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Phase I Study of Vaccination With MUC-1 Antigen and Immunologic Adjuvant SB AS-2 in Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer 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 Phase I Study of Vaccination With MUC-1 Antigen and Immunologic Adjuvant SB AS-2 in Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase I Study of Vaccination With MUC-1 Antigen and Immunologic Adjuvant SB AS-2 in Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer Clinical research trials and Phase I Study of Vaccination With MUC-1 Antigen and Immunologic Adjuvant SB AS-2 in Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer 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 Phase I Study of Vaccination With MUC-1 Antigen and Immunologic Adjuvant SB AS-2 in Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer. Phase I Study of Vaccination With MUC-1 Antigen and Immunologic Adjuvant SB AS-2 in Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer 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 Phase I Study of Vaccination With MUC-1 Antigen and Immunologic Adjuvant SB AS-2 in Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Phase I Study of Vaccination With MUC-1 Antigen and Immunologic Adjuvant SB AS-2 in Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer 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 > "P" Clinical Trials Conditions > Phase I Study of Vaccination With MUC-1 Antigen and Immunologic Adjuvant SB AS-2 in Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer  Phase I Study of Vaccination With MUC-1 Antigen and Immunologic Adjuvant SB AS-2 in Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer
Phase I Study of Vaccination With MUC-1 Antigen and Immunologic Adjuvant SB AS-2 in Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer
For Condition: stage 4A pancreatic cancer,stage 2 pancreatic cancer,stage 3 pancreatic cancer,stage 1 pancreatic cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , University of Pittsburgh Cancer Institute
Synopsis: Patient Abstract available in the near future.
Details: OBJECTIVES: I. Determine the safety and toxicity of vaccination with MUC-1 antigen and immunologic adjuvant SB AS-2 in patients with resected or locally advanced unresectable pancreatic cancer. II. Determine the maximum tolerated dose and/or recommended phase II dose of MUC-1 antigen in this patient population. III. Determine the qualitative and quantitative tumor response to this treatment in these patients. IV. Determine the disease-free survival in resected patients, progression-free survival in locally advanced unresectable patients, and overall survival in all patients receiving this treatment. PROTOCOL OUTLINE: This is a dose escalation study of MUC-1 antigen. Patients receive vaccination with MUC-1 antigen and immunologic adjuvant SB AS-2 intramuscularly on day 1. Treatment repeats every 3 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 1 year after the last vaccination, patients without recurrent disease may receive booster vaccines annually. Cohorts of 4 to 8 patients receive escalating doses of MUC-1 antigen until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 4 or 2 of 8 patients experience dose-limiting toxicity. Patients are followed at 2 weeks. PROJECTED ACCRUAL: A total of 15-20 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed resected or locally advanced unresectable pancreatic cancer - No metastases --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy - Endocrine therapy: No concurrent glucocorticosteroids - Radiotherapy: No prior radiotherapy - Surgery: At least 3 weeks since prior resection of pancreatic cancer - Other: No concurrent non-steroidal anti-inflammatory drugs (NSAIDs) --Patient Characteristics-- - Age: Over 18 - Performance status: ECOG 0-2 - Life expectancy: At least 4 months - Hematopoietic: WBC greater than 3,500/mm3; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin no greater than 2.0 mg/dL - Renal: Creatinine no greater than 1.5 mg/dL - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective double barrier contraception 1 week before, during, and for at least 2 weeks after study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RameshRamanathan, Study Chair, University of Pittsburgh Cancer Institute
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
United States
Additional Information:
Study ID Numbers: CDR0000068375; PCI-97-046,NCI-G00-1888,PCI-IRB-970871
Study Start Date: May 1998
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00008099
Other Stage 3 Pancreatic Cancer Studies:
1. Fluorouracil, External-Beam Radiation Therapy, and Gemcitabine With or Without Brachytherapy Using Phosphorus P32 in Treating Patients With Locally or Regionally Advanced Unresectable Adenocarcinoma of the Pancreas
2. Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer
3. Flavopiridol Plus Radiation Therapy Followed By Gemcitabine in Treating Patients With Locally Advanced, Unresectable Pancreatic Cancer
4. Gene Therapy Combined With Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer That Cannot Be Surgically Removed
5. Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer
Related Studies:
Other stage 3 pancreatic cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Phase I Study of Vaccination With MUC-1 Antigen and Immunologic Adjuvant SB AS-2 in Patients With Resected or Locally Advanced Unresectable Pancreatic Cancer
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