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Phase II Study of CC-5013 in Patients With Advanced Renal Cell Carcinoma (RCC)

Phase 2
18 Years
Open (Enrolling)
Kidney Cancer

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Trial Information

Phase II Study of CC-5013 in Patients With Advanced Renal Cell Carcinoma (RCC)


- 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.

Inclusion Criteria


- 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


- 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

- 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


- See Disease Characteristics

- No more than 1 prior systemic therapy for RCC (e.g., chemotherapy, hormonal therapy,

- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response

Safety Issue:


Principal Investigator

Robert Dreicer, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2004

Completion Date:

Related Keywords:

  • Kidney Cancer
  • stage III renal cell cancer
  • stage IV renal cell cancer
  • recurrent renal cell cancer
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065