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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 CenterSeattle, Washington  98109
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Medical City Dallas HospitalDallas, Texas  75230
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
CCOP - ColumbusColumbus, Ohio  43206
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
CCOP - Columbia River Oncology ProgramPortland, Oregon  97225
CCOP - Scott and White HospitalTemple, Texas  76508
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Brooke Army Medical CenterFort Sam Houston, Texas  78234-6200
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Wesley Medical CenterWichita, Kansas  67214
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Swedish Cancer Institute at Swedish Medical Center - First Hill CampusSeattle, Washington  98104
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Latter Day Saints HospitalSalt Lake City, Utah  84143
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
St. Luke's Mountain States Tumor Institute - BoiseBoise, Idaho  83712-6297
Tod Children's Hospital - Forum HealthYoungstown, Ohio  44501
Legacy Emanuel Hospital and Health Center & Children's HospitalPortland, Oregon  97227
Interlakes Oncology/Hematology PCRochester, New York  14623
James P. Wilmot Cancer Center at University of Rochester Medical CenterRochester, New York  14642
Alaska Regional Hospital Cancer CenterAnchorage, Alaska  99508
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
Holland Community HospitalHolland, Michigan  49423
Hackley HospitalMuskegon, Michigan  49443
Munson Medical CenterTraverse City, Michigan  49684
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
Big Sky OncologyGreat Falls, Montana  59405
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grant Riverside Cancer ServicesColumbus, Ohio  43215
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Mount Carmel Cancer Services at Mount Carmel St. Ann's HospitalWesterville, Ohio  43081
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
American Fork HospitalAmerican Fork, Utah  84003
Logan Regional HospitalLogan, Utah  84321
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
Olympic Hematology and OncologyBremerton, Washington  98310
Skagit Valley Hospital Cancer Care CenterMt. Vernon, Washington  98273
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Harborview Medical CenterSeattle, Washington  98104
Group Health Central HospitalSeattle, Washington  98104
North Puget Oncology at United General HospitalSedro-Wooley, Washington  98284
Cancer Care Northwest - Spokane SouthSpokane, Washington  99202
Veterans Affairs Medical Center - HinesHines, Illinois  60141
Spectrum Health Hospital - Butterworth CampusGrand Rapids, Michigan  49503
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Eden Medical CenterCastro Valley, California  94546
North Bay Cancer CenterFairfield, California  94533
Saint Rose HospitalHayward, California  94545
Highland General Hospital at St. George's University School of MedicineOakland, California  94602
Alta Bates Summit Medical Center - Summit CampusOakland, California  94609
Valley Care Medical CenterPleasanton, California  94588
Genesis Regional Cancer Center at Genesis Medical CenterDavenport, Iowa  52803
Stormont-Vail Cancer CenterTopeka, Kansas  66604
St. Francis Comprehensive Cancer CenterTopeka, Kansas  66606
Mecosta County Medical CenterBig Rapids, Michigan  49307
Highland Hospital of RochesterRochester, New York  14620
Wayne Radiation OncologyGoldsboro, North Carolina  27534
Wilson Medical CenterWilson, North Carolina  27893-3428
Community Oncology Group at Cleveland Clinic Cancer CenterIndependence, Ohio  44131
Mercy Medical CenterSpringfield, Ohio  45504
Cleveland Clinic - WoosterWooster, Ohio  44691
Legacy Mount Hood Medical CenterGresham, Oregon  97030
Providence Milwaukie HospitalMilwaukie, Oregon  97222
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer CenterPortland, Oregon  97210
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Providence St. Vincent Medical CenterPortland, Oregon  97225
Legacy Meridian Park HospitalTualatin, Oregon  97062
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Danville Regional Medical CenterDanville, Virginia  24541
Minor and James Medical, PLLCSeattle, Washington  98104
Polyclinic First HillSeattle, Washington  98122
Southwest Washington Medical Center Cancer CenterVancouver, Washington  98668
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Northeast Georgia Medical CenterGainesville, Georgia  30501
West Florida Cancer Institute at West Florida Hospital - PensacolaPensacola, Florida  32514
Tammy Walker Cancer Center at Salina Regional Health CenterSalina, Kansas  67401
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
St. Joseph Cancer CenterBellingham, Washington  98225
Wenatchee Valley Medical CenterWenatchee, Washington  98801-2028
Community Comprehensive Cancer Center at Camden-Clark Memorial HospitalParkersburg, West Virginia  26102
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Tucker Center for Cancer Care at Orange Regional Medical CenterMiddletown, New York  10940-4199
Rutherford HospitalRutherfordton, North Carolina  28139
AnMed Health Cancer CenterAnderson, South Carolina  29621
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Freeman Cancer Institute at Freeman Health SystemJoplin, Missouri  64803-2644
U.T. Cancer Institute at University of Tennessee Medical CenterKnoxville, Tennessee  37920-2911
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Billings Clinic Cancer CenterBillings, Montana  59107-5100
Great Falls, Montana  59405
Sletten Regional Cancer Institute at Benefis HealthcareGreat Falls, Montana  59405
Guardian Oncology and Center for WellnessMissoula, Montana  59804
Roper St. Francis Cancer Center at Roper HospitalCharleston, South Carolina  29401
Doctors Medical Center - San Pablo CampusSan Pablo, California  94806
Ted B. Wahby Cancer Center at Mount Clemens General HospitalMount Clemens, Michigan  48043
Christus Schumpert Cancer Treatment CenterShreveport, Louisiana  71101
CaroMont Cancer Center at Gaston Memorial HospitalGastonia, North Carolina  28053