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Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer Clinical research trials and Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer. Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer  Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer
Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer
For Condition: stage 4 breast cancer,stage 4 ovarian epithelial cancer,stage 3B breast cancer,stage 3A breast cancer,adenocarcinoma of the lung,stage 4 non-small cell lung cancer,stage 3 non-small cell lung cancer,stage 3 ovarian epithelial cancer
Status: Completed
Sponsor(s): University of Washington ,
Synopsis: RATIONALE: Vaccines may make the body build an immune response to tumor cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus sargramostim in treating patients who have stage III or stage IV cancer.
Details: OBJECTIVES: I. Determine the safety of serial intradermal or subcutaneous vaccinations of HER-2 derived p369-377 peptide incorporated into polylactide-co-glycolide (PLG) microspheres with adjuvant sargramostim (GM-CSF) in patients with stage III or IV HER-2 expressing cancers. II. Determine whether cytotoxic T lymphocytes (CTL) specific for the HER-2 protein can be elicited in patients with HLA-A2 by immunization with this regimen. III. Determine which route of immunization, intradermal or subcutaneous, is more effective in generating HER-2 specific CTL in these patients on this regimen. IV. Determine the extent to which escalated dose of PLG peptide affects the immune response in these patients on this regimen. PROTOCOL OUTLINE: Patients undergo leukapheresis prior to study and after final vaccination. Patients are sequentially entered into one of three treatment arms: Arm I: Patients receive an intradermal vaccination of HER-2 derived p369-377 peptide incorporated into polylactide-co-glycolide (PLG) microspheres with adjuvant sargramostim (GM-CSF). Arm II: Patients receive a subcutaneous vaccination of HER-2 derived p369-377 peptide incorporated into PLG microspheres with adjuvant GM-CSF. Arm III: Patients receive a higher dose of subcutaneous vaccination of HER-2 derived p369-377 peptide incorporated into PLG microspheres with adjuvant GM-CSF. Treatment repeats every 4 weeks for up to 6 courses in the absence of unacceptable toxicity. PROJECTED ACCRUAL: A total of 15 patients (5 per treatment arm) 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-- - Stage III adenocarcinoma that overexpresses HER-2 and previously treated by surgical resection, conventional chemotherapy, or radiotherapy OR Stage IV adenocarcinoma that overexpresses HER-2 and in stable or complete remission with no other concurrent chemotherapy - Must have documented HER-2 protein overexpression in the primary or metastatic tumor - HLA-A2 positive --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; At least 4 weeks since prior cytotoxic chemotherapy - Endocrine therapy: At least 4 weeks since prior corticosteroids - Radiotherapy: See Disease Characteristics - Surgery: See Disease Characteristics - Other: No other concurrent investigational phase I studies --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 90-100% - Life expectancy: At least 12 months - Hematopoietic: WBC greater than 3,500/mm3; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin less than 1.5 mg/dL - Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min - Other: Female patients must have completed childbearing; Fertile male patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
Mary(Nora) Disis, Study Chair, University of Washington
University of Washington School of Medicine
Seattle, Washington, 98195
United States
Additional Information:
Study ID Numbers: CDR0000067339; UWASH-103,NCI-V99-1574
Study Start Date: March 1999
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005023
Other Adenocarcinoma Of The Lung Studies:
1. Polyglutamate Paclitaxel Compared With Docetaxel in Treating Patients With Progressive Non-Small Cell Lung Cancer
2. Phase II Study of TLK286 in Patients With Advanced Non-Small Cell Lung Cancer
3. ZD1839 Plus Combination Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
4. Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer
5. ZD1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
Related Studies:
Other adenocarcinoma of the lung Clinical Trials
Other Washington Clinical Trials
Other Seattle Clinical Trials
Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer
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