Everolimus in Treating Patients With Stage IV Melanoma



Status:Completed
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:April 2005
End Date:February 2010

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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.

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.

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
We found this trial at
94
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1323 N. A
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(620) 326-7453 Ext. 224
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1174
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1200 S Cedar Crest Blvd
Allentown, Pennsylvania 18103
(610) 402-8000
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2353
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1920 Libal Street
Green Bay, Wisconsin 54307
(920) 433-8889
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1745
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3900 W Avera Drive
Sioux Falls, South Dakota 57108
(605) 322-4700
Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
1314
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825 N Emporia Ave
Wichita, Kansas 67214
(316) 261-3200
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1182
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1441
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Alexandria, MN
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Ames, Iowa 50010
McFarland Clinic, PC It has been over 65 years since the founders of McFarland Clinic...
1430
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Ames, IA
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Anderson, South Carolina 29621
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Anderson, SC
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Aurora, Illinois 60507
1696
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Aurora, IL
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Bemidji, Minnesota 56601
1514
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Bemidji, MN
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1580
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Bettendorf, IA
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500 N 8th St
Bismarck, North Dakota 58501
(701) 222-6100
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1259
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1259
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900 E Broadway Ave
Bismarck, North Dakota 58501
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900 East Broadway
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1264
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Brainerd, Minnesota 56401
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Burnsville, Minnesota 55337
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505 S Plummer Ave
Chanute, Kansas 66720
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Coon Rapids, Minnesota 55433
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1221 Pleasant St
Des Moines, Iowa 50309
(515) 241-4141
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Des Moines, Iowa 50309
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2020 Central Ave
Dodge City, Kansas 67801
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6401 France Ave S
Edina, Minnesota 55435
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700 West Central
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1209
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Escanaba, Michigan 49431
1815
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820 4th Street North
Fargo, North Dakota 58122
(701) 234-6292
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1400
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801 Broadway N
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1424
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Fergus Falls, MN
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550 Osborne Road
Fridley, Minnesota 55432
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1744
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1095 Minnesota 15
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(320) 234-5000
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Iron Mountain, Michigan 49801
1767
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Jacksonville, Florida 32216
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Jacksonville, FL
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1701
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Joliet, IL
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750 Avenue D West
Kingman, Kansas 67068
(620) 532-3147
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1579
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Liberal, Kansas 67901
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Lichfield, Minnesota 55355
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1575 Beam Avenue
Maplewood, Minnesota 55109
651-232-7970
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3100 Shore Dr.
Marinette, Wisconsin 54143
715.735.6621
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1773
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301 W Homer St
Michigan City, Indiana 46360
(219) 879-8511
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1766
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800 E 28th St
Minneapolis, Minnesota 55407
612-863-4000
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1509
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701 Park Ave
Minneapolis, Minnesota 55415
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Moline, IL
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Moline, Illinois 61265
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720 Medical Center Drive
Newton, Kansas 67114
(316) 282-0888
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Oconto Falls, Wisconsin 54154
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Oconto Falls, WI
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1001 PENNSYLVANIA AVENUE
Ottumwa, Iowa 52501
641.684.2300
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1902 S. US Hwy 59
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(620) 421-2855
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124 Commodore, Ste. A
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(620) 672-2478
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1104
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353 Fairmont Blvd
Rapid City, South Dakota 57701
(605) 719-1000
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1049
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1508
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Robbinsdale, MN
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
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288 S. Ridgecrest Ave
Rutherfordton, North Carolina 28139
(828) 286-5000
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2036
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1900 Centracare Cir
Saint Cloud, Minnesota 56303
(320) 229-4907
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1484
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Saint Cloud, MN
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Saint Louis Park, Minnesota 55416
1505
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Saint Louis Park, MN
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600 S Santa Fe Ave
Salina, Kansas 67401
(785) 823-1521
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1177
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Sartell, Minnesota 56377
1484
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Sartell, MN
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5777 E Mayo Blvd
Scottsdale, Arizona 85259
(480) 515-6296
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356
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Shakopee, Minnesota 55379
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Shakopee, MN
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801 5th St
Sioux City, Iowa 51104
(712) 279-2010
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230 Nebraska St.
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2720 Stone Park Blvd
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Sioux City, Iowa 51101
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Sioux Falls, South Dakota 57105
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Spartanburg, South Carolina 29303
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101 E Wood St
Spartanburg, South Carolina 29303
(864) 560-6000
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St. Paul, Minnesota 55101
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Urbana, Illinois 61801
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500 S Maple Street
Waconia, Minnesota 55387
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1412
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Wichita, KS
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Wichita, Kansas 67214
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Wichita, KS
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8710 W 13th St N # 100
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1184
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