Clinical trial · Interventional
SU5416 and Interferon Alfa-2b in Treating Patients With Unresectable or Metastatic Kidney Cancer
Phase II Trial of SU5416 and Interferon Alfa 2B in Unresectable or Metastatic Renal Cell Carcinoma
NCT00006384CI-TRIAL-00005665completedPhase 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: SU5416 may stop the growth of kidney cancer by stopping blood flow to the tumor. Interferon alfa-2b may interfere with the growth of the cancer cells. Combining interferon alfa-2b with SU5416 may be an effective treatment for kidney cancer. PURPOSE: Phase II trial to study the effectiveness of combining SU5416 and interferon alfa-2b in treating patients who have unresectable or 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant interferon alfa | Biological | — | UNRESOLVED |
| semaxanib | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically confirmed unresectable or metastatic renal cell carcinoma Measurable or evaluable disease Prior nephrectomy allowed if documented disease progression prior to study No known brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500/mm3 Absolute granulocyte count at least 1,500/mm3 Platelet count at least lower limit of normal Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No uncompensated coronary artery disease by ECG or physical examination No myocardial infarction or severe/unstable angina within the past 6 months No severe peripheral vascular disease associated with diabetes mellitus No deep venous or arterial thrombosis within the past 3 months Pulmonary: No pulmonary embolism within the past 3 months Other: No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception No documented hypersensitivity to any excipients (Cremophor EL, ethanol, or polyethylene glycol) of SU5416 PRIOR CONCURRENT THERAPY: Biologic therapy: At least 8 weeks since prior interleukin-2 and recovered No other prior biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy and recovered No more than 1 prior chemotherapy regimen Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy No concurrent radiotherapy to measurable lesions Surgery: See Disease Characteristics More than 3 weeks since prior major surgery
References
Publications (1)
- RESULTLara PN Jr, Quinn DI, Margolin K, Meyers FJ, Longmate J, Frankel P, Mack PC, Turrell C, Valk P, Rao J, Buckley P, Wun T, Gosselin R, Galvin I, Gumerlock PH, Lenz HJ, Doroshow JH, Gandara DR; California Cancer Consortium. SU5416 plus interferon alpha in advanced renal cell carcinoma: a phase II California Cancer Consortium Study with biological and imaging correlates of angiogenesis inhibition. Clin Cancer Res. 2003 Oct 15;9(13):4772-81. PMID 14581348