Status:
TERMINATED
Everolimus (RAD001) For Advanced Renal Cell Carcinoma (RCC) Before Kidney Removal
Lead Sponsor:
Linda C. Higgins
Collaborating Sponsors:
University of Texas Southwestern Medical Center
Conditions:
Kidney Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this multicenter, pilot, open-label, Phase II clinical trial is to discover if Everolimus(RAD001) is safe and effective in people who have advanced kidney cancer (renal cell carcinoma -...
Detailed Description
Everolimus has significantly improved outcomes following prior therapy. This study is a biomarker driven Phase II trial that will assess the activity of everolimus as first-line therapy for renal cell...
Eligibility Criteria
Inclusion
- Advanced (metastatic) RCC
- Histology: clear cell, papillary or chromophobe
- 3 out 6 risk factors (by Memorial Sloan Kettering Cancer Center criteria and one additional criterion: multiple sites of metastasis) or not candidates for or refuse sunitinib.
- Must have at least one measurable metastatic site according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria that has not been previously irradiated.
- Must be deemed surgical candidates for cytoreductive nephrectomy by the urologist.
- Age 18 years of age or older
- Eastern Cooperative Oncology Group (EGOG) PS 0-2
- Adequate bone marrow function
- Adequate liver function as shown by:
- Adequate renal function
- Fasting serum cholesterol AND fasting triglycerides within normal limits
- Signed informed consent
Exclusion
- Collecting duct, medullary histologies or sarcomatoid differentiation.
- Central Nervous System (CNS) or leptomeningeal metastases.
- Inappropriate candidates for cytoreductive nephrectomy or who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
- severely impaired lung function
- uncontrolled diabetes
- active (acute or chronic) or uncontrolled severe infections
- liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
- Ineligible for cytoreductive nephrectomy
- Current or prior systemic anticancer therapies (including chemotherapy, antibody based therapy, or investigational drugs)
- Other malignancies within the past 3 years except for localized carcinoma of the cervix, basal or squamous cell carcinomas of the skin, or localized prostate cancer with Gleason Score less than 7 treated with radiation or surgery and no evidence of progression.
- Major surgery (defined as requiring general anesthesia) or significant traumatic injury within 4 weeks of start of enrollment
- Anticipated major surgery (other than CN) during the course of the study
- A known history of HIV seropositivity
- Hepatitis C seropositivity
- Chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
- Immunization with attenuated live vaccines within one week of study entry or during study period
- Known hypersensitivity to RAD001 (everolimus) or other rapamycins or to its excipients
- Impairment of gastrointestinal function or gastrointestinal disease
- Active, bleeding diathesis
- Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
- History of noncompliance to medical regimens
- Unwilling to or unable to comply with the protocol including mandated biopsies
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00831480
Start Date
April 1 2011
End Date
December 1 2014
Last Update
March 21 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
2
Baylor College of Medicine
Houston, Texas, United States, 77030