Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

Phase II Trial of CC-5013 in Patients With Advanced Renal Cell Carcinoma With Either No Prior Treatment or One Prior Treatment Regimen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00096525
• Other study ID #: 04-014
• Secondary ID: MSKCC-04014
• Status: Completed
• Phase: Phase 2
• First received: November 9, 2004
• Last updated: January 15, 2013
• Start date: July 2004

Study information

• Verified date: January 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• lenalidomide

Locations

Country	Name	City	State
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Epub 2007 Dec 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy (complete and partial response)			No
Secondary	Toxicity			Yes
Secondary	Adverse events			Yes