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

NCT00104988 | Completed Phase 2 DMC

• 3 other identifiers: CDR0000412048S0508U10CA032102
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 132

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.

Conditions

Melanoma (Skin)

Keywords

stage IV melanoma

Outcome Measures

Primary Outcomes (3)

• Progression-free survival at 6 months

  6 months after registration

• Objective response (confirmed and unconfirmed complete and partial responses)

  Week 9, every 8 weeks thereafter until progression

• 6-month overall survival

  six months after registration

Study Arms (1)

Thalidomide and Temozolomide

EXPERIMENTAL

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; Drug: thalidomide

Interventions

temozolomide DRUG

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

Thalidomide and Temozolomide

thalidomide DRUG

200 mg/day PO daily

Thalidomide and Temozolomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (132)

Alaska Regional Hospital Cancer Center

Anchorage, Alaska, 99508, United States

Location

Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

Eden Medical Center

Castro Valley, California, 94546, United States

Location

North Bay Cancer Center

Fairfield, California, 94533, United States

Location

Saint Rose Hospital

Hayward, California, 94545, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Highland General Hospital at St. George's University School of Medicine

Oakland, California, 94602, United States

Location

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, 94609, United States

Location

CCOP - Bay Area Tumor Institute

Oakland, California, 94609, United States

Location

Valley Care Medical Center

Pleasanton, California, 94588, United States

Location

Doctors Medical Center - San Pablo Campus

San Pablo, California, 94806, United States

Location

West Florida Cancer Institute at West Florida Hospital - Pensacola

Pensacola, Florida, 32514, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31403-3089, United States

Location

St. Luke's Mountain States Tumor Institute - Boise

Boise, Idaho, 83712, United States

Location

Decatur Memorial Hospital Cancer Care Institute

Decatur, Illinois, 62526, United States

Location

Veterans Affairs Medical Center - Hines

Hines, Illinois, 60141, United States

Location

Cardinal Bernardin Cancer Center at Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Regional Cancer Center at Memorial Medical Center

Springfield, Illinois, 62781-0001, United States

Location

Genesis Regional Cancer Center at Genesis Medical Center

Davenport, Iowa, 52803, United States

Location

Tammy Walker Cancer Center at Salina Regional Health Center

Salina, Kansas, 67401, United States

Location

Stormont-Vail Cancer Center

Topeka, Kansas, 66604, United States

Location

St. Francis Comprehensive Cancer Center

Topeka, Kansas, 66606, United States

Location

Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

Christus Schumpert Cancer Treatment Center

Shreveport, Louisiana, 71101, United States

Location

Battle Creek Health System Cancer Care Center

Battle Creek, Michigan, 49017, United States

Location

Mecosta County Medical Center

Big Rapids, Michigan, 49307, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

CCOP - Grand Rapids

Grand Rapids, Michigan, 49503, United States

Location

Lacks Cancer Center at Saint Mary's Health Care

Grand Rapids, Michigan, 49503, United States

Location

Spectrum Health Hospital - Butterworth Campus

Grand Rapids, Michigan, 49503, United States

Location

Metro Health Hospital

Grand Rapids, Michigan, 49506, United States

Location

Holland Community Hospital

Holland, Michigan, 49423, United States

Location

Ted B. Wahby Cancer Center at Mount Clemens General Hospital

Mount Clemens, Michigan, 48043, United States

Location

Hackley Hospital

Muskegon, Michigan, 49442, United States

Location

Mercy Regional Cancer Center at Mercy Hospital

Port Huron, Michigan, 48060, United States

Location

Munson Medical Center

Traverse City, Michigan, 49684, United States

Location

Freeman Cancer Institute at Freeman Health System

Joplin, Missouri, 64804, United States

Location

CCOP - Kansas City

Kansas City, Missouri, 64131, United States

Location

CCOP - Cancer Research for the Ozarks

Springfield, Missouri, 65802, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

