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Melanoma (Skin)Phase 2NCT00098553

Everolimus in Treating Patients With Stage IV Melanoma

A Phase 2 study testing everolimus in people with Melanoma (Skin), run by Alliance for Clinical Trials in Oncology at 94 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin)
What is being tested?
everolimus
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
94 sitesUnited States
Study dates
Apr 2005to Feb 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

94 sites in 1 country.

94 sites in 1 country

United States94 sites

  • Study site

    Alexandria, Minnesota, 56308

  • Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest

    Allentown, Pennsylvania, 18105

  • McFarland Clinic, PC

    Ames, Iowa, 50010

  • AnMed Cancer Center

    Anderson, South Carolina, 29621

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • MeritCare Clinic - Bemidji

    Bemidji, Minnesota, 56601

  • Study site

    Bettendorf, Iowa, 52722

  • Bismarck Cancer Center

    Bismarck, North Dakota, 58501

  • Medcenter One Hospital Cancer Care Center

    Bismarck, North Dakota, 58501

  • Mid Dakota Clinic, PC

    Bismarck, North Dakota, 58501

  • St. Alexius Medical Center Cancer Center

    Bismarck, North Dakota, 58502

  • Brainerd Medical Center

    Brainerd, Minnesota, 56401

  • St. Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Cancer Center of Kansas, PA - Chanute

    Chanute, Kansas, 66720

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Mercy Capitol Hospital

    Des Moines, Iowa, 50307

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309

  • John Stoddard Cancer Center at Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates at Mercy Cancer Center

    Des Moines, Iowa, 50314

  • Mercy Cancer Center at Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • John Stoddard Cancer Center at Iowa Lutheran Hospital

    Des Moines, Iowa, 50316-2301

  • Cancer Center of Kansas, PA - Dodge City

    Dodge City, Kansas, 67801

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas, PA - El Dorado

    El Dorado, Kansas, 67042

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • MeritCare Broadway

    Fargo, North Dakota, 58122

  • Study site

    Fergus Falls, Minnesota, 56537

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Green Bay Oncology, Limited at St. Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center - Green Bay

    Green Bay, Wisconsin, 54303

  • St. Vincent Hospital Regional Cancer Center

    Green Bay, Wisconsin, 54307-3508

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Green Bay Oncology, Limited - Iron Mountain

    Iron Mountain, Michigan, 49801

  • Mayo Clinic - Jacksonville

    Jacksonville, Florida, 32224

  • Joliet Oncology-Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Cancer Center of Kansas, PA - Kingman

    Kingman, Kansas, 67068

  • Franciscan Skemp Healthcare - La Crosse Campus

    La Crosse, Wisconsin, 54601

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Meeker County Memorial Hospital

    Lichfield, Minnesota, 55355

  • HealthEast Cancer Care at St. John's Hospital

    Maplewood, Minnesota, 55109

  • Bay Area Cancer Care Center at Bay Area Medical Center

    Marinette, Wisconsin, 54143

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Trinity Medical Center - East

    Moline, Illinois, 61265

  • Study site

    Moline, Illinois, 61265

  • Chippewa County - Montevideo Hospital

    Montevideo, Minnesota, 56265

  • Cancer Center of Kansas, PA - Newton

    Newton, Kansas, 67114

  • Green Bay Oncology, Limited - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • McCreery Cancer Center at Ottumwa Regional

    Ottumwa, Iowa, 52501

  • Cancer Center of Kansas, PA - Parsons

    Parsons, Kansas, 67357

  • Cancer Center of Kansas, PA - Pratt

    Pratt, Kansas, 67124

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Hubert H. Humphrey Cancer Center at North Memorial Medical Center

    Robbinsdale, Minnesota, 55422-2900

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • CentraCare Clinic - River Campus

    Saint Cloud, Minnesota, 56303

  • Coborn Cancer Center

    Saint Cloud, Minnesota, 56303

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Health Services

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • St. Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas, PA - Salina

    Salina, Kansas, 67042

  • Adult and Pediatric Urology, P.L.L.P.

    Sartell, Minnesota, 56377

  • Mayo Clinic Scottsdale

    Scottsdale, Arizona, 85259-5499

  • Saint Francis Cancer Center

    Shakopee, Minnesota, 55379

  • Siouxland Hematology-Oncology Associates, LLP

    Sioux City, Iowa, 51101

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51104

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Medical X-Ray Center, PC

    Sioux Falls, South Dakota, 57105

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57117-5039

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Green Bay Oncology, Limited - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Cancer Center of Kansas, PA - Wellington

    Wellington, Kansas, 67152

  • Medical Oncology and Hematology Associates - West Des Moines

    West Des Moines, Iowa, 50266

  • Associates in Womens Health, PA - North Review

    Wichita, Kansas, 67203

  • Cancer Center of Kansas, PA - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, PA - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Cancer Center of Kansas, PA - Winfield

    Winfield, Kansas, 67156

  • Woodwinds Health Campus

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Melanoma (Skin)
Being tested
everolimus
Keywords
stage IV melanoma, recurrent melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00098553
Study groupRoleWhat they receive
everolimusExperimentalPatients 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.
Receives: Drug: everolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with progression-free disease at 16 weeks

    Measured: at 16 weeks

Secondary outcomes (4)

  1. Median overall survival

    Measured: Up to 5 years

  2. Tumor response rate for 2 consecutive evaluations at least 8 weeks apart

    Measured: Up to 5 years

  3. Toxicity as measured by CTCAE v. 3.0

    Measured: Up to 5 years

  4. disease progression

    Measured: at 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2004 (estimated)
  2. Study startApr 2005
  3. Primary completionJul 2007
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00098553
Sponsor's protocol ID
NCCTG-N0377
Other IDs
NCI-2012-02640, CDR0000402871
Status last verified
Jul 2016
First submitted
7 Dec 2004
Last updated
6 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Rao RD, Allred JB, Windschitl HE, et al.: N0377: results of NCCTG phase II trial of the mTOR inhibitor RAD-001 in metastatic melanoma. [Abstract] J Clin Oncol 25 (Suppl 18): A-8530, 479s, 2007.

  • Rao RD, Windschitl HE, Allred JB, et al.: Phase II trial of the mTOR inhibitor everolimus (RAD-001) in metastatic melanoma. [Abstract] J Clin Oncol 24 (Suppl 18): A-8043, 463s, 2006.

  • Vera Aguilera J, Rao RD, Allred JB, Suman VJ, Windschitl HE, Kaur JS, Maples WJ, Lowe VJ, Creagan ET, Erickson LA, Markovic S. Phase II Study of Everolimus in Metastatic Malignant Melanoma (NCCTG-N0377, Alliance). Oncologist. 2018 Aug;23(8):887-e94. doi: 10.1634/theoncologist.2018-0100. Epub 2018 Apr 17.

    PubMed 29666297

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing everolimus in people with Melanoma (Skin), run by Alliance for Clinical Trials in Oncology at 94 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 94 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with progression-free disease at 16 weeks (time frame: at 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00098553, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2016.

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