Clinical trial · Interventional
Interferon Alfa-2b With or Without Bevacizumab in Treating Patients With Advanced Renal Cell Carcinoma (Kidney Cancer)
A Randomized Phase III Trial Of Interferon Alfa-2B Or Interferon Alfa-2B Plus Bevacizumab In Patients With Advanced Renal Carcinoma
- 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: Biological therapies, such as interferon alfa-2b, may interfere with the growth of tumor cells. Bevacizumab may stop the growth of tumor cells by stopping blood flow to the tumor. It is not yet known whether interferon alfa-2b is more effective with or without bevacizumab in treating advanced renal cell carcinoma (kidney cancer). PURPOSE: This randomized phase III trial is studying interferon alfa-2b and bevacizumab to see how well they work compared to interferon alfa-2b alone in treating patients with advanced renal cell carcinoma.
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 |
|---|---|---|---|
| bevacizumab | Biological | Bevacizumab | ALIAS |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interferon
- description
- Treatment with interferon alfa 2b
- interventionNames
- Biological: recombinant interferon alfa
- type
- EXPERIMENTAL
- label
- Interferon + bevacizumab
- description
- Addition of bevacizumab to interferon alfa 2b treatment
- interventionNames
- Biological: bevacizumab
- Biological: recombinant interferon alfa
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically or cytologically confirmed renal cell carcinoma (RCC)
* Conventional clear cell carcinoma
* Metastatic or unresectable disease
* The following characteristics and cellular types are excluded:
* True papillary
* Sarcomatoid features without a clear cell component
* Chromophobe
* Oncocytoma
* Collecting duct tumor
* Transitional cell carcinoma
* Measurable or nonmeasurable disease, including any of the following:
* Unidimensionally measurable lesion ≥ 20 mm by conventional techniques (e.g., physical exam or chest x-ray) OR 10 mm by spiral CT scan or MRI
* The following are considered nonmeasurable disease:
* Small lesions
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Lymphangitis cutis/pulmonis
* Abdominal masses that are not confirmed and followed by imaging techniques
* Cystic lesions
* Irradiated lesions, unless progression is documented after radiotherapy
* RCC paraffin tissue blocks or unstained slides must be available
* No evidence of prior or concurrent CNS metastases by MRI or CT scan
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Karnofsky 70-100%
Life expectancy
* Not specified
Hematopoietic
* Granulocyte count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* No history of clinically significant bleeding
Hepatic
* AST/ALT ≤ 2.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 2.5 times ULN
* Bilirubin ≤ 1.5 times ULN
Renal
* Creatinine ≤ 1.5 times ULN
* No proteinuria \> 1+
* Proteinuria ≥ 2+ allowed provided protein is \< 2 g/24-hour urine collection
Cardiovascular
* No deep venous thrombosis within the past year
* No cerebrovascular accident within the past year
* No peripheral vascular disease with claudication on \< 1 block
* No uncontrolled hypertension defined as blood pressure ≥160 mm Hg (systolic) and/or ≥ 90 mm Hg (diastolic) while on medication
* No New York Heart Association class II-IV congestive heart failure
* No angina pectoris requiring nitrate therapy
* No myocardial infarction within the past 6 months
* No other significant cardiovascular disease
Pulmonary
* No pulmonary embolus within the past year
* No ongoing hemoptysis
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study treatment
* No preexisting thyroid abnormality in which normal thyroid function cannot be maintained by medication
* No delayed wound healing, ulcers, or bone fractures
* No uncontrolled psychiatric disorder
* No other currently active\* malignancy except nonmelanoma skin cancer NOTE: \*Disease is not considered currently active if patient completed anticancer therapy and is considered to have \< 30% risk of relapse
PRIOR CONCURRENT THERAPY:
Biologic therapy
* No prior systemic immunotherapy for RCC
* No prior thalidomide, anti-vascular endothelial growth factor (VEGF) therapy, VEGF receptor inhibitors, or antiangiogenic treatment of any kind
* No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)
Chemotherapy
* No prior systemic chemotherapy for RCC
* No concurrent chemotherapy
Endocrine therapy
* No concurrent systemic corticosteroid therapy except the following:
* Topical and inhaled steroids
* Replacement therapy for adrenal insufficiency
* No concurrent hormones except those administered for nondisease-related conditions (e.g., insulin for diabetes)
Radiotherapy
* See Disease Characteristics
* At least 4 weeks since prior radiotherapy and recovered
* Prior palliative radiotherapy to metastatic lesions allowed provided at least 1 measurable or nonmeasurable lesion remains untreated
* No concurrent palliative radiotherapy
Surgery
* At least 4 weeks since prior major surgery and recovered
Other
* No other prior systemic investigational therapy for RCC
* No other prior adjuvant or neoadjuvant systemic therapy for RCC
* No concurrent full-dose oral or parenteral anticoagulation\* NOTE: \*Low-dose (1 mg) warfarin for maintenance of catheter patency and/or daily prophylactic aspirin is allowedReferences
Publications (7)
- RESULTRini BI, Halabi S, Rosenberg JE, Stadler WM, Vaena DA, Archer L, Atkins JN, Picus J, Czaykowski P, Dutcher J, Small EJ. Phase III trial of bevacizumab plus interferon alfa versus interferon alfa monotherapy in patients with metastatic renal cell carcinoma: final results of CALGB 90206. J Clin Oncol. 2010 May 1;28(13):2137-43. doi: 10.1200/JCO.2009.26.5561. Epub 2010 Apr 5. PMID 20368558
- RESULTRini BI, Halabi S, Rosenberg J, et al.: Bevacizumab plus interferon-alpha versus interferon-alpha monotherapy in patients with metastatic renal cell carcinoma: results of overall survival for CALGB 90206. [Abstract] J Clin Oncol 27 (Suppl 15): A-LBA5019, 2009.
- RESULTRini BI, Halabi S, Rosenberg JE, et al.: CALGB 90206: a phase III trial of bevacizumab plus interferon-alpha versus interferon-alpha monotherapy in metastatic renal cell carcinoma. [Abstract] American Society of Clinical Oncology 2008 Genitourinary Cancers Symposium, Feb 14-16, 2008, San Francisco, CA. A-350, 2008.
- RESULTRini BI, Halabi S, Rosenberg JE, Stadler WM, Vaena DA, Ou SS, Archer L, Atkins JN, Picus J, Czaykowski P, Dutcher J, Small EJ. Bevacizumab plus interferon alfa compared with interferon alfa monotherapy in patients with metastatic renal cell carcinoma: CALGB 90206. J Clin Oncol. 2008 Nov 20;26(33):5422-8. doi: 10.1200/JCO.2008.16.9847. Epub 2008 Oct 20. PMID 18936475
- RESULTRini BI, Halabi S, Taylor J, Small EJ, Schilsky RL; Cancer and Leukemia Group B. Cancer and Leukemia Group B 90206: A randomized phase III trial of interferon-alpha or interferon-alpha plus anti-vascular endothelial growth factor antibody (bevacizumab) in metastatic renal cell carcinoma. Clin Cancer Res. 2004 Apr 15;10(8):2584-6. doi: 10.1158/1078-0432.ccr-03-0605. PMID 15102658
- DERIVEDAldin A, Besiroglu B, Adams A, Monsef I, Piechotta V, Tomlinson E, Hornbach C, Dressen N, Goldkuhle M, Maisch P, Dahm P, Heidenreich A, Skoetz N. First-line therapy for adults with advanced renal cell carcinoma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 May 4;5(5):CD013798. doi: 10.1002/14651858.CD013798.pub2.