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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00072098
• Other study ID #: GCO 97-0564
• Secondary ID: MTS-GCO-975642MT
• Status: Terminated
• Phase: Phase 1
• First received: November 4, 2003
• Last updated: January 10, 2017
• Start date: September 2003
• Est. completion date: January 2012

Study information

• Verified date: January 2017
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Biological:
• adenovirus vector

• interleukin-12 gene

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Max Sung	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety measure	adverse event reporting	up to day 57	Yes
Primary	toxicity grading	toxicity will assessed from grades 0 to 4 as per common toxicity criteria	up to day 57	Yes
Secondary	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.	baseline and four weeks	No