Clinical trial · Interventional
Biological Therapy in Treating Women With Breast Cancer That Has Spread to the Liver
Phase I Trial of Adenoviral Vector Delivery of the Human Interleukin-12 cDNA by Intratumoral Injection in Patients With Metastatic Breast Cancer to the Liver
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): protocol underwent significant revisions, decision made to terminate study and open as new study listed NCT00849459
Summary
Brief summary (as posted)
RATIONALE: Biological therapy using a gene-modified virus that can make interleukin-12 may help the body build an effective immune response to kill tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of a gene-modified virus that can make interleukin-12 in treating women with breast cancer that has spread to the liver.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adenovirus-mediated human interleukin-12 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- adenovirus-mediated human interleukin-12
- description
- starting dose of ADV-hIL12 - 1 x 10 to the 10th power vp (virus particles) per patient, escalating in half-log increments up to 1 x 10 to the 13th power vp per patient, after which dose escalation will be at lower increments of 2 x 10 to the 13th power vp, to a maximum of 3.0 x 10 to the 13th power vp per patient.
- interventionNames
- Biological: adenovirus-mediated human interleukin-12
Primary outcomes (1)
- measure
- Toxicity
- timeFrame
- up to 15 days
- description
- Serial monitoring of tumor necrosis factor alpha (TNFα) levels
Secondary outcomes (4)
- measure
- Tumor Response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed\* breast adenocarcinoma metastatic to the liver
* Solitary or multiple hepatic metastases
* No malignant involvement of \> 40% of the estimated liver volume NOTE: \*Must be from the hepatic tumor designated for study injection
* Metastatic liver tumors must be measurable in ≥ 2 dimensions on CT scan or MRI
* At least 1 metastatic hepatic tumor ≥ 2 cm in diameter must be visualized by ultrasound and accessible for percutaneous injection under ultrasound guidance
* Extrahepatic metastasis allowed
* No solitary hepatic metastasis eligible for liver resection
* No clinical evidence for severe liver disease (e.g., prior or current ascites or portosystemic encephalopathy)
* Hormone-receptor status not specified
PATIENT CHARACTERISTICS:
* Female
* Menopausal status not specified
* Granulocyte count ≥ 1,500/mm\^3
* Hemoglobin ≥ 9.0 g/dL
* Platelet count ≥ 100,000/mm\^3
* PT ≤ 14.5 sec
* Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 45 mL/min
* Bilirubin ≤ 2 times upper limit of normal (ULN)
* Transaminases ≤ 2.5 times ULN
* Karnofsky performance status ≥ 70%
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for at least 2 months after completion of study treatment
* No active infection or serious intercurrent medical illness
* No HIV infection
* Life expectancy ≥ 16 weeks
* No other malignancy within the past 5 years except inactive nonmelanoma skin cancer, in situ carcinoma of the cervix, or grade 1 papillary bladder cancer
* At highest dose level, patient must weigh ≥ 30 kg
PRIOR CONCURRENT THERAPY:
* No systemic immunosuppressive drugs, including corticosteroids, within 2 months prior to study entry
* Not require immunosuppressive drugs or anticoagulant therapy with heparin or warfarin for at least 2 months after study treatment
* No chemotherapy within 4 weeks of study entry (6 weeks for nitrosoureas)References
Publications (0)
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