Everolimus in Treating Patients With Stage IV Melanoma

July 1, 2016 updated by: Alliance for Clinical Trials in Oncology

Phase II Trial Of RAD-001 In Metastatic Malignant Melanoma

RATIONALE: Drugs used in chemotherapy, such as everolimus, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Everolimus may also stop the growth of melanoma by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with stage IV melanoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the median time to disease progression in patients with stage IV malignant melanoma treated with everolimus.

Secondary

  • Determine the median overall survival of patients treated with this drug.
  • Determine the clinical benefit rates (i.e., stable disease, partial remission, and complete response rates) in patients treated with this drug.
  • Determine the toxicity profile of this drug in these patients.
  • Determine changes in serum vascular endothelial growth factor levels in patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive oral everolimus once daily for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months until disease progression and then every 4 months for up to 5 years after registration.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259-5499
        • Mayo Clinic Scottsdale
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic - Jacksonville
    • Illinois
      • Aurora, Illinois, United States, 60507
        • Rush-Copley Cancer Care Center
      • Joliet, Illinois, United States, 60435
        • Joliet Oncology-Hematology Associates, Limited - West
      • Moline, Illinois, United States, 61265
      • Moline, Illinois, United States, 61265
        • Trinity Medical Center - East
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center at Carle Foundation Hospital
      • Urbana, Illinois, United States, 61801
        • CCOP - Carle Cancer Center
    • Indiana
      • Michigan City, Indiana, United States, 46360
        • Saint Anthony Memorial Health Centers
    • Iowa
      • Ames, Iowa, United States, 50010
        • McFarland Clinic, PC
      • Bettendorf, Iowa, United States, 52722
      • Des Moines, Iowa, United States, 50309
        • CCOP - Iowa Oncology Research Association
      • Des Moines, Iowa, United States, 50309
        • John Stoddard Cancer Center at Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50309
        • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
      • Des Moines, Iowa, United States, 50314
        • Medical Oncology and Hematology Associates at Mercy Cancer Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Cancer Center at Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50307
        • Mercy Capitol Hospital
      • Des Moines, Iowa, United States, 50316-2301
        • John Stoddard Cancer Center at Iowa Lutheran Hospital
      • Ottumwa, Iowa, United States, 52501
        • McCreery Cancer Center at Ottumwa Regional
      • Sioux City, Iowa, United States, 51101
        • Siouxland Regional Cancer Center
      • Sioux City, Iowa, United States, 51101
        • Siouxland Hematology-Oncology Associates, LLP
      • Sioux City, Iowa, United States, 51104
        • St. Luke's Regional Medical Center
      • Sioux City, Iowa, United States, 51104
        • Mercy Medical Center - Sioux City
      • West Des Moines, Iowa, United States, 50266
        • Medical Oncology and Hematology Associates - West Des Moines
    • Kansas
      • Chanute, Kansas, United States, 66720
        • Cancer Center of Kansas, PA - Chanute
      • Dodge City, Kansas, United States, 67801
        • Cancer Center of Kansas, PA - Dodge City
      • El Dorado, Kansas, United States, 67042
        • Cancer Center of Kansas, PA - El Dorado
      • Kingman, Kansas, United States, 67068
        • Cancer Center of Kansas, PA - Kingman
      • Liberal, Kansas, United States, 67901
        • Southwest Medical Center
      • Newton, Kansas, United States, 67114
        • Cancer Center of Kansas, PA - Newton
      • Parsons, Kansas, United States, 67357
        • Cancer Center of Kansas, PA - Parsons
      • Pratt, Kansas, United States, 67124
        • Cancer Center of Kansas, PA - Pratt
      • Salina, Kansas, United States, 67042
        • Cancer Center of Kansas, PA - Salina
      • Wellington, Kansas, United States, 67152
        • Cancer Center of Kansas, PA - Wellington
      • Wichita, Kansas, United States, 67203
        • Associates in Womens Health, PA - North Review
      • Wichita, Kansas, United States, 67208
        • Cancer Center of Kansas, PA - Medical Arts Tower
      • Wichita, Kansas, United States, 67214
        • Cancer Center of Kansas, PA - Wichita
      • Wichita, Kansas, United States, 67214
        • CCOP - Wichita
      • Wichita, Kansas, United States, 67214
        • Via Christi Cancer Center at Via Christi Regional Medical Center
      • Winfield, Kansas, United States, 67156
