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A Phase II Trial of Combination Thalidomide Plus Temozolomide in Patients With Metastatic Malignant Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma (Skin)

Thank you

Trial Information

A Phase II Trial of Combination Thalidomide Plus Temozolomide in Patients With Metastatic Malignant Melanoma


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 6 months

Outcome Time Frame:

6 months after registration

Safety Issue:

No

Principal Investigator

Joseph I. Clark, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Loyola University

Authority:

United States: Federal Government

Study ID:

CDR0000412048

NCT ID:

NCT00104988

Start Date:

June 2005

Completion Date:

August 2009

Related Keywords:

  • Melanoma (Skin)
  • stage IV melanoma
  • Melanoma

Name

Location

Fred Hutchinson Cancer Research Center Seattle, Washington  98109
Cardinal Bernardin Cancer Center at Loyola University Medical Center Maywood, Illinois  60153-5500
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
Medical City Dallas Hospital Dallas, Texas  75230
CCOP - Kansas City Kansas City, Missouri  64131
CCOP - Bay Area Tumor Institute Oakland, California  94609-3305
CCOP - Cancer Research for the Ozarks Springfield, Missouri  65807
CCOP - Montana Cancer Consortium Billings, Montana  59101
CCOP - Columbus Columbus, Ohio  43206
CCOP - Grand Rapids Grand Rapids, Michigan  49503
Charles M. Barrett Cancer Center at University Hospital Cincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology Program Portland, Oregon  97225
CCOP - Scott and White Hospital Temple, Texas  76508
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and Hospital Los Angeles, California  90033-0804
Brooke Army Medical Center Fort Sam Houston, Texas  78234-6200
Utah Valley Regional Medical Center - Provo Provo, Utah  84604
Wesley Medical Center Wichita, Kansas  67214
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Josephine Ford Cancer Center at Henry Ford Hospital Detroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus Seattle, Washington  98104
Hulston Cancer Center at Cox Medical Center South Springfield, Missouri  65807
St. John's Regional Health Center Springfield, Missouri  65804
Wilford Hall Medical Center Lackland Air Force Base, Texas  78236-5300
Latter Day Saints Hospital Salt Lake City, Utah  84143
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center Savannah, Georgia  31403-3089
St. Luke's Mountain States Tumor Institute - Boise Boise, Idaho  83712-6297
Tod Children's Hospital - Forum Health Youngstown, Ohio  44501
Legacy Emanuel Hospital and Health Center & Children's Hospital Portland, Oregon  97227
Interlakes Oncology/Hematology PC Rochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical Center Rochester, New York  14642
Alaska Regional Hospital Cancer Center Anchorage, Alaska  99508
Battle Creek Health System Cancer Care Center Battle Creek, Michigan  49017
Holland Community Hospital Holland, Michigan  49423
Hackley Hospital Muskegon, Michigan  49443
Munson Medical Center Traverse City, Michigan  49684
Northern Rockies Radiation Oncology Center Billings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - Billings Billings, Montana  59101
St. Vincent Healthcare Billings, Montana  59101
Deaconess Billings Clinic - Downtown Billings, Montana  59101
Bozeman Deaconess Hospital Bozeman, Montana  59715
St. James Community Hospital Butte, Montana  59701
Big Sky Oncology Great Falls, Montana  59405
St. Peter's Hospital Helena, Montana  59601
Kalispell Medical Oncology Kalispell, Montana  59901
Kalispell Regional Medical Center Kalispell, Montana  59901
Glacier Oncology, PLLC Kalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center Missoula, Montana  59802
Montana Cancer Specialists at Montana Cancer Center Missoula, Montana  59802
Community Medical Center Missoula, Montana  59801
Wayne Memorial Hospital, Incorporated Goldsboro, North Carolina  27534
Adena Regional Medical Center Chillicothe, Ohio  54601
Doctors Hospital at Ohio Health Columbus, Ohio  43228
Riverside Methodist Hospital Cancer Care Columbus, Ohio  43214
Grant Riverside Cancer Services Columbus, Ohio  43215
Grady Memorial Hospital Delaware, Ohio  43015
Fairfield Medical Center Lancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial Hospital Marietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial Hospital Newark, Ohio  43055
Community Hospital of Springfield and Clark County Springfield, Ohio  45505
Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital Westerville, Ohio  43081
Genesis - Good Samaritan Hospital Zanesville, Ohio  43701
