Exploratory Study Evaluating Fluorodeoxyglucose - Position Emission Tomography as a Predictive Marker for Therapy With RAD001 in Metastatic Renal Cell Cancer

The University of Chicago

Status and phase

Completed

Phase 2

Conditions

Carcinoma, Renal Cell

Treatments

Drug: RAD001

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00529802

15599B

Details and patient eligibility

About

The purpose of this study is to learn if PET scanning can predict the degree of tumor shrinkage with the study drug RAD001 in subjects who have advanced renal cancer.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Metastatic renal cancer refractory to sorafenib or sunitinib therapy
At least one measurable site of disease according to RECIST criteria that has not been previously irradiated.
18 years of age or older
Minimum of two weeks since any major surgery, completion of radiation, or completion of all prior standard systemic anticancer therapy and adequately recovered from the acute toxicities of any prior therapy.
World Health Organization (WHO) performance status <= 2
Adequate bone marrow function
Adequate liver function
Adequate creatinine clearance
Signed informed consent

Exclusion criteria

Prior treatment with any investigational drug within the previous 4 weeks
Chronic treatment with systemic steroids or another immunosuppressive agent
Uncontrolled brain or leptomeningeal metastases, including patients who continue to require glucocorticoids for brain or leptomeningeal metastases
Patients who have a history of another primary malignancy ≤ 3 years, with the exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
A known history of HIV seropositivity
Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of RAD001 (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection)
Patients with an active, bleeding diathesis or on oral anti-vitamin K medication
Women who are pregnant or breast feeding, or women/men able to conceive and unwilling to practice an effective method of birth control from enrollment through 6 months following the end of treatment
Patients who have received prior treatment with an mTOR inhibitor.
Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients
History of noncompliance to medical regimens
Patients unwilling to or unable to comply with the protocol