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Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer Clinical research trials and Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer. Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer clinical trial. Human subjects often get the best healthcare available for their Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer  Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer
Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer
For Condition: stage 3 pancreatic cancer,recurrent pancreatic cancer,stage 4B pancreatic cancer,stage 2 pancreatic cancer,adenocarcinoma of the pancreas,stage 4A pancreatic cancer
Status: Completed
Sponsor(s): St. Vincent Medical Center - Los Angeles ,
Synopsis: RATIONALE: Vaccines made from donated tumor cells treated with interferon alfa may make the body build an immune response to and kill pancreatic tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors may help a person's immune system recover from the side effects of chemotherapy. Combining these treatments may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining vaccine therapy using donated tumor cells treated with interferon alfa and radiation therapy and cyclophosphamide plus GM-CSF in treating patients with advanced pancreatic cancer.
Details: OBJECTIVES: I. Determine the feasibility, toxicity, and antitumor effects of active specific intralymphatic immunotherapy with allogeneic pancreatic cancer cells treated with interferon alfa plus low-dose adjuvant systemic sargramostim (GM-CSF) and cyclophosphamide in patients with incurable pancreatic adenocarcinoma. II. Assess the immunologic and biologic correlates of this treatment regimen in these patients. PROTOCOL OUTLINE: Cultured allogeneic pancreatic cancer cells are incubated with interferon alfa for 72-96 hours. Autologous cell lines, if established, may be used as an alternative. The cells are irradiated immediately prior to use. Patients receive cyclophosphamide IV on day -3 and sargramostim (GM-CSF) subcutaneously on days 0-8. On day 0, patients receive viable tumor cells via dorsal pedal lymphatic cannulation. Treatment repeats every 2-4 weeks for a minimum of 8 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 2-4 months. PROJECTED ACCRUAL: A total of 14 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 adenocarcinoma of the pancreas that is locoregionally active or metastatic and not amenable to cure or long-term control by surgery, radiotherapy, or chemotherapy - No brain metastases refractory to irradiation or surgery --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy - Endocrine therapy: No concurrent chronic steroid therapy - Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy - Surgery: See Disease Characteristic - Other: At least 4 weeks since other prior therapy --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-3 OR Karnofsky 60-100% - Life expectancy: At least 3 months - Hematopoietic: Not specified - Hepatic: Not specified - Renal: Not specified - Cardiovascular: No prior or concurrent significant cardiovascular disease - Pulmonary: No prior or concurrent significant pulmonary disease - Other: No AIDS; HIV negative; No prior or concurrent autoimmune disease; No other concurrent major medical illness; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesWiseman, Study Chair, St. Vincent Medical Center - Los Angeles
St. Vincent Medical Center - Los Angeles
Los Angeles, California, 90057
United States
Additional Information:
Study ID Numbers: CDR0000064749; SVMC-ONC-222P,NCI-V96-0886
Study Start Date: May 1996
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002773
Other Stage 4b Pancreatic Cancer Studies:
1. Paclitaxel and Bryostatin-1 in Treating Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer
2. Combination Chemotherapy and Radiation Therapy in Treating Patients With Pancreatic Cancer
3. Surgery Followed by Radiation Therapy and Chemotherapy in Treating Patients With Cancer of the Pancreas
4. Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
5. Fluorouracil Plus Radiation Therapy Following Surgery in Treating Patients With Pancreatic Cancer
Related Studies:
Other stage 4B pancreatic cancer Clinical Trials
Other California Clinical Trials
Other Los Angeles Clinical Trials
Vaccine Therapy, Chemotherapy, and GM-CSF in Treating Patients With Advanced Pancreatic Cancer
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