Safety Study of RAD001 to Treat Patients With Metastatic Kidney Cancer

Carcinoma, Renal Cell Clinical Trial

— RAD001  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00446368
• Other study ID #: PAC IRB#03-0183-05
• Secondary ID: RCC-RAD-01
• Status: Completed
• Phase: Phase 2
• First received: March 9, 2007
• Last updated: March 15, 2016
• Start date: May 2005
• Est. completion date: October 2008

Study information

• Verified date: March 2016
• Source: The Methodist Hospital System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell

Intervention

Drug:
• RAD001
Participant will take RAD001 (Everolimus) 10mg by mouth once a day.

Locations

Country	Name	City	State
United States	Baylor College of Medicine - Methodist Hospital	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The Methodist Hospital System	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To collect data on time to tumor progression produced by the study treatment.		restaging every 8 weeks	No
Secondary	Response rate		restaging every 8 weeks	No
Secondary	Duration of tumor response		restaging every 8 weeks	No
Secondary	Safety and toxicity		AEs as occur	Yes
Secondary	Six month and 12 month survival rate		at 6 months and at 12 months	No
Secondary	Overall survival		restaging every 8 weeks	No

External Links

•   (click here for more information about the study)