Clinical trial · Interventional
Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
Phase II Trial of CC-5013 in Patients With Advanced Renal Cell Carcinoma With Either No Prior Treatment or One Prior Treatment Regimen
NCT00096525CI-TRIAL-00008974completedPhase 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: Biological therapy such as lenalidomide use different ways to stimulate the immune system and stop tumor cells from growing. It may also stop the growth of tumor cells by stopping blood flow to the tumor. PURPOSE: This phase II trial is studying how well lenalidomide works in treating patients with advanced or unresectable 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 |
|---|---|---|---|
| lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Efficacy (complete and partial response)
Secondary outcomes (2)
- measure
- Toxicity
- measure
- Adverse events
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma (RCC) * Advanced or unresectable disease * At least 1 measurable lesion * No active brain metastases * Prior brain metastases allowed provided patient has been treated with radiotherapy or surgery AND remains asymptomatic for ≥ 6 months PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Karnofsky 70-100% Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 mg/dL * AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) * No hepatitis A, B, or C infection Renal * Creatinine ≤ 2.0 mg/dL Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No known hypersensitivity to thalidomide * No other serious medical condition, laboratory abnormality, or psychiatric illness that would preclude giving informed consent * No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or breast, localized prostate cancer, or superficial bladder cancer PRIOR CONCURRENT THERAPY: Biologic therapy * No more than 1 prior systemic immunotherapy regimen for RCC * No prior lenalidomide (CC-5013) * No prior or concurrent thalidomide Chemotherapy * No more than 1 prior systemic chemotherapy regimen for RCC Endocrine therapy * No more than 1 prior systemic hormonal therapy regimen for RCC Radiotherapy * See Disease Characteristics * No concurrent radiotherapy Surgery * See Disease Characteristics * At least 4 weeks since prior surgery and recovered Other * No more than 1 other prior systemic therapy regimen for RCC * No other concurrent anticancer therapies * No other concurrent investigational agents
References
Publications (1)
- RESULTPatel PH, Kondagunta GV, Schwartz L, Ishill N, Bacik J, DeLuca J, Russo P, Motzer RJ. Phase II trial of lenalidomide in patients with metastatic renal cell carcinoma. Invest New Drugs. 2008 Jun;26(3):273-6. doi: 10.1007/s10637-007-9107-y. Epub 2007 Dec 27. PMID 18161005