Clinical trial · Interventional
Interleukin-12 Gene Therapy in Treating Patients With Skin Metastases
Treament of Spontaneous Tumor Metastases With IL-12 DNA (NSC #709933): A Phase IB Trial
NCT00028652CI-TRIAL-00042274terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Inserting the gene for interleukin-12 into a person's skin tumor cells may make the body build an immune response to kill tumor cells. PURPOSE: Phase I trial to study the effectiveness of interleukin-12 gene therapy in treating patients who have skin metastases.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| interleukin-12 gene | Biological | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed solid malignancy * Surgically or medically incurable disease * No standard chemotherapy or radiotherapy exists for this disease * Tumor of at least 0.5 cm but no more than 2.5 cm infiltrating into or underlying the skin * Cutaneous metastases, subcutaneous metastases, or tumor-involved lymph nodes that are easily palpable PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * More than 3 months Hematopoietic: * WBC greater than 3,000/mm\^3 * Platelet count greater than 80,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL Renal: * Creatinine less than 2.0 mg/dL Other: * HIV negative * No active infections requiring antibiotic, antiviral, or antifungal treatment * No other active malignancy * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 month since prior immunotherapy * No concurrent colony-stimulating factors Chemotherapy: * See Disease Characteristics * At least 1 month since prior chemotherapy Endocrine therapy: * At least 1 month since prior steroids (other than intermittent use as an antiemetic or topical agent) * No concurrent steroids Radiotherapy: * See Disease Characteristics * Prior radiotherapy to vaccine site allowed provided there is documentation of progressive disease Surgery: * See Disease Characteristics * No prior organ allografts Other: * No other concurrent antineoplastic therapy * No other concurrent investigational drugs
References
Publications (0)
Data not yet available
No reference posted for this study.