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Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
This study has been completed.
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00096525
  Purpose

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.


Condition Intervention Phase
Kidney Cancer
Drug: lenalidomide
Phase II

MedlinePlus related topics: Cancer Kidney Cancer
Drug Information available for: Lenalidomide CC 5013
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Efficacy (complete and partial response) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Adverse events [ Designated as safety issue: Yes ]

Study Start Date: July 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00096525

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Gnanamba V. Kondagunta, MD Memorial Sloan-Kettering Cancer Center
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000393197, MSKCC-04014
Study First Received: November 9, 2004
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00096525  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer

Study placed in the following topic categories:
Lenalidomide
Urogenital Neoplasms
Renal cancer
Urologic Neoplasms
Kidney cancer
Recurrence
Carcinoma
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Kidney Diseases
Adenocarcinoma
Urinary tract neoplasm
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009