Expired Study
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New York, New York 10029


Purpose:

RATIONALE: Inserting the interleukin-12 gene into a person's cancer cells may make the body build an immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of interleukin-12 gene when injected into the tumors of patients with liver metastases secondary to colorectal cancer.


Study summary:

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.


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 immunosuppressive drugs - No concurrent immunosuppressive drugs - No concurrent anticoagulant therapy with heparin or warfarin


NCT ID:

NCT00072098


Primary Contact:

Principal Investigator
Max W. Sung, MD
Icahn School of Medicine at Mount Sinai


Backup Contact:

N/A


Location Contact:

New York, New York 10029
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 14, 2017

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