Clinical trial · Interventional
Interleukin-12 and Interferon Alfa in Treating Patients With Metastatic Kidney Cancer or Malignant Melanoma
Phase I Trial of rhIL-12 and rHuIFN-a2b in Patients With Metastatic Renal Cell Carcinoma or Malignant Melanoma
NCT00004244CI-TRIAL-00009791completedPhase 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)
This phase I trial is studying the side effects and best dose of interleukin-12 and interferon alfa in treating patients with metastatic kidney cancer or malignant melanoma. 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. Interferon alfa may interfere with the growth of cancer cells. Combining interleukin-12 and interferon alfa may kill more cancer cells.
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 |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Melanoma (Skin) | Melanoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant interferon alfa | Biological | — | UNRESOLVED |
| recombinant interleukin-12 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive interleukin-12 subcutaneously (SC) twice a week and interferon alfa SC three times a week every week for 4 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of interleukin-12 and interferon alfa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities. Patients receive interleukin-12 SC twice a week for 2 weeks, followed by treatment with interleukin-12 in combination with interferon alfa as described above.
- interventionNames
- Biological: recombinant interferon alfa
- Biological: recombinant interleukin-12
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Patients receive interleukin-12 subcutaneously (SC) twice a week and interferon alfa SC three times a week every week for 4 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of interleukin-12 and interferon alfa until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities. Patients receive interferon alfa SC three times a week for 2 weeks, followed by treatment with interleukin-12 in combination with interferon alfa as described above.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed renal cell carcinoma or malignant melanoma * Strong clinical evidence or biopsy proof of metastases to a site or sites distant from the primary tumor * Bidimensionally measurable of evaluable disease * No significant effusions and/or ascites * No more than 3 prior regimens for metastatic disease * No known CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * At least 3 months Hematopoietic: * WBC at least 3,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 9.5 g/dL Hepatic: * Bilirubin no greater than 1.5 mg/dL * ALT/AST no greater than 3 times upper limit of normal Renal: * Creatinine no greater than 1.8 mg/dL * Calcium no greater than 11.5 mg/dL Cardiovascular: * No history of serious cardiac arrhythmia or cardiac arrhythmia requiring treatment * No congestive heart failure * No angina pectoris * No New York Heart Association class III or IV heart disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active peptic ulcer * No autoimmune disease * No inflammatory bowel disease * No local or systemic infections requiring IV antibiotics within the past 28 days * No known seizure disorder * No other prior malignancy except basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or any curatively treated malignancy in complete remission for at least 3 years * HIV, hepatitis B surface antigen, and hepatitis C negative PRIOR CONCURRENT THERAPY: Biologic therapy: * Recovered from prior biologic therapy Chemotherapy: * Recovered from prior chemotherapy Endocrine therapy: * At least 28 days since prior hormonal therapy and recovered * No concurrent corticosteroids except for replacement steroids Radiotherapy: * Recovered from prior radiotherapy * At least 28 days since prior radiotherapy for control of pain from skeletal lesions Surgery: * At least 28 days since prior major surgery requiring general anesthesia * No organ allografts Other: * No concurrent aspirin * No concurrent barbiturates * No other concurrent investigational agents
References
Publications (0)
Data not yet available
No reference posted for this study.