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Vaccine Therapy in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian 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 in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian Cancer Clinical research trials and Vaccine Therapy in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian 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 in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian Cancer. Vaccine Therapy in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian 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 in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Vaccine Therapy in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian 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 in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian Cancer  Vaccine Therapy in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian Cancer
Vaccine Therapy in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian Cancer
For Condition: Non-small cell lung cancer,adult brain tumor,Prostate Cancer,Gastric Cancer,ovarian epithelial cancer
Status: Recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made from a peptide may make the body build an immune response to kill cancer cells. PURPOSE: Phase I trial to compare two different vaccines in treating patients who have gastric cancer, non-small cell lung cancer, prostate, or ovarian cancer.
Details: OBJECTIVES: - Determine the toxicity of EGFRvIII peptide vaccine with sargramostim (GM-CSF) or keyhole limpet hemocyanin (KLH) as adjuvant in patients with EGFRvIII-expressing cancer. - Determine the preexisting antibody and T-cell responses to EGFRvIII in these patients. - Determine the antibody and T-cell responses to EGFRvIII peptide after immunization with this vaccine with GM-CSF or KLH as adjuvant. OUTLINE: Patients are assigned to one of two treatment arms. - Arm I: Patients receive a vaccine containing EGFRvIII peptide admixed with sargramostim (GM-CSF) intradermally monthly. - Patients receive a vaccine containing EGFRvIII peptide admixed with keyhole limpet hemocyanin subcutaneously monthly. Treatment in both arms continues for 6 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 30 patients (15 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed diagnosis of one the following: - Stage II-III gastric cancer - Stage II-IIIA non-small cell lung cancer - Stage IIC-IV ovarian cancer in first complete remission - CA 125 normal and stable* - Grade III anaplastic astrocytoma - Stage IV (M1) prostate adenocarcinoma - No small cell variations - Must be receiving androgen blockade - Prostate-specific antigen less than 5 ng/mL and stable* - Documented EGFRvIII expression in primary tumor - Must have received prior surgery and or chemoradiotherapy for disease (except prostate cancer patients) NOTE: *Stable defined as no increase over 2 measurements at least 28 days apart with the last measurement within the past 28 days PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Zubrod 0 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 10 g/dL Hepatic: - SGOT no greater than 2.5 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2.5 times ULN - No hepatitis Renal: - Not specified Other: - No other malignancy in the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission - No contraindication to receiving sargramostim (GM-CSF) or KLH-based vaccine products - No autoimmune disease - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - See Disease Characteristics - At least 1 month since prior cytotoxic chemotherapy - No concurrent chemotherapy Endocrine therapy: - See Disease Characteristics - At least 1 month since prior treatment dose corticosteroids - No concurrent corticosteroids Radiotherapy: - See Disease Characteristics - No concurrent radiotherapy Surgery: - See Disease Characteristics Other: - Recovered from all prior therapies - No concurrent enrollment on other phase I studies - No other concurrent immune modulators
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RobertMontgomery, Study Chair, Veterans Affairs Medical Center - Seattle
University of Washington School of Medicine *Recruiting*
Seattle, Washington, 98195-6527
United States
Recruiting Mary (Nora) Disis 206-616-1823
Veterans Affairs Medical Center - Seattle *Recruiting*
Seattle, Washington, 98108
United States
Recruiting Robert Montgomery 206-277-6878
Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi, Mississippi, 39531-2410
United States
Recruiting Robert Veith 504-568-5151
Additional Information:
Study ID Numbers: CDR0000068824; SWOG-S0114,UW-106,NCI-V01-1664
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00023634
Other Prostate Cancer Studies:
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2. Biological Therapy Following Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Cancer
3. Clinical Trial to Screen Participants Who Are at High Genetic Risk for Ovarian Cancer
4. Screening Women at High Genetic Risk for Ovarian Cancer
5. Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment
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Vaccine Therapy in Treating Patients With Gastric Cancer, Non-Small Cell Lung Cancer, Prostate, or Ovarian Cancer
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