CCOP - Montana Cancer Consortium

Billings, Montana, 59101, United States

Location

Hematology-Oncology Centers of the Northern Rockies - Billings

Billings, Montana, 59101, United States

Location

Northern Rockies Radiation Oncology Center

Billings, Montana, 59101, United States

Location

St. Vincent Healthcare

Billings, Montana, 59101, United States

Location

Billings Clinic Cancer Center

Billings, Montana, 59107-5100, United States

Location

Deaconess Billings Clinic - Downtown

Billings, Montana, 59107-7000, United States

Location

Bozeman Deaconess Hospital

Bozeman, Montana, 59715, United States

Location

St. James Community Hospital

Butte, Montana, 59701, United States

Location

Big Sky Oncology

Great Falls, Montana, 59405, United States

Location

Sletten Regional Cancer Institute at Benefis Healthcare

Great Falls, Montana, 59405, United States

Location

Unknown Facility

Great Falls, Montana, 59405, United States

Location

St. Peter's Hospital

Helena, Montana, 59601, United States

Location

Glacier Oncology, PLLC

Kalispell, Montana, 59901, United States

Location

Kalispell Medical Oncology

Kalispell, Montana, 59901, United States

Location

Kalispell Regional Medical Center

Kalispell, Montana, 59901, United States

Location

Community Medical Center

Missoula, Montana, 59801, United States

Location

Guardian Oncology and Center for Wellness

Missoula, Montana, 59804, United States

Location

Montana Cancer Specialists at Montana Cancer Center

Missoula, Montana, 59807-7877, United States

Location

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

Missoula, Montana, 59807, United States

Location

Good Samaritan Cancer Center at Good Samaritan Hospital

Kearney, Nebraska, 68848-1990, United States

Location

Tucker Center for Cancer Care at Orange Regional Medical Center

Middletown, New York, 10940-4199, United States

Location

Highland Hospital of Rochester

Rochester, New York, 14620, United States

Location

Interlakes Oncology/Hematology PC

Rochester, New York, 14623, United States

Location

James P. Wilmot Cancer Center at University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