American Fork Hospital American Fork, Utah  84003
Logan Regional Hospital Logan, Utah  84321
Cottonwood Hospital Medical Center Murray, Utah  84107
McKay-Dee Hospital Center Ogden, Utah  84403
Utah Cancer Specialists at UCS Cancer Center Salt Lake City, Utah  84106
Olympic Hematology and Oncology Bremerton, Washington  98310
Skagit Valley Hospital Cancer Care Center Mt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical Center Seattle, Washington  98195
Harborview Medical Center Seattle, Washington  98104
Group Health Central Hospital Seattle, Washington  98104
North Puget Oncology at United General Hospital Sedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane South Spokane, Washington  99202
Veterans Affairs Medical Center - Hines Hines, Illinois  60141
Spectrum Health Hospital - Butterworth Campus Grand Rapids, Michigan  49503
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Mount Carmel Health - West Hospital Columbus, Ohio  43222
Eden Medical Center Castro Valley, California  94546
North Bay Cancer Center Fairfield, California  94533
Saint Rose Hospital Hayward, California  94545
Highland General Hospital at St. George's University School of Medicine Oakland, California  94602
Alta Bates Summit Medical Center - Summit Campus Oakland, California  94609
Valley Care Medical Center Pleasanton, California  94588
Genesis Regional Cancer Center at Genesis Medical Center Davenport, Iowa  52803
Stormont-Vail Cancer Center Topeka, Kansas  66604
St. Francis Comprehensive Cancer Center Topeka, Kansas  66606
Mecosta County Medical Center Big Rapids, Michigan  49307
Highland Hospital of Rochester Rochester, New York  14620
Wayne Radiation Oncology Goldsboro, North Carolina  27534
Wilson Medical Center Wilson, North Carolina  27893-3428
Community Oncology Group at Cleveland Clinic Cancer Center Independence, Ohio  44131
Mercy Medical Center Springfield, Ohio  45504
Cleveland Clinic - Wooster Wooster, Ohio  44691
Legacy Mount Hood Medical Center Gresham, Oregon  97030
Providence Milwaukie Hospital Milwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center Portland, Oregon  97210
Providence Cancer Center at Providence Portland Medical Center Portland, Oregon  97213-2967
Providence St. Vincent Medical Center Portland, Oregon  97225
Legacy Meridian Park Hospital Tualatin, Oregon  97062
Dixie Regional Medical Center - East Campus Saint George, Utah  84770
Danville Regional Medical Center Danville, Virginia  24541
Minor and James Medical, PLLC Seattle, Washington  98104
Polyclinic First Hill Seattle, Washington  98122
Southwest Washington Medical Center Cancer Center Vancouver, Washington  98668
Welch Cancer Center at Sheridan Memorial Hospital Sheridan, Wyoming  82801
Northeast Georgia Medical Center Gainesville, Georgia  30501
West Florida Cancer Institute at West Florida Hospital - Pensacola Pensacola, Florida  32514
Tammy Walker Cancer Center at Salina Regional Health Center Salina, Kansas  67401
Mercy Regional Cancer Center at Mercy Hospital Port Huron, Michigan  48060
St. Joseph Cancer Center Bellingham, Washington  98225
Wenatchee Valley Medical Center Wenatchee, Washington  98801-2028
Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital Parkersburg, West Virginia  26102
Regional Cancer Center at Memorial Medical Center Springfield, Illinois  62781-0001
Good Samaritan Cancer Center at Good Samaritan Hospital Kearney, Nebraska  68848-1990
Tucker Center for Cancer Care at Orange Regional Medical Center Middletown, New York  10940-4199
Rutherford Hospital Rutherfordton, North Carolina  28139
AnMed Health Cancer Center Anderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center Spartanburg, South Carolina  29303
Freeman Cancer Institute at Freeman Health System Joplin, Missouri  64803-2644
U.T. Cancer Institute at University of Tennessee Medical Center Knoxville, Tennessee  37920-2911
Lacks Cancer Center at Saint Mary's Health Care Grand Rapids, Michigan  49503
Metro Health Hospital Grand Rapids, Michigan  49506
Billings Clinic Cancer Center Billings, Montana  59107-5100
Great Falls, Montana  59405
Sletten Regional Cancer Institute at Benefis Healthcare Great Falls, Montana  59405
Guardian Oncology and Center for Wellness Missoula, Montana  59804
Roper St. Francis Cancer Center at Roper Hospital Charleston, South Carolina  29401
Doctors Medical Center - San Pablo Campus San Pablo, California  94806
Ted B. Wahby Cancer Center at Mount Clemens General Hospital Mount Clemens, Michigan  48043
Christus Schumpert Cancer Treatment Center Shreveport, Louisiana  71101
CaroMont Cancer Center at Gaston Memorial Hospital Gastonia, North Carolina  28053