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Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer Clinical Trials Data presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, calls or treatment using a genuine doctor. We are not docs. Always consult your dr. on Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer conditions. Clinical Trials Search.org is a site 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 healthcare trials occur in a lot of of places throughout the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the potency of new drugs. The intent of the studies / undertakings is to figure out certain human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector corporations to locate remedies for all kinds 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 allow volunteers to obtain health treatment alternatives before they are available to the masses. Many times the participants undergo treatment for free, 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 typically obtain the most effective healthcare available for their Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer condition. Dangers are a reality, nonetheless, and can include extra or frequent mD trips, medical hazards (potentially life-endangering), and/or the treatment being uneffective. Trials are federally regulated with rigid guidelines to protect clinical trials patients.
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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 Recurrent Colon Cancer Studies:
1. Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer
2. Irinotecan With or Without Oxaliplatin in Treating Patients With Metastatic Colorectal Cancer
3. Surgery With or Without Thalidomide in Treating Patients With Recurrent or Metastatic Colorectal Cancer
4. Irinotecan and Cyclosporine in Treating Patients With Metastatic, Advanced or Locally Recurrent Colorectal Cancer
5. Bevacizumab in Treating Patients With Metastatic Breast or Colorectal Cancer Who Received Bevacizumab on a Phase II or Phase III Clinical Trial
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Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer
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