Clinical trial · Interventional
PEG-Interferon Alfa-2b and Sorafenib in Treating Patients With Unresectable or Metastatic Kidney Cancer
A Phase I Study Of Peginterferon Alfa-2b (PEG-INTRON) With Sorafenib (Nexavar) In Patients With Unresectable Or Metastatic Clear Cell Renal Carcinoma (RCC).
NCT00589550CI-TRIAL-00018205terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of kidney cancer by blocking blood flow to the tumor. Giving PEG-interferon alfa-2b together with sorafenib may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon alfa-2b and sorafenib in treating patients with 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 (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| flow cytometry | Other | — | UNRESOLVED |
| gene expression analysis | Genetic | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| PEG-interferon alfa-2b | Biological | Peginterferon Alfa-2b | ALIAS |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
| reverse transcriptase-polymerase chain reaction | Genetic | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Peginterferon alfa-2b
- description
- Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.
- interventionNames
- Biological: PEG-interferon alfa-2b
- Drug: Sorafenib
- Genetic: gene expression analysis
- Genetic: polymerase chain reaction
- Genetic: reverse transcriptase-polymerase chain reaction
- Other: flow cytometry
- Other: immunoenzyme technique
- Other: laboratory biomarker analysis
Primary outcomes (2)
- measure
- Maximum Tolerated Dose of PEG-interferon Alfa-2b and Sorafenib Tosylate
- timeFrame
- up to 2 months
- measure
- Characterize the Toxicity of Peginterferon Alfa-2b and Sorafenib in Patients With Metastatic or Unresectable Clear Cell Renal Cell Carcinoma.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have histologically or cytologically confirmed clear cell renal cell carcinoma (RCC) * Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension and is ≥ 1.0 cm by spiral CT scan * No prior treatment except PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy \> 6 months * Good/intermediate Motzer prognostic status * ANC ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 10.0 g/dL * Total bilirubin ≤ 2.0 mg/dL * AST and ALT \< 2.5 times normal * Creatinine ≤ 1.8 mg/dL OR creatinine clearance \> 50 mL/min * Calcium \< 12 mg/dL (when corrected for serum albumin) * INR \< 1.5 times upper limit of normal * Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40% by 2D echo * Pulse oximetry ≥ 90% at rest on room air * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception * No evidence of bleeding diathesis * No uncontrolled coagulation disorders * No active infections requiring IV antibiotics * No known HIV, hepatitis C, or hepatitis B * No autoimmune disease requiring ongoing therapy * No requirement for adrenal replacement * No angina (controlled or uncontrolled) * No uncontrolled hypertension * No history of other major medical illnesses including, but not limited to, any of the following: * Cardiac ischemia * Myocardial infarction * Major cardiac arrhythmias * Inflammatory bowel disorders * No other prior malignancy except for previously treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 3 years * No significant psychiatric disease that, in the opinion of the principal investigator, would preclude giving adequate informed consent or render immunotherapy unsafe PRIOR CONCURRENT THERAPY: * No prior treatment for RCC except sunitinib malate * Patients may have progressed or have been intolerant to sunitinib malate * No prior systemic treatment for metastatic disease (other than sunitinib malate) * No prior organ allografts * At least 2 weeks since prior laparoscopic/robotic surgery * At least 4 weeks since prior open nephrectomy * More than 4 weeks since prior and no concurrent radiotherapy or other surgery * More than 4 weeks since prior systemic steroids * More than 2 weeks since prior topical, injected, or inhaled steroids * No concurrent steroid therapy * No concurrent Hypericum perforatum (St. John's wort)
References
Publications (0)
Data not yet available
No reference posted for this study.