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

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Primary Purpose

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

adenovirus vector

interleukin-12 gene

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, stage IV rectal cancer, liver metastases, recurrent rectal cancer, recurrent colon cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Icahn School of Medicine at Mount Sinai

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental Group

Arm Description

Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene

Outcomes

Primary Outcome Measures

safety measure

adverse event reporting

toxicity grading

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00072098

First Posted

November 4, 2003

Last Updated

January 10, 2017

Sponsor

Max Sung

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00072098

Brief Title

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

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Terminated

Why Stopped

limited funding

Study Start Date

September 2003 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Max Sung

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colorectal Cancer, Metastatic Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental Group

Arm Type

Experimental

Arm Description

Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene

Intervention Type

Biological

Intervention Name(s)

adenovirus vector

Intervention Type

Biological

Intervention Name(s)

interleukin-12 gene

Primary Outcome Measure Information:

Title

safety measure

Description

adverse event reporting

Time Frame

up to day 57

Title

toxicity grading

Description

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

Time Frame

up to day 57

Secondary Outcome Measure Information:

Title

tumor response compared at four weeks to baseline

Description

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

Time Frame

baseline and four weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Max W. Sung, MD

Organizational Affiliation

Icahn School of Medicine at Mount Sinai

Official's Role

Principal Investigator

Facility Information:

Facility Name

Icahn School of Medicine at Mount Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Colorectal Cancer, Metastatic Cancer

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial