Safety Study of RAD001 to Treat Patients With Metastatic Kidney Cancer (RAD001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00446368
Recruitment Status : Completed
First Posted : March 12, 2007
Last Update Posted : March 17, 2016
Information provided by (Responsible Party):
The Methodist Hospital System

Brief 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.

Condition or disease Intervention/treatment Phase
Carcinoma, Renal Cell Drug: RAD001 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of RAD001 (Everolimus) in Patient's With Metastatic Renal Cell Cancer
Study Start Date : May 2005
Actual Primary Completion Date : September 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: RAD001
Subjects will take RAD001 (Everolimus) 10mg by mouth daily.
Drug: RAD001
Participant will take RAD001 (Everolimus) 10mg by mouth once a day.
Other Name: Everolimus

Primary Outcome Measures :
  1. To collect data on time to tumor progression produced by the study treatment. [ Time Frame: restaging every 8 weeks ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: restaging every 8 weeks ]
  2. Duration of tumor response [ Time Frame: restaging every 8 weeks ]
  3. Safety and toxicity [ Time Frame: AEs as occur ]
  4. Six month and 12 month survival rate [ Time Frame: at 6 months and at 12 months ]
  5. Overall survival [ Time Frame: restaging every 8 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 known to be HIV positive are not eligible, although testing specifically for participation in this protocol is not required.
  • Patients with a recent history of TIA (within 6 months), or are requiring regular antianginal therapy or are having claudication sufficient to limit activity are not eligible. Patients with a previous history of deep venous thrombosis or pulmonary embolism are not eligible.
  • 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.
  • Prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for at least 3 years.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00446368

United States, Texas
Baylor College of Medicine - Methodist Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The Methodist Hospital System
Principal Investigator: Robert J Amato, DO Baylor College of Medicine - Methodist Hospital

Additional Information:
Responsible Party: The Methodist Hospital System Identifier: NCT00446368     History of Changes
Other Study ID Numbers: PAC IRB#03-0183-05
RCC-RAD-01 ( Other Identifier: Novartis )
First Posted: March 12, 2007    Key Record Dates
Last Update Posted: March 17, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by The Methodist Hospital System:
metastatic kidney cancer
metastatic renal cell cancer

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents