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Biological Therapy in Treating Patients With Advanced 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 Biological Therapy in Treating Patients With Advanced Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Biological Therapy in Treating Patients With Advanced Cancer Clinical research trials and Biological Therapy in Treating Patients With Advanced 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 Biological Therapy in Treating Patients With Advanced Cancer. Biological Therapy in Treating Patients With Advanced 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 Biological Therapy in Treating Patients With Advanced Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Biological Therapy in Treating Patients With Advanced 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 > "B" Clinical Trials Conditions > Biological Therapy in Treating Patients With Advanced Cancer  Biological Therapy in Treating Patients With Advanced Cancer
Biological Therapy in Treating Patients With Advanced Cancer
For Condition: stage 3 gastric cancer,stage 3A breast cancer,stage 4 gastric cancer,stage 3 ovarian epithelial cancer,stage 4 ovarian epithelial cancer,stage 2 gastric cancer,stage 3B breast cancer,stage 2 breast cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Duke Comprehensive Cancer Center
Synopsis: RATIONALE: A person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have advanced cancer that shows no signs of disease following treatment.
Details: OBJECTIVES: I. Evaluate the immune response of patients with HER2/neu expressing advanced malignancies showing no evidence of disease after standard treatment when injected with HER2/neu intracellular domain protein pulsed autologous dendritic cells. II. Assess time to recurrence in these patients. PROTOCOL OUTLINE: Autologous dendritic cells (DC) are pulsed with HER2/neu intracellular domain protein (ICD). The pulsed DC are administered subcutaneously (SQ) and intradermally, followed by autologous DC mixed with tetanus toxoid (TT) and autologous DC mixed with keyhole limpet hemocyanin (KLH) SQ and intradermally on day 1. HLA-A2 positive patients also receive autologous DC mixed with CMV pp65 peptide SQ and intradermally on day 1. Treatment continues every 3 weeks for a total of 4 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year or until disease progression. PROJECTED ACCRUAL: A total of 6 patients will be accrued for this study over 6 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed advanced malignancy that expresses HER2/neu - Stage IIA breast cancer with more than 6 positive lymph nodes - Stage IIB, IIIA, or IIIB breast cancer - Stage III ovarian cancer - Lymph node positive gastric cancer - Metastatic tumor No measurable or evaluable disease after standard treatment No previously irradiated or newly diagnosed CNS metastases Hormone receptor status: Not specified --Prior/Concurrent Therapy-- Biologic therapy: No other concurrent immunotherapy Chemotherapy: - At least 4 weeks since prior chemotherapy and recovered - No concurrent chemotherapy Endocrine therapy: - Concurrent hormonal therapy allowed (tamoxifen, raloxifene, toremifene, and all aromatase inhibitors) - At least 4 weeks since prior steroid or immunosuppressive therapy (e.g, azathioprine or cyclosporine) Radiotherapy: - Prior radiotherapy allowed except to cranium - At least 4 weeks since prior radiotherapy and recovered - At least 12 weeks since prior strontium chloride Sr 89 - No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery and recovered Other: - Concurrent bisphosphonates allowed - No prior hepatitis B immunization --Patient Characteristics-- Age: 18 and over Menopausal status: Not specified Performance status: Karnofsky 80-100% Life expectancy: Greater than 6 months Hematopoietic: - WBC at least 3,000/mm3 - Hemoglobin at least 9 mg/dL - Platelet count at least 100,000/mm3 Hepatic: - Bilirubin less than 2.0 mg/dL - No hepatic disease, including viral hepatitis Renal: Creatinine less than 2.5 mg/dL Cardiovascular: No New York Heart Association class III or IV heart disease Pulmonary: No asthma or chronic obstructive pulmonary disease Immunologic: - Must have positive intradermal delayed hypersensitivity test for at least 1 of the following: *Candida *Mumps *Tetanus *Trichophyton *Histoplasmin - No prior autoimmune disease including, but not limited to, the following: *Inflammatory bowel disease *Systemic lupus erythematosus *Ankylosing spondylitis *Scleroderma *Multiple sclerosis Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - HIV negative - Hepatitis B surface antigen and hepatitis C antibody negative - No other concurrent serious chronic or acute illness or infection (including urinary tract infection) - No known shellfish or iodine allergy - No other prior or concurrent malignancy except for nonmelanoma skin cancer, cervical cancer, or controlled superficial bladder cancer - No medical or psychological condition that may preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MichaelMorse, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: CDR0000067937; NCI-G00-1800,DUMC-1528-99-9,DUMC-1309-00-7R1
Study Start Date: February 2000
Record last reviewed: May 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005956
Other Stage 3a Breast Cancer Studies:
1. Genetic Study in Patients with Advanced Epithelial Ovarian Cancer
2. Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
3. Radiolabeled Monoclonal Antibody Therapy in Treating Patients With Advanced Ovarian Epithelial Cancer
4. Paclitaxel and Carboplatin With or Without Epirubicin in Treating Patients With Stage IIB, Stage III, or Stage IV Invasive Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer
5. BMS-247550 in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
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Biological Therapy in Treating Patients With Advanced Cancer
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