Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Max Sung
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
