Lenalidomide in Treating Patients With Advanced or Unresectable Kidney Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by The Cleveland Clinic.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
The Cleveland Clinic
Collaborator:
Information provided by:
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00403169
First received: November 21, 2006
Last updated: May 12, 2010
Last verified: January 2007
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Cancer |
Drug: lenalidomide |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study of CC-5013 in Patients With Advanced Renal Cell Carcinoma (RCC) |
Resource links provided by NLM:
Further study details as provided by The Cleveland Clinic:
Primary Outcome Measures:
- Overall response [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Toxicity [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 26 |
| Study Start Date: | August 2004 |
OBJECTIVES:
- Evaluate the best response in patients with advanced or unresectable renal cell carcinoma (RCC) treated with lenalidomide.
- Evaluate the response duration, time to tumor progression, and survival of patients with advanced RCC treated with lenalidomide.
- Evaluate the safety of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive oral lenalidomide daily on days 1-21. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
After completion of study treatment, patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 26 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 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00403169
Locations
| United States, Ohio | |
| Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44106-5065 | |
Sponsors and Collaborators
The Cleveland Clinic
Investigators
| Study Chair: | Robert Dreicer, MD, FACP | Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00403169 History of Changes |
| Other Study ID Numbers: | CASE-CCF-7165, P30CA043703, CASE-CCF-7165 |
| Study First Received: | November 21, 2006 |
| Last Updated: | May 12, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by The Cleveland Clinic:
|
stage III renal cell cancer stage IV renal cell cancer recurrent 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 19, 2013