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Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer Clinical research trials and Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer. Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "I" Clinical Trials Conditions > Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer  Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer
Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer
For Condition: Stage 4 rectal cancer,recurrent colon cancer,stage 4 colon cancer,liver metastases,recurrent rectal cancer
Status: Recruiting
Sponsor(s): Mount Sinai Medical Center ,
Synopsis: RATIONALE: Inserting the interleukin-12gene into a person's cancer cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of injecting the interleukin-12 gene into the tumors of patients who have liver metastasessecondary to colorectal cancer.
Details: OBJECTIVES: - Determine the toxicity and maximum tolerated dose of intratumoral adenoviral vector-delivered interleukin-12 gene in patients with liver metastases secondary to colorectal cancer . - Determine the tumor response in patients treated with this regimen. - Determine the immune response in patients treated with this regimen. OUTLINE: This is a dose-escalation study. Patients receive ultrasound-guided intratumoral injections of adenoviral vector-delivered interleukin-12 gene (ADV-hIL12) on day 1. Cohorts of 3-6 patients receive escalating doses of ADV-hIL12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at days 11, 15, 29, 43, and 57 and are then followed for survival thereafter. PROJECTED ACCRUAL: A total of 30-36 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed* colorectal adenocarcinoma metastatic to the liver - Solitary or multiple metastatic tumors in the liver - Metastatic involvement of the liver no greater than 40% of estimated liver volume NOTE: *Must be from the hepatic tumor designated for study injection - Metastatic liver tumors must be bidimensionally measurable by CT scan or MRI - At least 1 metastatic liver tumor measuring at least 2.0 cm must be visualized by ultrasound (US) and accessible for US-guided percutaneous injection - Extrahepatic metastases allowed - No prior or current ascites - Ineligible for hepatic resection PATIENT CHARACTERISTICS: Age - Adult Performance status - Karnofsky 70-100% Life expectancy - At least 16 weeks Hematopoietic - Granulocyte count at least 1,500/mm^3 - Hemoglobin at least 9.0 g/dL - Platelet count at least 100,000/mm^3 Hepatic - No clinical evidence of other severe liver disease (e.g., portosystemic encephalopathy) - PT no greater than 14 seconds - Bilirubin no greater than 2.0 times upper limit of normal (ULN) - Transaminases no greater than 2.5 times ULN Renal - Creatinine no greater than 1.5 mg/dL OR - Creatinine clearance at least 45 mL/min Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective nonhormonal contraception during and for at least 2 months after study participation - HIV negative - No active infection - No other concurrent serious medical illness - No other malignancy within the past 5 years except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, or grade 1 papillary bladder cancer - Oriented and rational - Weight at least 30 kg PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) Endocrine therapy - At least 2 months since prior corticosteroids Radiotherapy - Not specified Surgery - Not specified Other - At least 2 months since prior systemic immunosupppressive drugs - No concurrent immunosuppressive drugs
Total Enrollment:
Location and Contact Information:
Overall Study Official:
MaxSung, Principal Investigator, Mount Sinai Medical Center
Mount Sinai School of Medicine *Recruiting*
New York City, New York, 10029
United States
Recruiting Max Sung 212-241-6756
Additional Information:
Study ID Numbers: CDR0000335463; MTS-GCO-971592,MTS-GCO-975642
Study Start Date:
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00072098
Other Stage 4 Colon Cancer Studies:
1. Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation in Treating Men With Previously Untreated Germ Cell Cancer
2. Immunotherapy in Treating Patients With Resected Liver Metastases From Colon Cancer
3. Vaccine Therapy in Treating Patients With Colorectal Cancer Metastatic to the Liver
4. Surgery With or Without Combination Chemotherapy in Treating Patients With Liver Metastases from Colorectal Cancer
5. Diagnostic Procedure for Identifying Patients With Metastatic Colorectal Cancer
Related Studies:
Other stage 4 colon cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer
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