NCT00096525

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 10, 2004

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

1.1 years

First QC Date

November 9, 2004

Last Update Submit

January 15, 2013

Conditions

Kidney Cancer

Keywords

recurrent renal cell cancerstage III renal cell cancerstage IV renal cell cancer

Outcome Measures

Primary Outcomes (1)

  • Efficacy (complete and partial response)

Secondary Outcomes (2)

  • Toxicity

  • Adverse events

Interventions

lenalidomideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related 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. doi: 10.1007/s10637-007-9107-y. Epub 2007 Dec 27.

    PMID: 18161005RESULT

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

PhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Gnanamba V. Kondagunta, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 9, 2004

First Posted

November 10, 2004

Study Start

July 1, 2004

Primary Completion

August 1, 2005

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

US(1)