Status:
TERMINATED
Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer
Lead Sponsor:
Max Sung
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Metastatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 ...
Detailed Description
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 . * De...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00072098
Start Date
September 1 2003
End Date
January 1 2012
Last Update
January 11 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029