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

Sponsor:	Mount Sinai School of Medicine
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00072098

Purpose

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.

Condition	Intervention	Phase
Colorectal Cancer Metastatic Cancer	Biological: adenovirus vector Biological: interleukin-12 gene	Phase I

Study Type:	Interventional
Study Design:	Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Interleukin-12

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	36
Study Start Date:	September 2003

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.

OUTLINE: This is a dose-escalation study.

Patients receive ultrasound-guided intratumoral injections of adenoviral vector-delivered interleukin-12 gene (ADV-hIL12) on day 1.

Cohorts of 3-6 patients receive escalating doses of ADV-hIL12 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at days 11, 15, 29, 43, and 57 and are then followed for survival thereafter.

PROJECTED ACCRUAL: A total of 30-36 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 immunosupppressive drugs
No concurrent immunosuppressive drugs
No concurrent anticoagulant therapy with heparin or warfarin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00072098

Locations

United States, New York
Mount Sinai Medical Center	Recruiting
New York, New York, United States, 10029
Contact: Max W. Sung, MD 212-241-7902 max.sung@mssm.edu

Sponsors and Collaborators

Mount Sinai School of Medicine

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Max W. Sung, MD

Mount Sinai School of Medicine

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000335463, MTS-GCO-975642, MTS-GCO-971592
Study First Received:	November 4, 2003
Last Updated:	June 9, 2009
ClinicalTrials.gov Identifier:	NCT00072098 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IV colon cancer
stage IV rectal cancer
liver metastases
recurrent rectal cancer
recurrent colon cancer

Additional relevant MeSH terms:

Interleukin-12
Immunologic Factors
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Physiological Effects of Drugs
Rectal Diseases
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Neoplasm Metastasis
Angiogenesis Modulating Agents

Growth Inhibitors
Digestive System Neoplasms
Growth Substances
Adjuvants, Immunologic
Intestinal Diseases
Angiogenesis Inhibitors
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 25, 2009