Clinical trial · Interventional
Interferon Alfa With or Without Thalidomide in Treating Patients With Metastatic Kidney Cancer
Interferon Alpha In Combination With Thalidomide In The Treatment Of Metastatic Renal Cell Carcinoma A Randomized Phase II Study
- 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: Interferon alfa may interfere with the growth of cancer cells. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known if interferon alfa is more effective with or without thalidomide in treating metastatic kidney cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of interferon alfa with or without thalidomide 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| recombinant interferon alfa | Biological | — | UNRESOLVED |
| thalidomide | Drug | Thalidomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Safety
- measure
- Toxicity
- measure
- Response rate
- measure
- Anti-angiogenic effect
- measure
- Quality of life
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic renal cell carcinoma * Measurable progressive disease, defined as non-irradiated marker lesions greater than 1 cm PATIENT CHARACTERISTICS: Age: * Over 18 Performance status: * WHO 0-2 Life expectancy: * More than 12 weeks Hematopoietic: * Neutrophil count greater than 1,500/mm\^3 * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 10 g/dL Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * AST/ALT less than 5 times ULN Renal: * Creatinine clearance greater than 50 mL/min OR * Edetic acid clearance greater than 40 mL/min Cardiovascular: * No unstable angina or myocardial infarction within the past 6 months Other: * No other prior invasive malignancy except cervical intraepithelial neoplasia or nonmelanomatous skin cancer * No chronic neurological disease causing peripheral neuropathy * No diabetes mellitus * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use at least one highly effective method and at least one additional effective method of contraception for female patients and barrier contraception for male patients for at least 2 weeks before and during study PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior interferon alfa for metastatic renal cell carcinoma Chemotherapy: * No prior systemic chemotherapy for metastatic renal cell carcinoma * No concurrent cytotoxic therapy Endocrine therapy: * No concurrent corticosteroids Radiotherapy: * See Disease Characteristics * Concurrent local radiotherapy for symptomatic secondary sites of disease allowed if these sites are not being used as markers of disease response Surgery: * Not specified Other: * No other prior systemic treatment for metastatic renal cell carcinoma * No concurrent chronic medication known to cause peripheral neuropathy
References
Publications (0)
Data not yet available