Phase I Trial Of Adenoviral Vector Delivery Of The Human Interleukin-12 cDNA By Intratumoral Injection In Patients With Metastatic Colorectal Cancer To The Liver
adenovirus vector
+ interleukin-12 gene
Colonic Diseases+8
+ Digestive System Diseases
+ Digestive System Neoplasms
Treatment Study
Summary
Study start date: September 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.22 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location