for patients judged to be unresectable. For patients found to have incidental N2 or N3 disease at time of surgery (disease not detected with staging evaluation prior to definitive surgery) adjuvant chemotherapy and radiation therapy are optional. Eastern Cooperative Oncology Group PS 0-1. Ability to give informed consent. Adequate organ function including: Renal: serum creatinine less than 2.5 mg/dl; Marrow: total lymphocyte count greater than 475/mm(3), total granulocytes greater than 1000/mm(3), and platelets greater than 100,000/mm(3); Hepatic: Serum total bilirubin less than 2.0 mg/dl, SGOT less than 3.0 x normal. Submission of pathology specimen(s) for screening for one of the following types of p53 mutations: point mutation altering the protein sequence or a frame shift mutation with the generation of a novel sequence. EXCLUSION CRITERIA: HIV positivity, or history of Hepatitis C virus infection or active Hepatitis B virus infection due to their known effects on the immune response. Significant pleural effusion defined as a pleural effusion visible on plain chest radiograph (whether or not cytology is positive for malignancy). Pregnancy or breast feeding. Other malignancies within five years, unless the probability of recurrence from prior malignancy is less than 5%. Patients who have had a malignant tumor in the past and have been disease free for at least five years are also eligible for this study. A condition, psychiatric or otherwise, that would preclude consistent follow-up or compliance with any component of the study. Myocardial infarction or significant ventricular arrhythmias within the last six months. Any other serious medical condition that limits life expectancy to less than 2 years. Hypercalcemia (serum calcium greater than or equal to 11.0 mg/dl (2.75 mmol) corrected for serum albumin). Serum albumin less than 3.0 gm/dL. Any serious ongoing infection. An allergy to eggs will not exclude a patient from this study. However, patients with egg allergies will not undergo influenza vaccination.
Total Enrollment: 120
Location and Contact Information:
National Cancer Institute (NCI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Wendy Gao 3014021898
Additional Information:
Study ID Numbers: 990142; 99-C-0142
Study Start Date: July 16, 1999
Record last reviewed: July 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001829
Other Non-Small-Cell Lung Carcinoma Studies:
1. p53 Peptide Vaccination to Treat Lung Cancer
2. Study of EKB-569 in Subjects with Advanced Non-Small Cell Lung Cancer
3. Study of Gene Induction Mediated by Sequential Decitabine/Depsipeptide Infusion in Patients with Pulmonary and Pleural Malignancies
4. Study of ILX651 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Carcinoma
5. Oral ZD1839 (IRESSA®) Versus Intravenous Docetaxel (TAXOTERE®) in Patients With Non-Small Cell Lung Cancer
Related Studies:
Other Non-Small-Cell Lung Carcinoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
p53 Peptide Vaccination to Treat Lung Cancer
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