Suspended

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

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What is being tested

adenovirus vector

+ interleukin-12 gene
Biological
Who is being recruted

Colonic Diseases
+8

+ Digestive System Diseases
+ Digestive System Neoplasms
Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: September 2003
See protocol details

Summary

Principal SponsorMax Sung
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 1, 2003Actual date on which the first participant was enrolled.

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.

Official TitlePhase I Trial Of Adenoviral Vector Delivery Of The Human Interleukin-12 cDNA By Intratumoral Injection In Patients With Metastatic Colorectal Cancer To The Liver 
NCT00072098
Principal SponsorMax Sung
Last updated: January 13, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
22 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Colorectal Neoplasms
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene

Study Objectives
Primary Objectives

adverse event reporting

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

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Icahn School of Medicine at Mount SinaiNew York, United StatesSee the location
SuspendedOne Study Center
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