|
Vaccine Therapy in Treating Patients With Metastatic Solid Tumors Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Vaccine Therapy in Treating Patients With Metastatic Solid Tumors conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Vaccine Therapy in Treating Patients With Metastatic Solid Tumors Clinical research trials and Vaccine Therapy in Treating Patients With Metastatic Solid Tumors health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Vaccine Therapy in Treating Patients With Metastatic Solid Tumors. Vaccine Therapy in Treating Patients With Metastatic Solid Tumors Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Vaccine Therapy in Treating Patients With Metastatic Solid Tumors clinical trial. Human subjects often get the best healthcare available for their Vaccine Therapy in Treating Patients With Metastatic Solid Tumors condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "V" Clinical Trials Conditions > Vaccine Therapy in Treating Patients With Metastatic Solid Tumors  Vaccine Therapy in Treating Patients With Metastatic Solid Tumors
Vaccine Therapy in Treating Patients With Metastatic Solid Tumors
For Condition: unspecified adult solid tumor, protocol specific
Status: Recruiting
Sponsor(s): Herbert Irving Comprehensive Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Infusing the vaccine directly into a tumor may cause a stronger immune response and kill more tumor cells. It is not yet known which vaccine may be more effective in treating metastaticsolid tumors. PURPOSE: Randomizedphase I trial to compare the effectiveness of two different vaccines given directly into the tumor in treating patients who have metastatic solid tumors.
Details: OBJECTIVES: - Compare the feasibility of intratumoral administration of rF-B7.1 vaccine vs recombinant fowlpox-TRICOM vaccine in patients with cutaneous, subcutaneous, or lymph node metastatic solid tumors. - Compare the feasibility of intratumoral administration of these vaccines in patients with visceral metastatic solid tumors. - Compare the clinical toxicity of these vaccines in these patients. - Determine the optimal dose of these vaccines in these patients. - Compare the clinical response of patients treated with these vaccines. - Compare the safety profiles of these vaccines in these patients. - Determine the quality of life of patients treated with these vaccines. - Determine the anti-tumor immune reactivity in patients treated with these vaccines. OUTLINE: This is a randomized study with dose-escalation component. Patients are stratified according to tumor location (cutaneous, subcutaneous, or lymph node metastases vs visceral metastases). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive rF-B7.1 vaccine intratumorally on day 1. - Arm II: Patients receive fowlpox-TRICOM vaccine intratumorally on day 1. Treatment in both arms repeats every 4 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease may receive additional courses. Three patients from the cutaneous disease (CD) stratum are treated at low-dose in each treatment arm. If no more than 1 of 6 patients experience dose-limiting toxicity (DLT), then 6 additional CD patients are randomized to high-dose treatment. If no more than 1 of these 6 patients experience DLT, then 12 patients from the visceral disease (VD) stratum are randomized to low-dose treatment. If no more than 2 of 12 VD patients experience DLT, then the next cohort of 12 VD patients is randomized to high-dose treatment. If 3 of the original 12 VD patients experience DLT, then 6 additional VD patients receive low-dose treatment. If no more than 3 of 18 patients experience DLT, then 12 VD patients receive high-dose treatment. Quality of life is assessed at baseline, monthly during therapy, and then at the end of therapy. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 42 patients (21 per treatment arm; 12 in the cutaneous stratum and 30 in the visceral stratum) will be accrued for this study within 1-2 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed metastatic unresectable solid tumors - Cutaneous, subcutaneous, lymph node, or visceral tumors that are accessible to imaging and injections - No standard therapy available - At least 1 unidimensionally measurable lesion - At least 20 mm for visceral lesions - At least 10 mm for cutaneous, subcutaneous, and nodal lesions - No untreated or edematous metastatic brain lesions - At least 6 weeks since prior surgery and/or radiotherapy for brain metastases and no evidence of disease or edema on CT scan or MRI - No ascites or pleural effusions - No leptomeningeal disease PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - More than 3 months Hematopoietic: - Absolute granulocyte count at least 3,000/mm^3 - Platelet count at least 100,000/mm^3 - No bleeding diathesis Hepatic: - Bilirubin no greater than 1.5 mg/dL* - SGOT/SGPT no greater than 2 times upper limit of normal (ULN)* - Alkaline phosphatase no greater than 2 times ULN* - No elevated PT or PTT - No cirrhosis - No active hepatitis - No hepatic insufficiency NOTE: * Unless due to metastases Renal: - Creatinine no greater than 2.0 mg/dL - No renal insufficiency Pulmonary: - No chronic obstructive pulmonary disorder Immunologic: - No active autoimmune disorders - No active immunologically mediated disease (e.g., severe psoriasis, colitis, idiopathic thrombocytopenic purpura, multiple sclerosis, connective tissue disease, or active rheumatoid arthritis) - No significant allergy or hypersensitivity to eggs Other: - No active seizure disorder - No active or chronic infections - No other significant medical disease that would preclude study participation - No other malignancy within the past 5 years except stage I cervical cancer or basal cell carcinoma - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - More than 8 weeks since prior immunotherapy and recovered Chemotherapy: - More than 4 weeks since prior chemotherapy and recovered Endocrine therapy: - At least 4 weeks since prior systemic corticosteroids - No concurrent corticosteroids Radiotherapy: - See Disease Characteristics - More than 2 weeks since prior radiotherapy and recovered - No evidence of bone marrow toxicity from prior radiotherapy Surgery: - See Disease Characteristics - More than 4 weeks since prior surgery and recovered
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HowardKaufman, Study Chair, Columbia University
Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City, New York, 10032
United States
Recruiting Howard Kaufman 212-342-6042
Additional Information:
Study ID Numbers: CDR0000069189; NCI-3351,AECM-01-122,CPMC-IRB-14535,CPMC-IRB-01-122
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00030693
Other Unspecified Adult Solid Tumor, Protocol Specific Studies:
1. Bryostatin 1 Plus Cisplatin in Treating Patients With Metastatic or Unresectable Cancer
2. BMS-184476 in Treating Patients With Advanced Solid Tumors
3. Neoadjuvant Tipifarnib, Docetaxel, and Capecitabine in Treating Patients With Locally Advanced or Metastatic Solid Tumors or Stage IIIA or Stage IIIB Breast Cancer
4. Tirapazamine, Carboplatin, and Paclitaxel in Treating Patients With Advanced Malignant Solid Tumors
5. Oxaliplatin and Paclitaxel in Treating Patients With Metastatic or Unresectable Cancer
Related Studies:
Other unspecified adult solid tumor, protocol specific Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Vaccine Therapy in Treating Patients With Metastatic Solid Tumors
|
|
|
|
|
|
|
|
