Kidney Cancer
Conditions
Keywords
stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer
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.
Interventions
DRUGlenalidomide
drug
Sponsors
The Cleveland Clinic
National Cancer Institute (NCI)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate | Baseline and every 2 weeks until study completion, up to 1.5 years | The objective response rate was defined by RECIST. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity--Most Common AEs | Baseline and every 2 weeks until study completion. Number of cycles is open ended. | Most commonly reported Serious Adverse Events |
| Overall Survival | 1 to 16 cycles, until patient expires, is lost to follow up or withdraws consent | — |
Countries
United States
Contacts
STUDY_CHAIRRobert Dreicer, MD, FACP
Case Comprehensive Cancer Center
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 9.3 |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 11 / 28 |
| other Total, other adverse events | 28 / 28 |
| serious Total, serious adverse events | 16 / 28 |
Outcome results
None listed