Clinical trial · Interventional
Interleukin-12 Gene in Treating Patients With Liver Metastases Secondary to Colorectal Cancer
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
NCT00072098CI-TRIAL-00025457terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): limited funding
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adenovirus vector | Biological | — | UNRESOLVED |
| interleukin-12 gene | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental Group
- description
- Direct intratumoral injection of metastatic hepatic tumors using an adenoviral vector expressing the human recombinant interleukin-12 gene
- interventionNames
- Biological: adenovirus vector
- Biological: interleukin-12 gene
Primary outcomes (2)
- measure
- safety measure
- timeFrame
- up to day 57
- description
- adverse event reporting
- measure
- toxicity grading
- timeFrame
- up to day 57
- description
- toxicity will assessed from grades 0 to 4 as per common toxicity criteria
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 warfarinReferences
Publications (0)
Data not yet available
No reference posted for this study.