NCT00831480

Brief Summary

The purpose of this multicenter, pilot, open-label, Phase II clinical trial is to discover if Everolimus(RAD001) is safe and effective in people who have advanced kidney cancer (renal cell carcinoma - RCC). Since 2002, Everolimus has been studied in more than 2500 patients with various types of cancer as a single agent (a drug that is used alone to treat the cancer) or in combination with a number of well known anticancer therapies. Various studies, in animals such as in mice with cancer and in humans with cancer have shown that Everolimus can slow the growth of cancer. Everolimus will be taken in pill form by mouth daily for 3-5 weeks followed by surgery to remove the effected kidney. After 2-4 weeks following the surgery, Everolimus will be resumed at the same dose.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2011

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 29, 2009

Completed
2.2 years until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 21, 2016

Completed
Last Updated

March 21, 2016

Status Verified

December 1, 2014

Enrollment Period

2.6 years

First QC Date

January 27, 2009

Results QC Date

November 20, 2014

Last Update Submit

February 19, 2016

Conditions

Kidney Cancer

Keywords

Renal cell carcinomaEverolimusNeoadjuvantadvanced kidney cancer

Outcome Measures

Primary Outcomes (1)

  • Disease Progression Diagnosed by Biopsy

    Clinical progression validated by biopsy of metastatic site. Progression-free survival (PFS) will be measured from the post-op treatment start date to either the date the patient is first recorded as having disease progression, or the date of death if the patient dies due to any causes before progression. If a patient is lost to follow-up or removed for toxicities, the patient will be censored as of the last date of contact. Patients who start a new treatment before they progress will be censored as of the date of start of the new treatment. If a patient has not progressed or died, PFS is censored at the date of last follow-up. Patients removed from therapy with everolimus due to toxicities will not be included in the PFS estimation.

    up to one year

Study Arms (1)

1

EXPERIMENTAL

All subjects will take everolimus

Drug: everolimus

Interventions

everolimusDRUG

everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery.

Also known as: RAD001, Afinitor
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Advanced (metastatic) RCC
  • Histology: clear cell, papillary or chromophobe
  • out 6 risk factors (by Memorial Sloan Kettering Cancer Center criteria and one additional criterion: multiple sites of metastasis) or not candidates for or refuse sunitinib.
  • Must have at least one measurable metastatic site according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria that has not been previously irradiated.
  • Must be deemed surgical candidates for cytoreductive nephrectomy by the urologist.
  • Age 18 years of age or older
  • Eastern Cooperative Oncology Group (EGOG) PS 0-2
  • Adequate bone marrow function
  • Adequate liver function as shown by:
  • Adequate renal function
  • Fasting serum cholesterol AND fasting triglycerides within normal limits
  • Signed informed consent

You may not qualify if:

  • Collecting duct, medullary histologies or sarcomatoid differentiation.
  • Central Nervous System (CNS) or leptomeningeal metastases.
  • Inappropriate candidates for cytoreductive nephrectomy or who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
  • severely impaired lung function
  • uncontrolled diabetes
  • active (acute or chronic) or uncontrolled severe infections
  • liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis
  • Ineligible for cytoreductive nephrectomy
  • Current or prior systemic anticancer therapies (including chemotherapy, antibody based therapy, or investigational drugs)
  • Other malignancies within the past 3 years except for localized carcinoma of the cervix, basal or squamous cell carcinomas of the skin, or localized prostate cancer with Gleason Score less than 7 treated with radiation or surgery and no evidence of progression.
  • Major surgery (defined as requiring general anesthesia) or significant traumatic injury within 4 weeks of start of enrollment
  • Anticipated major surgery (other than CN) during the course of the study
  • A known history of HIV seropositivity
  • Hepatitis C seropositivity
  • Chronic, systemic treatment with corticosteroids or another immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

Everolimus

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Results Point of Contact

Title
Dr. Gilad E. Amiel
Organization
Baylor College of Medicine
lhiggins@bcm.edu
713-798-4079

Study Officials

  • Gilad E. Amiel, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Study Contact

Study Record Dates

First Submitted

January 27, 2009

First Posted

January 29, 2009

Study Start

April 1, 2011

Primary Completion

November 1, 2013

Study Completion

December 1, 2014

Last Updated

March 21, 2016

Results First Posted

March 21, 2016

Record last verified: 2014-12

Locations

US(2)