NCT00072098

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1 colorectal-cancer

Timeline
Completed

Started Sep 2003

Longer than P75 for phase_1 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 6, 2003

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

January 11, 2017

Status Verified

January 1, 2017

Enrollment Period

8.3 years

First QC Date

November 4, 2003

Last Update Submit

January 10, 2017

Conditions

Colorectal CancerMetastatic Cancer

Keywords

stage IV colon cancerstage IV rectal cancerliver metastasesrecurrent rectal cancerrecurrent colon cancer

Outcome Measures

Primary Outcomes (2)

  • safety measure

    adverse event reporting

    up to day 57

  • toxicity grading

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

    up to day 57

Secondary Outcomes (1)

  • tumor response compared at four weeks to baseline

    baseline and four weeks

Study Arms (1)

Experimental Group

EXPERIMENTAL

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

Biological: adenovirus vectorBiological: interleukin-12 gene

Interventions

adenovirus vectorBIOLOGICAL
Experimental Group
interleukin-12 geneBIOLOGICAL
Experimental Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasm MetastasisColonic NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Max W. Sung, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 4, 2003

First Posted

November 6, 2003

Study Start

September 1, 2003

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

January 11, 2017

Record last verified: 2017-01

Locations

US(1)