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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 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 Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer conditions. Clinical Trials Search.org is a site devoted 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 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 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 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 Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible 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 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 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 Stage 4 Non-Small Cell Lung Cancer Studies:
1. Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Cancer
2. Standard Therapy Given With or Without Combination Chemotherapy in Treating Patients With Non-small Cell Lung Cancer
3. Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
4. Chemotherapy Plus Radiation Therapy in Treating Patients With Stage I, Stage II, or Stage III Non-small Cell Lung Cancer That Cannot Be Surgically Removed
5. Combination Chemotherapy Compared With No Treatment Following Surgery in Treating Patients With Non-small Cell Lung Cancer
Related Studies:
Other stage 4 non-small cell lung cancer 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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