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Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor about Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer Clinical research trials and Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer health trials happen in many of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms of circumstances, like Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer. Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer Clinical Trials and other clinical trials allow for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally there is a cost for a Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer clinical trial. Subjects frequently get the best healthcare possible for their Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.
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Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer  Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer
Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Duke Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines made from a person's white blood cells mixed with peptides may make the body build an immune response to kill cancer cells. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have refractorystage IV cancer.
Details: OBJECTIVES: - Determine the safety and feasibility of administering 1 or 2 courses of vaccination with carcinoembryonic antigen peptide 1-6D (CAP 1-6D)- and CMV pp65 peptide-pulsed autologous dendritic cells in patients with refractory stage IV CEA-expressing malignancies. - Determine the ability of this regimen to induce CAP 1-6D- and CMV pp65-specific T cells in these patients. - Determine the antitumor effect of this regimen, in terms of progression-free survival, of these patients. OUTLINE: This is an open-label, dose-escalation study. Patients undergo leukapheresis and collection of peripheral blood mononuclear cells from which dendritic cells (DC) are generated and pulsed with carcinoembryonic antigen peptide 1-6D (CAP 1-6D) and CMV pp65 peptide. Patients are assigned to 1 of 2 vaccination cohorts. - Cohort I: Patients receive vaccination with CAP 1-6D-pulsed DC and CMV pp65 peptide-pulsed DC subcutaneously and intradermally every 3 weeks for a total of 4 vaccinations. - Cohort II: Patients receive vaccinations as in cohort I every 3 weeks for a total of 8 vaccinations. If 1 of 6 patients in cohort II experience unacceptable toxicity, cohort I is determined to be the maximum tolerated regimen. Patients are followed every 3 months for 1 year. PROJECTED ACCRUAL: A total of 12 patients will be accrued for this study within 18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed malignancy that is refractory to standard therapy known to have a survival benefit - Stage IV disease - Carcinoembryonic antigen (CEA)-expressing tumor, as evidenced by 1 of the following: - Immunohistochemistry with at least 50% of the tumor with at least moderate intensity of staining - Peripheral blood CEA greater than 2.5 mg/dL - Tumor known to be universally CEA positive (i.e., colon or rectal cancer) - HLA-A201 positive - Measurable disease* - At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan NOTE: *Histologic or cytologic confirmation is not required for measurable disease restricted to a solitary lesion - Received at least 1 prior standard chemotherapy regimen known to have a survival benefit - Previously resected brain metastases allowed provided CT scan or MRI was performed within the past month and shows no metastasis PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Karnofsky 70-100% Life expectancy - More than 6 months Hematopoietic - WBC at least 3,000/mm^3 - Hemoglobin at least 9 g/dL (transfusions or red blood cell growth factors [e.g., epoetin alfa] allowed) - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin less than 2.0 mg/dL (unless patient has Gilbert's disease) - SGOT/SGPT less than 1.5 times upper limit of normal - No hepatic disease that would preclude study participation - No viral hepatitis (including chronic hepatitis) by hepatitis B surface antigen and hepatitis C serology Renal - Creatinine less than 2.5 mg/dL - No urinary tract infection Cardiovascular - No New York Heart Association class III or IV heart disease Immunologic - No history of autoimmune disease, including any of the following: - Inflammatory bowel disease - Systemic lupus erythematosus - Ankylosing spondylitis - Scleroderma - Multiple sclerosis - No active acute or chronic infection - HIV negative Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No other serious chronic or acute illness that would preclude study participation - No medical or psychological impediment that would preclude study compliance - No other malignancy within the past 5 years except nonmelanoma skin cancer, controlled carcinoma in situ of the cervix, or controlled superficial bladder cancer - No allergy to study vaccine components PRIOR CONCURRENT THERAPY: Biologic therapy - At least 4 weeks since prior immunotherapy - No other concurrent immunotherapy Chemotherapy - See Disease Characteristics - At least 4 weeks since prior chemotherapy - No concurrent chemotherapy Endocrine therapy - At least 6 weeks since prior steroid therapy (except steroids administered as premedication for chemotherapy or contrast-enhanced studies) - Concurrent hormonal therapy allowed for patients with breast cancer - No concurrent steroid therapy Radiotherapy - At least 4 weeks since prior radiotherapy - No concurrent radiotherapy Surgery - Not specified Other - Recovered from prior therapy - At least 4 weeks since prior investigational therapy - At least 4 weeks since other prior therapy - Any number of prior therapies are allowed - Concurrent bisphosphonates allowed for bone metastases - No concurrent immunosuppressive therapy (e.g., azathioprine or cyclosporine) - No other concurrent experimental therapies
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HerbertLyerly, Study Chair, Duke Comprehensive Cancer Center
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Herbert Lyerly 919-684-5613
Additional Information:
Study ID Numbers: CDR0000285629; DUMC-4180-02-10R0,NCI-5910
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057915
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Combination Chemotherapy in Treating Patients With Advanced Cancer
2. Flavopiridol and Irinotecan in Treating Patients With Advanced Solid Tumors
3. Docetaxel and GEM 231 in Treating Patients with Recurrent or Refractory Solid Tumors
4. 3-AP in Treating Patients With Advanced Cancer
5. MS 209 Plus Docetaxel in Treating Patients With Advanced Solid Tumors
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Vaccine Therapy in Treating Patients With Refractory Stage IV Cancer
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