Clinical trial · Interventional
PEG-Interferon Alfa-2b in Treating Patients With Metastatic Kidney Cancer
Phase II Trial of PEG-Intron in Patients With Advanced Renal Cell Carcinoma
NCT00045279CI-TRIAL-00010590completedPhase 2ClinicalTrials.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: PEG-interferon alfa-2b may stop the growth of kidney cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have metastatic kidney cancer.
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 |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEG-interferon alfa-2b | Biological | Peginterferon Alfa-2b | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma * Metastatic disease * No prior therapy for advanced disease * Tumor sample available for molecular analysis with prior registration on MSKCC IRB # 89-076 * Bidimensionally measurable disease * No brain metastases unless completely resected and without evidence of recurrence for at least six months PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * WBC at least 3,000/mm3 * Platelet count at least 100,000/mm3 Hepatic * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 2.5 times upper limit of normal (unless due to hepatic metastases) * Hepatitis B surface antigen negative * Hepatitis C negative Renal * Creatinine no greater than 2 mg/dL Cardiovascular * No severe cardiac disease * No New York Heart Association class III or IV cardiac disease * No myocardial infarction within the past 12 months * No ventricular tachyarrhythmias requiring ongoing treatment * No unstable angina Pulmonary * No severe asthma requiring chronic systemic steroids Other * HIV negative * Negative pregnancy test * Fertile patients must use effective contraception * No malignancy within the past 2 years except basal cell or squamous cell skin cancer, superficial bladder cancer, or localized prostate cancer * Patients who have undergone potentially curative therapy and have been deemed to be at low risk for recurrence are eligible * No medically significant psychiatric disease (e.g., endogenous depression, psychosis, or bipolar disease) requiring hospitalization * No prior or active autoimmune disease * Medically controlled diabetes or thyroid dysfunction allowed * No clinically significant acute viral or bacterial infection that requires specific therapy PRIOR CONCURRENT THERAPY: Biologic therapy * No prior interleukin-2 * No prior interferon alfa * No concurrent cytokines or biological response modifiers except epoetin alfa in the case of hematologic compromise * No concurrent tumor vaccines * No concurrent monoclonal antibodies * No concurrent bone marrow/stem cell transplantation Chemotherapy * No concurrent cytotoxic agents Endocrine therapy * No concurrent high-dose systemic steroids * Concurrent low-dose corticosteroids (e.g., asthma inhalers, topical creams, or intra-articular injections) allowed * No concurrent hormonal therapy (including megestrol) * Concurrent hormone replacement therapy or oral contraceptives allowed Radiotherapy * At least 4 weeks since prior radiotherapy * No concurrent radiotherapy Surgery * See Disease Characteristics * At least 4 weeks since prior major surgery * Concurrent nephrectomy allowed Other * At least 14 days since prior anti-infectious therapy * No other concurrent investigational drugs
References
Publications (2)
- RESULTFeldman DR, Kondagunta GV, Schwartz L, Patil S, Ishill N, DeLuca J, Russo P, Motzer RJ. Phase II trial of pegylated interferon-alpha 2b in patients with advanced renal cell carcinoma. Clin Genitourin Cancer. 2008 Mar;6(1):25-30. doi: 10.3816/cgc.2008.n.004. PMID 18501079
- RESULTMotzer RJ, Rakhit A, Thompson J, Gurney H, Selby P, Figlin R, Negrier S, Ernst S, Siebels M, Ginsberg M, Rittweger K, Hooftman L. Phase II trial of branched peginterferon-alpha 2a (40 kDa) for patients with advanced renal cell carcinoma. Ann Oncol. 2002 Nov;13(11):1799-805. doi: 10.1093/annonc/mdf288. PMID 12419754