CaroMont Cancer Center at Gaston Memorial Hospital

Gastonia, North Carolina, 28053, United States

Location

Wayne Memorial Hospital, Incorporated

Goldsboro, North Carolina, 27534, United States

Location

Wayne Radiation Oncology

Goldsboro, North Carolina, 27534, United States

Location

Rutherford Hospital

Rutherfordton, North Carolina, 28139, United States

Location

Wilson Medical Center

Wilson, North Carolina, 27893-3428, United States

Location

Adena Regional Medical Center

Chillicothe, Ohio, 45601, United States

Location

Charles M. Barrett Cancer Center at University Hospital

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214-3998, United States

Location

CCOP - Columbus

Columbus, Ohio, 43215, United States

Location

Grant Riverside Cancer Services

Columbus, Ohio, 43215, United States

Location

Mount Carmel Health - West Hospital

Columbus, Ohio, 43222, United States

Location

Doctors Hospital at Ohio Health

Columbus, Ohio, 43228, United States

Location

Grady Memorial Hospital

Delaware, Ohio, 43015, United States

Location

Community Oncology Group at Cleveland Clinic Cancer Center

Independence, Ohio, 44131, United States

Location

Fairfield Medical Center

Lancaster, Ohio, 43130, United States

Location

Strecker Cancer Center at Marietta Memorial Hospital

Marietta, Ohio, 45750, United States

Location

Licking Memorial Cancer Care Program at Licking Memorial Hospital

Newark, Ohio, 43055, United States

Location

Mercy Medical Center

Springfield, Ohio, 45504, United States

Location

Community Hospital of Springfield and Clark County

Springfield, Ohio, 45505, United States

Location

Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital

Westerville, Ohio, 43081, United States

Location

Cleveland Clinic - Wooster

Wooster, Ohio, 44691, United States

Location

Tod Children's Hospital - Forum Health

Youngstown, Ohio, 44501, United States

Location

Genesis - Good Samaritan Hospital

Zanesville, Ohio, 43701, United States

Location

Legacy Mount Hood Medical Center

Gresham, Oregon, 97030, United States

Location

Providence Milwaukie Hospital

Milwaukie, Oregon, 97222, United States

Location

Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

Portland, Oregon, 97210, United States

Location

Providence Cancer Center at Providence Portland Medical Center

Portland, Oregon, 97213-2967, United States

Location

CCOP - Columbia River Oncology Program

Portland, Oregon, 97225, United States

Location

Providence St. Vincent Medical Center

Portland, Oregon, 97225, United States

Location

Legacy Emanuel Hospital and Health Center & Children's Hospital

Portland, Oregon, 97227, United States

Location

Legacy Meridian Park Hospital

Tualatin, Oregon, 97062, United States

Location

AnMed Health Cancer Center

Anderson, South Carolina, 29621, United States

Location

Roper St. Francis Cancer Center at Roper Hospital

Charleston, South Carolina, 29401, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

U.T. Cancer Institute at University of Tennessee Medical Center

Knoxville, Tennessee, 37920-6999, United States

Location

Medical City Dallas Hospital

Dallas, Texas, 75230, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Wilford Hall Medical Center

Lackland Air Force Base, Texas, 78236, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

American Fork Hospital

American Fork, Utah, 84003, United States

Location

Logan Regional Hospital

Logan, Utah, 84321, United States

Location

Cottonwood Hospital Medical Center

Murray, Utah, 84107, United States

Location

McKay-Dee Hospital Center

Ogden, Utah, 84403, United States

Location

Utah Valley Regional Medical Center - Provo

Provo, Utah, 84604, United States

Location

Latter Day Saints Hospital

Salt Lake City, Utah, 84103, United States

Location

Utah Cancer Specialists at UCS Cancer Center

Salt Lake City, Utah, 84106, United States

Location

Dixie Regional Medical Center - East Campus

St. George, Utah, 84770, United States

Location

Danville Regional Medical Center

Danville, Virginia, 24541, United States

Location

St. Joseph Cancer Center

Bellingham, Washington, 98225, United States

Location

Olympic Hematology and Oncology

Bremerton, Washington, 98310, United States

Location

Skagit Valley Hospital Cancer Care Center

Mount Vernon, Washington, 98273, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98104, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Minor and James Medical, PLLC

Seattle, Washington, 98104, United States

Location

Group Health Central Hospital

Seattle, Washington, 98112, United States

Location

Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

Seattle, Washington, 98122-4307, United States

Location

Polyclinic First Hill

Seattle, Washington, 98122, United States

Location

University Cancer Center at University of Washington Medical Center

Seattle, Washington, 98195-6043, United States

Location

North Puget Oncology at United General Hospital

Sedro-Woolley, Washington, 98284, United States

Location

Cancer Care Northwest - Spokane South

Spokane, Washington, 99202, United States

Location

Southwest Washington Medical Center Cancer Center

Vancouver, Washington, 98668, United States

Location

Wenatchee Valley Medical Center

Wenatchee, Washington, 98801-2028, United States

Location

Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital

Parkersburg, West Virginia, 26102, United States

Location

Welch Cancer Center at Sheridan Memorial Hospital

Sheridan, Wyoming, 82801, United States

Location

Related Publications (1)

• Clark JI, Moon J, Hutchins LF, Sosman JA, Kast WM, Da Silva DM, Liu PY, Thompson JA, Flaherty LE, Sondak VK. Phase 2 trial of combination thalidomide plus temozolomide in patients with metastatic malignant melanoma: Southwest Oncology Group S0508. Cancer. 2010 Jan 15;116(2):424-31. doi: 10.1002/cncr.24739.

  PMID: 19918923 RESULT

MeSH Terms

Conditions

Melanoma

Interventions

Temozolomide; Thalidomide

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Joseph I. Clark, MD

  Loyola University

  STUDY CHAIR

• Laura F. Hutchins, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2005
• First Posted: March 4, 2005
• Study Start: June 1, 2005
• Primary Completion: July 1, 2007
• Study Completion: August 1, 2009
• Last Updated: August 22, 2012

Record last verified: 2012-08

Locations

US (132)