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Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00096525
First received: November 9, 2004
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  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 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

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
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
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
National Cancer Institute (NCI)
Investigators
Principal Investigator: Gnanamba V. Kondagunta, MD Memorial Sloan-Kettering Cancer Center
  More Information

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

Publications:

ClinicalTrials.gov Identifier: NCT00096525     History of Changes
Other Study ID Numbers: 04-014, MSKCC-04014
Study First Received: November 9, 2004
Last Updated: January 15, 2013
Health Authority: United States: Federal Government

Keywords provided by Memorial Sloan-Kettering Cancer Center:
recurrent renal cell cancer
stage III renal cell cancer
stage IV renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
 Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Lenalidomide
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013