Colorectal Cancer, Metastatic Cancer
Conditions
Keywords
stage IV colon cancer, stage IV rectal cancer, liver metastases, recurrent rectal cancer, recurrent colon cancer
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 best dose of interleukin-12 gene when injected into the tumors of patients with liver metastases secondary to colorectal cancer.
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 . * Determine the tumor response in patients treated with this regimen. * Determine the immune response in patients treated with this regimen.
Interventions
BIOLOGICALadenovirus vector
BIOLOGICALinterleukin-12 gene
Sponsors
National Cancer Institute (NCI)
Max Sung
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety measure | up to day 57 | adverse event reporting |
| toxicity grading | up to day 57 | toxicity will assessed from grades 0 to 4 as per common toxicity criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tumor response compared at four weeks to baseline | baseline and four weeks | tumor masses enumerated and measured pre-treatment and 4 weeks after treatment and changes in the tumor calculated. |
Countries
United States
Outcome results
None listed