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

• Sponsor: Max Sung (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00072098
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 22
• Location: 1
• Arm: 1
• Duration (Months): 100
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer; Metastatic Cancer	Biological: adenovirus vector; Biological: interleukin-12 gene	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: 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
• Study Start Date: Sep 1, 2003
• Actual Primary Completion Date: Jan 1, 2012
• Actual Study Completion Date: Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental Group Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene	Biological: adenovirus vector; Biological: interleukin-12 gene

Outcome Measures

Primary Outcome Measures

1. safety measure [up to day 57]

   adverse event reporting

2. toxicity grading [up to day 57]

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

Secondary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

• Max Sung
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Max W. Sung, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Max Sung, Associate Professor, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT00072098
• Other Study ID Numbers: GCO 97-0564; MTS-GCO-975642; MTS-GCO-971592; CDR0000335463; NIH 9911-359
• First Posted: Nov 6, 2003
• Last Update Posted: Jan 11, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by Max Sung, Associate Professor, Icahn School of Medicine at Mount Sinai: stage IV colon cancer; stage IV rectal cancer; liver metastases; recurrent rectal cancer; recurrent colon cancer
• Additional relevant MeSH terms: Colorectal Neoplasms; Interleukin-12

Study Results

No Results Posted as of Jan 11, 2017