Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer
NCT ID: NCT00072098
Last Updated: 2017-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1
22 participants
INTERVENTIONAL
2003-09-30
2012-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Interleukin-12 in Treating Patients With Cancer in the Abdomen
NCT00003046
Gene Therapy in Treating Women With Metastatic Breast Cancer
NCT00849459
Interleukin-12 in Treating Patients With Metastatic or Recurrent Breast Cancer
NCT00004893
Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer
NCT00019591
Interleukin-12 in Treating Patients With Advanced Cancer
NCT00003330
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental Group
Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene
adenovirus vector
interleukin-12 gene
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
adenovirus vector
interleukin-12 gene
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Max Sung
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Max Sung
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Max W. Sung, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MTS-GCO-975642
Identifier Type: -
Identifier Source: secondary_id
MTS-GCO-971592
Identifier Type: -
Identifier Source: secondary_id
CDR0000335463
Identifier Type: -
Identifier Source: secondary_id
NIH 9911-359
Identifier Type: -
Identifier Source: secondary_id
GCO 97-0564
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.