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S0508: Thalidomide and Temozolomide in Treating Patients With Stage IV Melanoma That Cannot Be Removed By Surgery

Sponsor
Southwest Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00104988
Collaborator
National Cancer Institute (NCI) (NIH)
64
Enrollment
132
Locations
1
Arm
50
Duration (Months)
0.5
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

RATIONALE: Thalidomide may stop the growth of melanoma by blocking blood flow to the tumor. It may also stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving thalidomide together with temozolomide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving thalidomide together with temozolomide works in treating patients with stage IV melanoma that cannot be removed by surgery.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

OBJECTIVES:

  • Determine the 6-month progression-free survival of patients with unresectable stage IV malignant cutaneous melanoma treated with thalidomide and temozolomide.

  • Determine the objective response (confirmed and unconfirmed complete response and partial response) in patients with measurable disease treated with this regimen.

  • Determine the overall survival of patients treated with this regimen.

  • Determine the qualitative and quantitative toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral thalidomide once daily on days 1-56 and temozolomide once daily on days 1-42. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed at week 9, every 2 months until disease progression, and then every 6 months until 3 years from study entry.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 14 months.

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Trial of Combination Thalidomide Plus Temozolomide in Patients With Metastatic Malignant Melanoma
Study Start Date :
Jun 1, 2005
Actual Primary Completion Date :
Jul 1, 2007
Actual Study Completion Date :
Aug 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Thalidomide and Temozolomide

Patients receive oral thalidomide once daily on days 1-56 and temozolomide once daily on days 1-42. Courses repeat every 56 days in the absence of disease progression or unacceptable toxicity.

Drug: temozolomide
75 mg/m^2/day PO daily for 6 weeks followed by a 2-week break

Drug: thalidomide
200 mg/day PO daily

Outcome Measures

Primary Outcome Measures

  1. Progression-free survival at 6 months [6 months after registration]

  2. Objective response (confirmed and unconfirmed complete and partial responses) [Week 9, every 8 weeks thereafter until progression]

  3. 6-month overall survival [six months after registration]

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 cutaneous melanoma

  • Unresectable, stage IV disease

  • Unknown primary allowed

  • Measurable or non-measurable disease

  • If all known sites of disease are within a previously irradiated port, disease progression must be clearly demonstrated

  • No brain metastases by CT scan or MRI within the past 42 days

  • Prior brain metastasis allowed provided both of the following criteria are met:

  • Completely resected and free of disease

  • Treated with whole brain radiotherapy and completed treatment at least 28 days ago

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,000/mm^3

  • Platelet count ≥ 100,000/mm^3

  • Hemoglobin ≥ 9 g/dL (transfusions allowed)

Hepatic

  • Bilirubin ≤ 3 times upper limit of normal (ULN)

  • SGOT or SGPT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)

Renal

  • Creatinine ≤ 1.5 times ULN

Other

  • Not pregnant or nursing

  • Negative pregnancy test

  • Fertile patients must use effective double-method contraception for 4 weeks before, during, and for 4 weeks after study participation

  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission

  • No history of allergic reaction to dacarbazine

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior thalidomide for stage IV disease

