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Everolimus in Treating Patients With Stage IV Melanoma

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00098553
Collaborator
National Cancer Institute (NCI) (NIH)
53
Enrollment
94
Locations
1
Arm
58.1
Duration (Months)
0.6
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
53 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Trial Of RAD-001 In Metastatic Malignant Melanoma
Study Start Date :
Apr 1, 2005
Actual Primary Completion Date :
Jul 1, 2007
Actual Study Completion Date :
Feb 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

  1. Median overall survival [Up to 5 years]

  2. Tumor response rate for 2 consecutive evaluations at least 8 weeks apart [Up to 5 years]

  3. Toxicity as measured by CTCAE v. 3.0 [Up to 5 years]

  4. disease progression [at 16 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Scottsdale Scottsdale Arizona United States 85259-5499
2 Mayo Clinic - Jacksonville Jacksonville Florida United States 32224
3 Rush-Copley Cancer Care Center Aurora Illinois United States 60507
4 Joliet Oncology-Hematology Associates, Limited - West Joliet Illinois United States 60435
5 Trinity Medical Center - East Moline Illinois United States 61265
6 Moline Illinois United States 61265
7 Carle Cancer Center at Carle Foundation Hospital Urbana Illinois United States 61801
8 CCOP - Carle Cancer Center Urbana Illinois United States 61801
9 Saint Anthony Memorial Health Centers Michigan City Indiana United States 46360
10 McFarland Clinic, PC Ames Iowa United States 50010
11 Bettendorf Iowa United States 52722
12 Mercy Capitol Hospital Des Moines Iowa United States 50307
13 CCOP - Iowa Oncology Research Association Des Moines Iowa United States 50309
14 John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa United States 50309
15 Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa United States 50309
16 Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa United States 50314
17 Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
18 John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines Iowa United States 50316-2301
19 McCreery Cancer Center at Ottumwa Regional Ottumwa Iowa United States 52501
20 Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa United States 51101
21 Siouxland Regional Cancer Center Sioux City Iowa United States 51101
22 Mercy Medical Center - Sioux City Sioux City Iowa United States 51104
23 St. Luke's Regional Medical Center Sioux City Iowa United States 51104
24 Medical Oncology and Hematology Associates - West Des Moines West Des Moines Iowa United States 50266
25 Cancer Center of Kansas, PA - Chanute Chanute Kansas United States 66720
26 Cancer Center of Kansas, PA - Dodge City Dodge City Kansas United States 67801
27 Cancer Center of Kansas, PA - El Dorado El Dorado Kansas United States 67042
28 Cancer Center of Kansas, PA - Kingman Kingman Kansas United States 67068
29 Southwest Medical Center Liberal Kansas United States 67901
30 Cancer Center of Kansas, PA - Newton Newton Kansas United States 67114
31 Cancer Center of Kansas, PA - Parsons Parsons Kansas United States 67357
32 Cancer Center of Kansas, PA - Pratt Pratt Kansas United States 67124
33 Cancer Center of Kansas, PA - Salina Salina Kansas United States 67042
34 Cancer Center of Kansas, PA - Wellington Wellington Kansas United States 67152
35 Associates in Womens Health, PA - North Review Wichita Kansas United States 67203
36 Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas United States 67208
37 Cancer Center of Kansas, PA - Wichita Wichita Kansas United States 67214
38 CCOP - Wichita Wichita Kansas United States 67214
39 Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas United States 67214
40 Cancer Center of Kansas, PA - Winfield Winfield Kansas United States 67156
41 Green Bay Oncology, Limited - Escanaba Escanaba Michigan United States 49431
42 Green Bay Oncology, Limited - Iron Mountain Iron Mountain Michigan United States 49801
43 Alexandria Minnesota United States 56308
44 MeritCare Clinic - Bemidji Bemidji Minnesota United States 56601
45 Brainerd Medical Center Brainerd Minnesota United States 56401