        • Cancer Center of Kansas, PA - Winfield
    • Michigan
      • Escanaba, Michigan, United States, 49431
        • Green Bay Oncology, Limited - Escanaba
      • Iron Mountain, Michigan, United States, 49801
        • Green Bay Oncology, Limited - Iron Mountain
    • Minnesota
      • Alexandria, Minnesota, United States, 56308
      • Bemidji, Minnesota, United States, 56601
        • MeritCare Clinic - Bemidji
      • Brainerd, Minnesota, United States, 56401
        • Brainerd Medical Center
      • Brainerd, Minnesota, United States, 56401
        • St. Joseph's Medical Center
      • Burnsville, Minnesota, United States, 55337
        • Fairview Ridges Hospital
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy and Unity Cancer Center at Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fergus Falls, Minnesota, United States, 56537
      • Fridley, Minnesota, United States, 55432
        • Mercy and Unity Cancer Center at Unity Hospital
      • Hutchinson, Minnesota, United States, 55350
        • Hutchinson Area Health Care
      • Lichfield, Minnesota, United States, 55355
        • Meeker County Memorial Hospital
      • Maplewood, Minnesota, United States, 55109
        • HealthEast Cancer Care at St. John's Hospital
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center - Minneapolis
      • Minneapolis, Minnesota, United States, 55407
        • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
      • Montevideo, Minnesota, United States, 56265
        • Chippewa County - Montevideo Hospital
      • Robbinsdale, Minnesota, United States, 55422-2900
        • Hubert H. Humphrey Cancer Center at North Memorial Medical Center
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
      • Saint Cloud, Minnesota, United States, 56303
        • Coborn Cancer Center
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
      • Sartell, Minnesota, United States, 56377
        • Adult and Pediatric Urology, P.L.L.P.
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Cancer Center
      • St Paul, Minnesota, United States, 55102
        • St. Joseph's Hospital
      • St. Cloud, Minnesota, United States, 56303
        • CentraCare Clinic - River Campus
      • St. Louis Park, Minnesota, United States, 55416
        • Park Nicollet Health Services
      • St. Paul, Minnesota, United States, 55102
        • United Hospital
      • St. Paul, Minnesota, United States, 55101
        • Regions Hospital Cancer Care Center
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Woodbury, Minnesota, United States, 55125
        • Woodwinds Health Campus
    • North Carolina
      • Rutherfordton, North Carolina, United States, 28139
        • Rutherford Hospital
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Bismarck Cancer Center
      • Bismarck, North Dakota, United States, 58501
        • Medcenter One Hospital Cancer Care Center
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic, PC
      • Bismarck, North Dakota, United States, 58502
        • St. Alexius Medical Center Cancer Center
      • Fargo, North Dakota, United States, 58122
        • CCOP - MeritCare Hospital
      • Fargo, North Dakota, United States, 58122
        • MeritCare Broadway
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Natalie Warren Bryant Cancer Center at St. Francis Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18105
        • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • AnMed Cancer Center
      • Spartanburg, South Carolina, United States, 29303
        • CCOP - Upstate Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Rapid City Regional Hospital
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute
      • Sioux Falls, South Dakota, United States, 57117-5039
        • Sioux Valley Hospital and University of South Dakota Medical Center
      • Sioux Falls, South Dakota, United States, 57105
        • Medical X-Ray Center, PC
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54307-3508
        • St. Vincent Hospital Regional Cancer Center
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital
      • Green Bay, Wisconsin, United States, 54303
        • St. Mary's Hospital Medical Center - Green Bay
      • Green Bay, Wisconsin, United States, 54301-3526
        • Green Bay Oncology, Limited at St. Vincent Hospital
      • La Crosse, Wisconsin, United States, 54601
        • Franciscan Skemp Healthcare - La Crosse Campus
      • Marinette, Wisconsin, United States, 54143
        • Bay Area Cancer Care Center at Bay Area Medical Center
      • Oconto Falls, Wisconsin, United States, 54154
        • Green Bay Oncology, Limited - Oconto Falls
      • Sturgeon Bay, Wisconsin, United States, 54235
        • Green Bay Oncology, Limited - Sturgeon Bay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant melanoma for which no known standard or potentially curative therapy exists or has been proven to extend life expectancy

