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

NCT00529802 | Completed Phase 2 Results DMC

• 1 other identifier: 15599B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Carcinoma, Renal Cell

Keywords

metastatic; renal; cell; carcinoma; cancer

Outcome Measures

Primary Outcomes (1)

• Relative Tumor Size Change Following 8 Weeks of Therapy.

  The primary objective is to determine whether high SUV uptake on FDG-PET is associated with greater tumor shrinkage. Tumor size is defined as the sum of unidimensional tumor measurements from standard CT imaging calculated according to RECIST criteria. Tumor size is measured at baseline and after eight weeks of therapy. Tumor shrinkage is the relative change (%) in tumor size from baseline.

  8 weeks

Secondary Outcomes (1)

• Percent Change in FDG-PETUptake Following 2 Weeks of Therapy

  2 weeks

Study Arms (1)

Everolimus (RAD001) 10mg daily

EXPERIMENTAL

All patients were to receive 10mg everolimus (RAD001) daily.

Drug: RAD001

Interventions

RAD001 DRUG

take 2 tablets of RAD001 once a day by mouth (10 mg per day)

Everolimus (RAD001) 10mg daily

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead
• Novartis: collaborator

Study Sites (5)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Oncology/Hematology Associates

Peoria, Illinois, 61615, United States

Location

Beth Israel Deaconess Med Ctr

Boston, Massachusetts, 02215, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

The University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Chen JL, Appelbaum DE, Kocherginsky M, Cowey CL, Rathmell WK, McDermott DF, Stadler WM. FDG-PET as a predictive biomarker for therapy with everolimus in metastatic renal cell cancer. Cancer Med. 2013 Aug;2(4):545-52. doi: 10.1002/cam4.102. Epub 2013 Jul 10.

  PMID: 24156027 RESULT

Related Links

• Study results publication available through PMC

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis; Carcinoma; Neoplasms

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Adenocarcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Walter Stadler, MD
• Organization: The University of Chicago

wstadler@medicine.bsd.uchicago.edu

(773) 702-4150

Study Officials

• Walter Stadler, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2007
• First Posted: September 14, 2007
• Study Start: September 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: April 25, 2018
• Results First Posted: November 9, 2017

Record last verified: 2018-03

Locations

US (5)