  • At least 28 days since prior biological therapy

  • At least 28 days since prior immunotherapy

  • At least 28 days since prior adjuvant interferon alfa

Chemotherapy

  • No prior temozolomide or dacarbazine for stage IV disease

  • At least 28 days since prior chemotherapy

Endocrine therapy

  • At least 28 days since prior hormonal therapy

Radiotherapy

  • See Disease Characteristics

  • At least 28 days since prior radiotherapy

Surgery

  • See Disease Characteristics

  • At least 28 days since prior surgery for primary and stage IV disease

Other

  • No more than 1 prior systemic therapy regimen for stage IV disease

  • At least 28 days since other prior systemic therapy

Contacts and Locations

Locations

Site City State Country Postal Code
1 Alaska Regional Hospital Cancer Center Anchorage Alaska United States 99508
2 Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock Arkansas United States 72205
3 Eden Medical Center Castro Valley California United States 94546
4 North Bay Cancer Center Fairfield California United States 94533
5 Saint Rose Hospital Hayward California United States 94545
6 USC/Norris Comprehensive Cancer Center and Hospital Los Angeles California United States 90089-9181
7 Highland General Hospital at St. George's University School of Medicine Oakland California United States 94602
8 Alta Bates Summit Medical Center - Summit Campus Oakland California United States 94609
9 CCOP - Bay Area Tumor Institute Oakland California United States 94609
10 Valley Care Medical Center Pleasanton California United States 94588
11 Doctors Medical Center - San Pablo Campus San Pablo California United States 94806
12 West Florida Cancer Institute at West Florida Hospital - Pensacola Pensacola Florida United States 32514
13 Northeast Georgia Medical Center Gainesville Georgia United States 30501
14 Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah Georgia United States 31403-3089
15 St. Luke's Mountain States Tumor Institute - Boise Boise Idaho United States 83712
16 Decatur Memorial Hospital Cancer Care Institute Decatur Illinois United States 62526
17 Veterans Affairs Medical Center - Hines Hines Illinois United States 60141
18 Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood Illinois United States 60153
19 Regional Cancer Center at Memorial Medical Center Springfield Illinois United States 62781-0001
20 Genesis Regional Cancer Center at Genesis Medical Center Davenport Iowa United States 52803
21 Tammy Walker Cancer Center at Salina Regional Health Center Salina Kansas United States 67401
22 Stormont-Vail Cancer Center Topeka Kansas United States 66604
23 St. Francis Comprehensive Cancer Center Topeka Kansas United States 66606
24 Wesley Medical Center Wichita Kansas United States 67214
25 Christus Schumpert Cancer Treatment Center Shreveport Louisiana United States 71101
26 Battle Creek Health System Cancer Care Center Battle Creek Michigan United States 49017
27 Mecosta County Medical Center Big Rapids Michigan United States 49307
28 Josephine Ford Cancer Center at Henry Ford Hospital Detroit Michigan United States 48202
29 CCOP - Grand Rapids Grand Rapids Michigan United States 49503
30 Lacks Cancer Center at Saint Mary's Health Care Grand Rapids Michigan United States 49503
31 Spectrum Health Hospital - Butterworth Campus Grand Rapids Michigan United States 49503
32 Metro Health Hospital Grand Rapids Michigan United States 49506
33 Holland Community Hospital Holland Michigan United States 49423
34 Ted B. Wahby Cancer Center at Mount Clemens General Hospital Mount Clemens Michigan United States 48043
35 Hackley Hospital Muskegon Michigan United States 49442
36 Mercy Regional Cancer Center at Mercy Hospital Port Huron Michigan United States 48060
37 Munson Medical Center Traverse City Michigan United States 49684
38 Freeman Cancer Institute at Freeman Health System Joplin Missouri United States 64804
39 CCOP - Kansas City Kansas City Missouri United States 64131
40 CCOP - Cancer Research for the Ozarks Springfield Missouri United States 65802
41 St. John's Regional Health Center Springfield Missouri United States 65804
42 Hulston Cancer Center at Cox Medical Center South Springfield Missouri United States 65807
43 CCOP - Montana Cancer Consortium Billings Montana United States 59101
44 Hematology-Oncology Centers of the Northern Rockies - Billings Billings Montana United States 59101
45 Northern Rockies Radiation Oncology Center Billings Montana United States 59101
46 St. Vincent Healthcare Billings Montana United States 59101
47 Billings Clinic Cancer Center Billings Montana United States 59107-5100
48 Deaconess Billings Clinic - Downtown Billings Montana United States 59107-7000
49 Bozeman Deaconess Hospital Bozeman Montana United States 59715
50 St. James Community Hospital Butte Montana United States 59701
51 Big Sky Oncology Great Falls Montana United States 59405
52 Sletten Regional Cancer Institute at Benefis Healthcare Great Falls Montana United States 59405
53 Great Falls Montana United States 59405
54 St. Peter's Hospital Helena Montana United States 59601
55 Glacier Oncology, PLLC Kalispell Montana United States 59901
56 Kalispell Medical Oncology Kalispell Montana United States 59901
57 Kalispell Regional Medical Center Kalispell Montana United States 59901
58 Community Medical Center Missoula Montana United States 59801
59 Guardian Oncology and Center for Wellness Missoula Montana United States 59804
60 Montana Cancer Specialists at Montana Cancer Center Missoula Montana United States 59807-7877
61 Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula Montana United States 59807
62 Good Samaritan Cancer Center at Good Samaritan Hospital Kearney Nebraska United States 68848-1990
63 Tucker Center for Cancer Care at Orange Regional Medical Center Middletown New York United States 10940-4199
64 Highland Hospital of Rochester Rochester New York United States 14620
65 Interlakes Oncology/Hematology PC Rochester New York United States 14623