    • Stage IV disease

  • Measurable disease

    • At least 1 lesion ≥ 20 mm by CT scan or MRI OR ≥ 10 mm by spiral CT scan
  • No intracranial disease

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • No bleeding diathesis

Hepatic

  • AST ≤ 3 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 3 ULN
  • INR ≤ 1.5

Renal

  • Creatinine ≤ 1.5 times ULN

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Willing to refrain from foods high in fat content
  • No uncontrolled infection
  • No immunosuppression from any cause (e.g., known HIV infection)
  • No other malignancy within the past 5 years except basal cell or squamous cell skin cancer treated with local resection only
  • No other severe condition that would preclude study participation or compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior immunotherapy or biologic therapy

Chemotherapy

  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
  • No prior sirolimus or its analogues for any indication
  • No other concurrent chemotherapy

Endocrine therapy

  • No concurrent steroids

Radiotherapy

  • More than 4 weeks since prior radiotherapy to head and neck area
  • More than 4 weeks since prior radiosurgery
  • No prior radiotherapy to > 30% of bone marrow
  • No concurrent radiotherapy

Surgery

  • Not specified

Other

  • At least 1 week since prior and no concurrent CYP3A4 inducers
  • No concurrent warfarin
  • No concurrent cytotoxic agents
  • No other concurrent experimental drugs
  • No other concurrent immunosuppressive therapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: everolimus

Patients receive oral everolimus once daily for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months until disease progression and then every 4 months for up to 5 years after registration.
Drug: everolimus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients with progression-free disease at 16 weeks
Time Frame: at 16 weeks
at 16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Median overall survival
Time Frame: Up to 5 years
Up to 5 years
Tumor response rate for 2 consecutive evaluations at least 8 weeks apart
Time Frame: Up to 5 years
Up to 5 years
Toxicity as measured by CTCAE v. 3.0
Time Frame: Up to 5 years
Up to 5 years
disease progression
Time Frame: at 16 weeks
at 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alliance for Clinical Trials in Oncology

Collaborators

National Cancer Institute (NCI)

Investigators

  • Harold E. Windschitl, MD, Coborn Cancer Center
  • William J. Maples, MD, Mayo Clinic
  • Michael K. Gornet, MD, Mayo Clinic
  • James N. Ingle, MD, Mayo Clinic
  • Edward T. Creagan, MD, Mayo Clinic
  • Judith S. Kaur, MD, Mayo Clinic
  • Barbara A. Pockaj, MD, Mayo Clinic Hospital
  • Evanthia Galanis, MD, Mayo Clinic
  • Charles L. Loprinzi, MD, Mayo Clinic
  • Henry C. Pitot, MD, Mayo Clinic
  • Lori A. Erickson, MD, Mayo Clinic
  • Val J. Lowe, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

July 1, 2007

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

December 7, 2004

First Submitted That Met QC Criteria

December 7, 2004

First Posted (Estimate)

December 8, 2004

Study Record Updates

Last Update Posted (Estimate)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 1, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCTG-N0377
  • NCI-2012-02640 (Registry Identifier: CTRP (Clinical Trials Reporting System))
  • CDR0000402871 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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