Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer

NCT ID: NCT00096525

Last Updated: 2013-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31

Brief 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.

Detailed 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.

Conditions

Kidney Cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

lenalidomide

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Principal Investigators

Gnanamba V. Kondagunta, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

References

Patel PH, Kondagunta GV, Schwartz L, Ishill N, Bacik J, DeLuca J, Russo P, Motzer RJ. Phase II trial of lenalidomide in patients with metastatic renal cell carcinoma. Invest New Drugs. 2008 Jun;26(3):273-6. doi: 10.1007/s10637-007-9107-y. Epub 2007 Dec 27.

Reference Type: RESULT

PMID: 18161005 (View on PubMed)

Other Identifiers

MSKCC-04014

Identifier Type: -

Identifier Source: secondary_id

04-014

Identifier Type: -

Identifier Source: org_study_id