search
Back to results

Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer

Primary Purpose

Kidney Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
lenalidomide
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring recurrent renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Memorial Sloan-Kettering Cancer Center

Outcomes

Primary Outcome Measures

Efficacy (complete and partial response)

Secondary Outcome Measures

Toxicity
Adverse events

Full Information

First Posted
November 9, 2004
Last Updated
January 15, 2013
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00096525
Brief Title
Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
recurrent renal cell cancer, stage III renal cell cancer, stage IV renal cell cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
lenalidomide
Primary Outcome Measure Information:
Title
Efficacy (complete and partial response)
Secondary Outcome Measure Information:
Title
Toxicity
Title
Adverse events

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gnanamba V. Kondagunta, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan-Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18161005
Citation
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.
Results Reference
result

Learn more about this trial

Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer

We'll reach out to this number within 24 hrs