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Everolimus in Treating Patien...

Everolimus in Treating Patients With Stage IV Melanoma

Last Updated: 2016-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2010-02-28

Brief Summary

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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.

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Detailed Description

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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

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Melanoma (Skin)

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

everolimus

Intervention Type DRUG

Interventions

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everolimus

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ravi D. Rao, MD, MBBS

Role: STUDY_CHAIR

Mayo Clinic

Harold E. Windschitl, MD

Role:

Coborn Cancer Center

William J. Maples, MD

Role:

Mayo Clinic

Michael K. Gornet, MD

Role:

Mayo Clinic

James N. Ingle, MD

Role:

Mayo Clinic

Edward T. Creagan, MD

Role:

Mayo Clinic

Judith S. Kaur, MD

Role:

Mayo Clinic

Barbara A. Pockaj, MD

Role:

Mayo Clinic Hospital

Evanthia Galanis, MD

Role:

Mayo Clinic

Charles L. Loprinzi, MD

Role:

Mayo Clinic

Henry C. Pitot, MD

Role:

Mayo Clinic

Lori A. Erickson, MD

Role:

Mayo Clinic

Val J. Lowe, MD

Role:

Mayo Clinic

Locations

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Mayo Clinic Scottsdale

Scottsdale, Arizona, United States

Site Status

Mayo Clinic - Jacksonville

Jacksonville, Florida, United States

Site Status

Rush-Copley Cancer Care Center

Aurora, Illinois, United States

Site Status

Joliet Oncology-Hematology Associates, Limited - West

Joliet, Illinois, United States

Site Status

Trinity Medical Center - East

Moline, Illinois, United States

Site Status

Moline, Illinois, United States

Site Status

Carle Cancer Center at Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

CCOP - Carle Cancer Center

Urbana, Illinois, United States

Site Status

Saint Anthony Memorial Health Centers

Michigan City, Indiana, United States

Site Status

McFarland Clinic, PC

Ames, Iowa, United States

Site Status

Bettendorf, Iowa, United States

Site Status