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Biological Therapy in Treating Patients With Metastatic Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Biological Therapy in Treating Patients With Metastatic Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Biological Therapy in Treating Patients With Metastatic Cancer Clinical research trials and Biological Therapy in Treating Patients With Metastatic Cancer healthcare trials happen in a lot of of localities 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 measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Biological Therapy in Treating Patients With Metastatic Cancer. Biological Therapy in Treating Patients With Metastatic Cancer Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Biological Therapy in Treating Patients With Metastatic Cancer clinical trial. Human subjects often receive the most effective healthcare possible for their Biological Therapy in Treating Patients With Metastatic Cancer condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "B" Clinical Trials Conditions > Biological Therapy in Treating Patients With Metastatic Cancer  Biological Therapy in Treating Patients With Metastatic Cancer
Biological Therapy in Treating Patients With Metastatic Cancer
For Condition: Rectal Cancer,Pancreatic Cancer,Testicular Cancer,ovarian epithelial cancer,Breast Cancer,adult primary liver cancer,Colorectal Cancer,Thyroid Cancer,Colon Cancer,Gastric Cancer,Head and Neck Cancer,Lung Cancer,Salivary Gland Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Duke Comprehensive Cancer Center
Synopsis: RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I trial to study the effectiveness of biological therapy in treating patients who have metastatic cancer that has not responded to previous treatment.
Details: OBJECTIVES: I. Determine the safety and dose limiting toxicity of an intravenous vaccine of autologous, cultured, dendritic cells pulsed with carcinoembryonic antigen (CEA) RNA in patients with metastatic adenocarcinoma expressing CEA. II. Assess the cellular immune response to the CEA protein. III. Assess the clinical and biochemical response to the treatment and the duration of such response. PROTOCOL OUTLINE: This a three tiered, open label, uncontrolled, dose escalation study. The first 3 patients receive a low dose of intravenous carcinoembryonic antigen (CEA) RNA-pulsed autologous dendritic cells (DC) at weeks 0, 1, 2, and 3. Patients are evaluated for dose limiting toxicity (DLT), immune response, and the antitumor response for at least 1 week before dose escalation may proceed. If there is no DLT in the first three, the next 3 patients are treated at a medium dose of CEA RNA-pulsed autologous DC at 0, 1, 2, and 3 weeks. Finally, if DLT is not seen at the medium dose, the final 6 patients receive intravenous infusions of a high dose of CEA RNA-pulsed autologous DC at weeks 0, 1, 2, and 3. If 1-2 patient(s) experience DLT at the either the low or medium dose levels, 3 more patients are entered at the same dose. If no further DLT occurs, then dose escalation continues. As soon as 3 toxic events occur in 3-6 patients at one dose level, accrual at that level ceases. The MTD is defined as the dose level immediately below that at which more than 3 of 6 patients develop DLT. PROJECTED ACCRUAL: A minimum of 3 and a maximum of 18 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 metastatic adenocarcinoma expressing carcinoembryonic antigen (CEA) that has failed conventional therapy - Measurable or evaluable disease; May include elevated CEA level - No previously irradiated or known new CNS metastases --Prior/Concurrent Therapy-- - Must have recovered from all acute toxic effects - Biologic therapy: No concurrent biologic therapy; At least 6 weeks since biologic therapy; No concurrent immunotherapy No more than 1 prior biologic regimen - Chemotherapy: No concurrent chemotherapy; At least 6 weeks since chemotherapy; No more than 1 prior chemotherapy regimen - Endocrine therapy: At least 6 weeks since steroid therapy - Radiotherapy: No concurrent radiotherapy; At least 12 weeks since therapy including Sr 89; At least 6 weeks since other radiotherapy; No prior cranial radiotherapy - Surgery: Not specified - Other: No concurrent immunosuppressives such as azathioprine or cyclosporine --Patient Characteristics-- - Age: 18 and over - Performance status: Karnofsky 70-100% - Life expectancy: Greater than 6 months - Hematopoietic: WBC at least 3,000/mm3; Absolute lymphocyte count at least 1,000/mm3; Hemoglobin at least 9 g/dL; Platelet count at least 100,000/mm3; PT less than 1.25 times normal limit; PTT less that 1.66 times normal limit; Fibrinogen greater than 0.75 times normal limit - Hepatic: Bilirubin less than 2.0 mg/dL - Renal: Creatinine less than 2.5 mg/dL - Cardiovascular: No NYHA class III or IV - Pulmonary: FEV1 greater than 70% of predicted; FVC greater than 70% of predicted DLCO greater than 70% of predicted; No asthma or chronic obstructive pulmonary disease - Other: No active or chronic infection (including urinary tract infection); No viral hepatitis; HIV negative; No concurrent second malignancy other than nonmelanoma skin cancer or controlled superficial bladder cancer; No hepatic disease; No history of other autoimmune disease such as inflammatory bowel disease, systemic lupus erythematous, ankylosing spondylitis, scleroderma, or multiple sclerosis
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HerbertLyerly, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Additional Information:
Study ID Numbers: CDR0000065619; DUMC-96098,NCI-G97-1272,DUMC-1817-99-10R3
Study Start Date: February 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004604
Other Rectal Cancer Studies:
1. Computed Tomographic Colonography in Detecting Colorectal Polyps or Cancer
2. Monoclonal Antibody Therapy and/or Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
3. Endoscopic Placement of Metal Stent in Patients With Cancer-Related Bowel Obstruction
4. DJ-927 as Second-Line Therapy in Treating Patients With Progressive Locally Advanced or Metastatic Colorectal Adenocarcinoma
5. Epothilone D as Second-Line Treatment for Patients With Advanced or Metastatic Refractory Colorectal Cancer
Related Studies:
Other Rectal Cancer Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Biological Therapy in Treating Patients With Metastatic Cancer
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