Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

Phase II Study of CC-5013 in Patients With Advanced Renal Cell Carcinoma (RCC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00403169
• Other study ID #: CASE-CCF-7165
• Secondary ID: P30CA043703CASE-
• Status: Completed
• Phase: Phase 2
• First received: November 21, 2006
• Last updated: April 18, 2017
• Start date: August 2004
• Est. completion date: May 2009

Study information

• Verified date: April 2017
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• lenalidomide
drug

Locations

Country	Name	City	State
United States	Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
The Cleveland Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response
Secondary	Toxicity