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Safety Study of RAD001 to Treat Patients With Metastatic Kidney Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety Study of RAD001 to Treat Patients With Metastatic Kidney Cancer

Phase II Study of RAD001 (Everolimus) in Patient's With Metastatic Renal Cell Cancer

NCT00446368•The Methodist Hospital Research Institute

Summary

Patients with metastatic renal cell cancer will be enrolled to receive RAD001 to determine whether the use of RAD001 will result in an improvement in the time to tumor progression.

Detailed Description

Patients with metastatic renal cell cancer will be enrolled in the study if all eligibility criteria are met and they agree to participate. The participant will take RAD001 (Everolimus) 10mg by mouth once a day. During the first cycle, they will have blood work done once a week (4 weeks). On cycles thereafter they will have blood work on days 7 and 21. Once a month, the patient will have a chest x-ray. Every 8 weeks the patient will have a CT scan of the chest, abdomen and pelvis. If clinically indicated, additional tests will be done.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must have predominantly clear cell renal cancer (75%)
•Patients must have evidence of metastatic disease. Metastatic disease should not be progressing so as to require palliative treatment (e.g., radiation, surgery, etc), within 4 weeks of enrollment.
•Patients may have received no more than two prior regimens such as immunotherapy, chemotherapy or molecular targeted agents for renal cell carcinoma with at least 1 regimen consisting of a tyrosine kinase inhibitor (sorafenib or sunitinib). Four weeks must have elapsed from previous therapy.
•Patients must have adequate physiologic reserves as evidenced by lab values
•Effective birth control must be practiced by both male and female patients

Exclusion Criteria

•Patients with central nervous system metastases are excluded, except those patients who have had complete excision or radiotherapy and remain asymptomatic, off steroids for 21 days, with no evidence of new disease as shown by MRI
•Patients with active autoimmune disease.
•Patients who have had steroid therapy within the past three weeks.
•Patients involving concurrent anticancer drug therapy. Any immunosuppressive drugs or any other experimental therapy.
•Female patients who are pregnant or lactating.
•The patient has an unstable medical condition, such as uncontrolled diabetes mellitus or hypertension; active infections requiring systemic antibiotics, antivirals, or antifungals; clinical evidence of cardiac or pulmonary dysfunction including, but not limited to: unstable CHF; uncontrolled arrhythmias; unstable coagulation disorders; or recent myocardial infarction (within 6 months).
•The patient has received any investigational agent(s) within 4 weeks of study entry.
•Patients with evidence of mucosal or internal bleeding and/or platelet refractory (i.e., unable to maintain a platelet count \> 50,000 cells/mm3).
•Patients unable to maintain an absolute neutrophil count (ANC) of \< 1,500 cells/mm3.
•Any condition, including laboratory abnormalities, that in the opinion of the Investigator places the patient at unacceptable risk if he/she were to participate in the study.
+1 more criteria

Locations (1)

Baylor College of Medicine - Methodist Hospital

Houston, Texas, United States

Key Dates

Start Date

May 1, 2005

Primary Completion Date

September 1, 2008

Completion Date

October 1, 2008

Last Updated

March 17, 2016

Enrollment

ACTUAL participants

Conditions

Carcinoma, Renal Cell

Interventions

RAD001

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 17, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety Study of RAD001 to Treat Patients With Metastatic Kidney Cancer

Inclusion Criteria

Exclusion Criteria

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