46 St. Joseph's Medical Center Brainerd Minnesota United States 56401
47 Fairview Ridges Hospital Burnsville Minnesota United States 55337
48 Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota United States 55433
49 Fairview Southdale Hospital Edina Minnesota United States 55435
50 Fergus Falls Minnesota United States 56537
51 Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota United States 55432
52 Hutchinson Area Health Care Hutchinson Minnesota United States 55350
53 Meeker County Memorial Hospital Lichfield Minnesota United States 55355
54 HealthEast Cancer Care at St. John's Hospital Maplewood Minnesota United States 55109
55 Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
56 Hennepin County Medical Center - Minneapolis Minneapolis Minnesota United States 55415
57 Chippewa County - Montevideo Hospital Montevideo Minnesota United States 56265
58 Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale Minnesota United States 55422-2900
59 Mayo Clinic Cancer Center Rochester Minnesota United States 55905
60 Coborn Cancer Center Saint Cloud Minnesota United States 56303
61 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
62 Adult and Pediatric Urology, P.L.L.P. Sartell Minnesota United States 56377
63 Saint Francis Cancer Center Shakopee Minnesota United States 55379
64 St. Joseph's Hospital St Paul Minnesota United States 55102
65 CentraCare Clinic - River Campus St. Cloud Minnesota United States 56303
66 Park Nicollet Health Services St. Louis Park Minnesota United States 55416
67 Regions Hospital Cancer Care Center St. Paul Minnesota United States 55101
68 United Hospital St. Paul Minnesota United States 55102
69 Ridgeview Medical Center Waconia Minnesota United States 55387
70 Woodwinds Health Campus Woodbury Minnesota United States 55125
71 Rutherford Hospital Rutherfordton North Carolina United States 28139
72 Bismarck Cancer Center Bismarck North Dakota United States 58501
73 Medcenter One Hospital Cancer Care Center Bismarck North Dakota United States 58501
74 Mid Dakota Clinic, PC Bismarck North Dakota United States 58501
75 St. Alexius Medical Center Cancer Center Bismarck North Dakota United States 58502
76 CCOP - MeritCare Hospital Fargo North Dakota United States 58122
77 MeritCare Broadway Fargo North Dakota United States 58122
78 Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa Oklahoma United States 74136
79 Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania United States 18105
80 AnMed Cancer Center Anderson South Carolina United States 29621
81 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
82 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
83 Rapid City Regional Hospital Rapid City South Dakota United States 57701
84 Avera Cancer Institute Sioux Falls South Dakota United States 57105
85 Medical X-Ray Center, PC Sioux Falls South Dakota United States 57105
86 Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls South Dakota United States 57117-5039
87 Green Bay Oncology, Limited at St. Vincent Hospital Green Bay Wisconsin United States 54301-3526
88 Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin United States 54303
89 St. Mary's Hospital Medical Center - Green Bay Green Bay Wisconsin United States 54303
90 St. Vincent Hospital Regional Cancer Center Green Bay Wisconsin United States 54307-3508
91 Franciscan Skemp Healthcare - La Crosse Campus La Crosse Wisconsin United States 54601
92 Bay Area Cancer Care Center at Bay Area Medical Center Marinette Wisconsin United States 54143
93 Green Bay Oncology, Limited - Oconto Falls Oconto Falls Wisconsin United States 54154
94 Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay Wisconsin United States 54235

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Ravi D. Rao, MD, MBBS, Mayo Clinic
  • : 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00098553
Other Study ID Numbers:
  • NCCTG-N0377
  • NCI-2012-02640
  • CDR0000402871
First Posted:
Dec 8, 2004
Last Update Posted:
Jul 6, 2016
Last Verified:
Jul 1, 2016
Keywords provided by Alliance for Clinical Trials in Oncology
stage IV melanoma
recurrent melanoma
Additional relevant MeSH terms:
Melanoma
Everolimus

Study Results

No Results Posted as of Jul 6, 2016