NCT00403169

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2004

Longer than P75 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

April 20, 2017

Status Verified

April 1, 2017

Enrollment Period

4.8 years

First QC Date

November 21, 2006

Last Update Submit

April 18, 2017

Conditions

Kidney Cancer

Keywords

stage III renal cell cancerstage IV renal cell cancerrecurrent renal cell cancer

Outcome Measures

Primary Outcomes (1)

  • Overall response

Secondary Outcomes (1)

  • Toxicity

Study Arms (1)

Lenalidomide for Advanced RCC

EXPERIMENTAL

25 mg/day Lenalidomide for 21 days per cycle.

Drug: lenalidomide

Interventions

lenalidomideDRUG

drug

Also known as: CC-5013
Lenalidomide for Advanced RCC

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

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

Sponsors & Collaborators

Study Sites (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

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

  • Robert Dreicer, MD, FACP

    Case Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2006

First Posted

November 23, 2006

Study Start

August 1, 2004

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

April 20, 2017

Record last verified: 2017-04

Locations

US(1)