Clinical trial NCT00403169: Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
Official title: Phase II Study of CC-5013 in Patients With Advanced Renal Cell Carcinoma (RCC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Kidney Cancer
Keywords: stage III renal cell cancer
stage IV renal cell cancer
recurrent renal cell cancer
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-11-23
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: RATIONALE: Lenalidomide may stop the growth of kidney cancer by blocking 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.

Detailed description: OBJECTIVES:

* Evaluate the best response in patients with advanced or unresectable renal cell carcinoma (RCC) treated with lenalidomide.
* Evaluate the response duration, time to tumor progression, and survival of patients with advanced RCC treated with lenalidomide.
* Evaluate the safety of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive oral lenalidomide daily on days 1-21. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed renal cell carcinoma (RCC)

  * Advanced or unresectable RCC
* Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques OR ≥ 10 mm with spiral CT scan
* No brain metastases

  * Brain metastases that have been treated with either radiotherapy or surgery and remain asymptomatic, with no active brain metastases, as shown by CT scan or MRI, for ≥ 6 months are allowed

PATIENT CHARACTERISTICS:

* ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Creatinine ≤ 2.0 mg/dL
* Bilirubin ≤ 1.5 mg/dL
* AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if hepatic metastases are present)
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other malignancies within the past 5 years, except for treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, localized prostate cancer, or superficial bladder cancer
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to lenalidomide or thalidomide
* No uncontrolled intercurrent illness including, but not limited to, any of the following:

  * Ongoing or active infection
  * Symptomatic congestive heart failure
  * Unstable angina pectoris
  * Cardiac arrhythmia
  * Psychiatric illness or social situation that would limit study compliance
* No hepatitis A, B, or C positivity
* No HIV positivity

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No more than 1 prior systemic therapy for RCC (e.g., chemotherapy, hormonal therapy, immunotherapy)
* At least 4 weeks since prior surgery, radiotherapy, hormonal therapy, chemotherapy, or immunotherapy and recovered
* No prior lenalidomide
* No other concurrent anticancer agents or treatments
* No other concurrent investigational agents
* No concurrent sargramostim (GM-CSF), radiotherapy, or thalidomide

Primary outcomes:
measure: Overall response
Secondary outcomes:
measure: Toxicity
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Robert Dreicer, MD, FACP
role: STUDY_CHAIR
References: