Clinical trial NCT00072098: Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Colorectal Cancer
Metastatic Cancer
Keywords: stage IV colon cancer
stage IV rectal cancer
liver metastases
recurrent rectal cancer
recurrent colon cancer
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-11-06
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: safety measure
timeFrame: up to day 57
measure: toxicity grading
timeFrame: up to day 57
Secondary outcomes:
measure: tumor response compared at four weeks to baseline
timeFrame: baseline and four weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Max W. Sung, MD
role: PRINCIPAL_INVESTIGATOR
References: