Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer

Phase 1TerminatedNCT00072098

Max Sung22 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer Metastatic Cancer

Interventions

adenovirus vectorBIOLOGICAL

interleukin-12 geneBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Outcomes

Primary Outcomes

safety measure

adverse event reporting

Time frame: up to day 57

toxicity grading

toxicity will assessed from grades 0 to 4 as per common toxicity criteria

Time frame: up to day 57

Secondary Outcomes

tumor response compared at four weeks to baseline

tumor masses enumerated and measured pre-treatment and 4 weeks after treatment and changes in the tumor calculated.

Time frame: baseline and four weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.