Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer

NeuroTherapia, Inc.

Status and phase

Completed

Phase 2

Conditions

Kidney Cancer

Treatments

Drug: lenalidomide

Study type

Interventional

Funder types

Other

NIH

Identifiers

P30CA043703 (U.S. NIH Grant/Contract)

CASE-CCF-7165

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 estimated patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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