Kidney Cancer Clinical Trial

Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer

Summary

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.

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Full Description

OBJECTIVES:

Primary

Determine the best response in patients with advanced or unresectable renal cell cancer treated with lenalidomide (CC-5013).
Determine the time to disease progression in patients treated with this drug.

Secondary

Determine the safety of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive oral lenalidomide (CC-5013) once daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 30 days and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Study ID:

NCT00096525

Recruitment Status:

Completed

Sponsor:

Memorial Sloan Kettering Cancer Center

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There is 1 Location for this study

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Memorial Sloan-Kettering Cancer Center
New York New York, 10021, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Study ID:

NCT00096525

Recruitment Status:

Completed

Sponsor:


Memorial Sloan Kettering Cancer Center

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