66 James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester New York United States 14642
67 CaroMont Cancer Center at Gaston Memorial Hospital Gastonia North Carolina United States 28053
68 Wayne Memorial Hospital, Incorporated Goldsboro North Carolina United States 27534
69 Wayne Radiation Oncology Goldsboro North Carolina United States 27534
70 Rutherford Hospital Rutherfordton North Carolina United States 28139
71 Wilson Medical Center Wilson North Carolina United States 27893-3428
72 Adena Regional Medical Center Chillicothe Ohio United States 45601
73 Charles M. Barrett Cancer Center at University Hospital Cincinnati Ohio United States 45267
74 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
75 Riverside Methodist Hospital Cancer Care Columbus Ohio United States 43214-3998
76 CCOP - Columbus Columbus Ohio United States 43215
77 Grant Riverside Cancer Services Columbus Ohio United States 43215
78 Mount Carmel Health - West Hospital Columbus Ohio United States 43222
79 Doctors Hospital at Ohio Health Columbus Ohio United States 43228
80 Grady Memorial Hospital Delaware Ohio United States 43015
81 Community Oncology Group at Cleveland Clinic Cancer Center Independence Ohio United States 44131
82 Fairfield Medical Center Lancaster Ohio United States 43130
83 Strecker Cancer Center at Marietta Memorial Hospital Marietta Ohio United States 45750
84 Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark Ohio United States 43055
85 Mercy Medical Center Springfield Ohio United States 45504
86 Community Hospital of Springfield and Clark County Springfield Ohio United States 45505
87 Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital Westerville Ohio United States 43081
88 Cleveland Clinic - Wooster Wooster Ohio United States 44691
89 Tod Children's Hospital - Forum Health Youngstown Ohio United States 44501
90 Genesis - Good Samaritan Hospital Zanesville Ohio United States 43701
91 Legacy Mount Hood Medical Center Gresham Oregon United States 97030
92 Providence Milwaukie Hospital Milwaukie Oregon United States 97222
93 Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center Portland Oregon United States 97210
94 Providence Cancer Center at Providence Portland Medical Center Portland Oregon United States 97213-2967
95 CCOP - Columbia River Oncology Program Portland Oregon United States 97225
96 Providence St. Vincent Medical Center Portland Oregon United States 97225
97 Legacy Emanuel Hospital and Health Center & Children's Hospital Portland Oregon United States 97227
98 Legacy Meridian Park Hospital Tualatin Oregon United States 97062
99 AnMed Health Cancer Center Anderson South Carolina United States 29621
100 Roper St. Francis Cancer Center at Roper Hospital Charleston South Carolina United States 29401
101 CCOP - Upstate Carolina Spartanburg South Carolina United States 29303
102 Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg South Carolina United States 29303
103 U.T. Cancer Institute at University of Tennessee Medical Center Knoxville Tennessee United States 37920-6999
104 Medical City Dallas Hospital Dallas Texas United States 75230
105 Brooke Army Medical Center Fort Sam Houston Texas United States 78234
106 Wilford Hall Medical Center Lackland AFB Texas United States 78236
107 CCOP - Scott and White Hospital Temple Texas United States 76508
108 American Fork Hospital American Fork Utah United States 84003
109 Logan Regional Hospital Logan Utah United States 84321
110 Cottonwood Hospital Medical Center Murray Utah United States 84107
111 McKay-Dee Hospital Center Ogden Utah United States 84403
112 Utah Valley Regional Medical Center - Provo Provo Utah United States 84604
113 Dixie Regional Medical Center - East Campus Saint George Utah United States 84770
114 Latter Day Saints Hospital Salt Lake City Utah United States 84103
115 Utah Cancer Specialists at UCS Cancer Center Salt Lake City Utah United States 84106
116 Danville Regional Medical Center Danville Virginia United States 24541
117 St. Joseph Cancer Center Bellingham Washington United States 98225
118 Olympic Hematology and Oncology Bremerton Washington United States 98310
119 Skagit Valley Hospital Cancer Care Center Mt. Vernon Washington United States 98273
120 Fred Hutchinson Cancer Research Center Seattle Washington United States 98104
121 Harborview Medical Center Seattle Washington United States 98104
122 Minor and James Medical, PLLC Seattle Washington United States 98104
123 Group Health Central Hospital Seattle Washington United States 98112
124 Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle Washington United States 98122-4307
125 Polyclinic First Hill Seattle Washington United States 98122
126 University Cancer Center at University of Washington Medical Center Seattle Washington United States 98195-6043
127 North Puget Oncology at United General Hospital Sedro-Wooley Washington United States 98284
128 Cancer Care Northwest - Spokane South Spokane Washington United States 99202
129 Southwest Washington Medical Center Cancer Center Vancouver Washington United States 98668
130 Wenatchee Valley Medical Center Wenatchee Washington United States 98801-2028
131 Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital Parkersburg West Virginia United States 26102
132 Welch Cancer Center at Sheridan Memorial Hospital Sheridan Wyoming United States 82801

Sponsors and Collaborators

  • Southwest Oncology Group
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Joseph I. Clark, MD, Loyola University
  • Principal Investigator: Laura F. Hutchins, MD, University of Arkansas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00104988
Other Study ID Numbers:
  • CDR0000412048
  • S0508
  • U10CA032102
First Posted:
Mar 4, 2005
Last Update Posted:
Aug 22, 2012
Last Verified:
Aug 1, 2012
Keywords provided by Southwest Oncology Group
stage IV melanoma
Additional relevant MeSH terms:
Melanoma
Thalidomide
Temozolomide

Study Results

No Results Posted as of Aug 22, 2012