Clinical trial · Interventional
Interleukin-12 in Treating Patients With Advanced Cancer
Phase I Clinical Trials of IV rhIL-12 With or Without a Test-Dose in Patients With Advanced Malignancies (rhIL-12 NSC# 672423)
NCT00003330CI-TRIAL-00009412completedPhase 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)
Phase I trial to study the effectiveness of interleukin-12 in treating patients who have advanced cancer. Interleukin-12 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill cancer cells.
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 |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant interleukin-12 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- See detailed description.
- interventionNames
- Biological: recombinant interleukin-12
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective * Advanced measurable or evaluable disease that is clearly progressive * No brain metastases PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: ECOG 0-1 Karnofsky 80-100% * Life expectancy: At least 3 months * WBC greater than 4,000/mm3 * Platelet count greater than 100,000/mm3 * Bilirubin less than 1.5 mg/dL * SGOT/SGPT less than 2 times normal * Creatinine less than 1.5 mg/dL * Creatinine clearance at least 60 mL/min * No congestive heart failure * No coronary artery disease * No serious cardiac arrhythmias * No evidence of prior myocardial infarction on EKG * Not pregnant or nursing * Fertile patients must use effective contraception * Not HIV positive * No seizure disorders * No active infection that requires antibiotic therapy * No significant medical disease other than the malignancy PRIOR CONCURRENT THERAPY: * No more than 2 prior biological response modifier treatment regimen * No immunotherapy within the past 4 weeks * No prior interleukin-12 * No more than 2 prior chemotherapy regimens * At least 4 weeks since chemotherapy and recovered * At least 6 weeks since nitrosoureas or mitomycin and recovered * No concurrent chemotherapy * At least 4 weeks since hormone therapy and recovered * No concurrent hormone therapy * No concurrent corticosteroids * At least 4 weeks since radiotherapy and recovered * No concurrent radiotherapy * No organ allografts * At least 2 weeks since intravenous antibiotics
References
Publications (2)
- RESULTGollob JA, Mier JW, Veenstra K, McDermott DF, Clancy D, Clancy M, Atkins MB. Phase I trial of twice-weekly intravenous interleukin 12 in patients with metastatic renal cell cancer or malignant melanoma: ability to maintain IFN-gamma induction is associated with clinical response. Clin Cancer Res. 2000 May;6(5):1678-92. PMID 10815886
- RESULTGollob JA, Veenstra KG, Mier JW, Atkins MB. Agranulocytosis and hemolytic anemia in patients with renal cell cancer treated with interleukin-12. J Immunother. 2001 Jan-Feb;24(1):91-8. doi: 10.1097/00002371-200101000-00011. PMID 11211153