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Melanoma (Skin)Phase 2NCT00104988

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

A Phase 2 study testing temozolomide and thalidomide in people with Melanoma (Skin), run by SWOG Cancer Research Network at 132 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin)
What is being tested?
temozolomide and thalidomide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
132 sitesUnited States
Study dates
Jun 2005to Aug 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

132 sites in 1 country.

132 sites in 1 country

United States132 sites

  • American Fork Hospital

    American Fork, Utah, 84003

  • Alaska Regional Hospital Cancer Center

    Anchorage, Alaska, 99508

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Battle Creek Health System Cancer Care Center

    Battle Creek, Michigan, 49017

  • St. Joseph Cancer Center

    Bellingham, Washington, 98225

  • Mecosta County Medical Center

    Big Rapids, Michigan, 49307

  • CCOP - Montana Cancer Consortium

    Billings, Montana, 59101

  • Hematology-Oncology Centers of the Northern Rockies - Billings

    Billings, Montana, 59101

  • Northern Rockies Radiation Oncology Center

    Billings, Montana, 59101

  • St. Vincent Healthcare

    Billings, Montana, 59101

  • Billings Clinic Cancer Center

    Billings, Montana, 59107-5100

  • Deaconess Billings Clinic - Downtown

    Billings, Montana, 59107-7000

  • St. Luke's Mountain States Tumor Institute - Boise

    Boise, Idaho, 83712

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Olympic Hematology and Oncology

    Bremerton, Washington, 98310

  • St. James Community Hospital

    Butte, Montana, 59701

  • Eden Medical Center

    Castro Valley, California, 94546

  • Roper St. Francis Cancer Center at Roper Hospital

    Charleston, South Carolina, 29401

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Charles M. Barrett Cancer Center at University Hospital

    Cincinnati, Ohio, 45267

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Riverside Methodist Hospital Cancer Care

    Columbus, Ohio, 43214-3998

  • CCOP - Columbus

    Columbus, Ohio, 43215

  • Grant Riverside Cancer Services

    Columbus, Ohio, 43215

  • Mount Carmel Health - West Hospital

    Columbus, Ohio, 43222

  • Doctors Hospital at Ohio Health

    Columbus, Ohio, 43228

  • Medical City Dallas Hospital

    Dallas, Texas, 75230

  • Danville Regional Medical Center

    Danville, Virginia, 24541

  • Genesis Regional Cancer Center at Genesis Medical Center

    Davenport, Iowa, 52803

  • Decatur Memorial Hospital Cancer Care Institute

    Decatur, Illinois, 62526

  • Grady Memorial Hospital

    Delaware, Ohio, 43015

  • Josephine Ford Cancer Center at Henry Ford Hospital

    Detroit, Michigan, 48202

  • North Bay Cancer Center

    Fairfield, California, 94533

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • CaroMont Cancer Center at Gaston Memorial Hospital

    Gastonia, North Carolina, 28053

  • Wayne Memorial Hospital, Incorporated

    Goldsboro, North Carolina, 27534

  • Wayne Radiation Oncology

    Goldsboro, North Carolina, 27534

  • CCOP - Grand Rapids

    Grand Rapids, Michigan, 49503

  • Lacks Cancer Center at Saint Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Spectrum Health Hospital - Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Metro Health Hospital

    Grand Rapids, Michigan, 49506

  • Big Sky Oncology

    Great Falls, Montana, 59405

  • Sletten Regional Cancer Institute at Benefis Healthcare

    Great Falls, Montana, 59405

  • Study site

    Great Falls, Montana, 59405

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Saint Rose Hospital

    Hayward, California, 94545

  • St. Peter's Hospital

    Helena, Montana, 59601

  • Veterans Affairs Medical Center - Hines

    Hines, Illinois, 60141

  • Holland Community Hospital

    Holland, Michigan, 49423

  • Community Oncology Group at Cleveland Clinic Cancer Center

    Independence, Ohio, 44131

  • Freeman Cancer Institute at Freeman Health System

    Joplin, Missouri, 64804

  • Glacier Oncology, PLLC

    Kalispell, Montana, 59901

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • CCOP - Kansas City

    Kansas City, Missouri, 64131

  • Good Samaritan Cancer Center at Good Samaritan Hospital

    Kearney, Nebraska, 68848-1990

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

    Knoxville, Tennessee, 37920-6999

  • Wilford Hall Medical Center

    Lackland Air Force Base, Texas, 78236

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Arkansas Cancer Research Center at University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Logan Regional Hospital

    Logan, Utah, 84321

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90089-9181

  • Strecker Cancer Center at Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Cardinal Bernardin Cancer Center at Loyola University Medical Center

    Maywood, Illinois, 60153

  • Tucker Center for Cancer Care at Orange Regional Medical Center

    Middletown, New York, 10940-4199

  • Providence Milwaukie Hospital

    Milwaukie, Oregon, 97222

  • Community Medical Center

    Missoula, Montana, 59801

  • Guardian Oncology and Center for Wellness

    Missoula, Montana, 59804

  • Montana Cancer Specialists at Montana Cancer Center

    Missoula, Montana, 59807-7877

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

    Missoula, Montana, 59807

  • Ted B. Wahby Cancer Center at Mount Clemens General Hospital

    Mount Clemens, Michigan, 48043

  • Skagit Valley Hospital Cancer Care Center

    Mount Vernon, Washington, 98273

  • Cottonwood Hospital Medical Center

    Murray, Utah, 84107

  • Hackley Hospital

    Muskegon, Michigan, 49442

  • Licking Memorial Cancer Care Program at Licking Memorial Hospital

    Newark, Ohio, 43055

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

    Oakland, California, 94602

  • Alta Bates Summit Medical Center - Summit Campus

    Oakland, California, 94609

  • CCOP - Bay Area Tumor Institute

    Oakland, California, 94609

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • Community Comprehensive Cancer Center at Camden-Clark Memorial Hospital

    Parkersburg, West Virginia, 26102

  • West Florida Cancer Institute at West Florida Hospital - Pensacola

    Pensacola, Florida, 32514

  • Valley Care Medical Center

    Pleasanton, California, 94588

  • Mercy Regional Cancer Center at Mercy Hospital

    Port Huron, Michigan, 48060

  • Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

    Portland, Oregon, 97210

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213-2967

  • CCOP - Columbia River Oncology Program

    Portland, Oregon, 97225

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Legacy Emanuel Hospital and Health Center & Children's Hospital

    Portland, Oregon, 97227

  • Utah Valley Regional Medical Center - Provo

    Provo, Utah, 84604

  • Highland Hospital of Rochester

    Rochester, New York, 14620

  • Interlakes Oncology/Hematology PC

    Rochester, New York, 14623

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

    Rochester, New York, 14642

  • Rutherford Hospital

    Rutherfordton, North Carolina, 28139

  • Tammy Walker Cancer Center at Salina Regional Health Center

    Salina, Kansas, 67401

  • Latter Day Saints Hospital

    Salt Lake City, Utah, 84103

  • Utah Cancer Specialists at UCS Cancer Center

    Salt Lake City, Utah, 84106

  • Doctors Medical Center - San Pablo Campus

    San Pablo, California, 94806

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

    Savannah, Georgia, 31403-3089

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98104

  • Harborview Medical Center

    Seattle, Washington, 98104

  • Minor and James Medical, PLLC

    Seattle, Washington, 98104

  • Group Health Central Hospital

    Seattle, Washington, 98112

  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus

    Seattle, Washington, 98122-4307

  • Polyclinic First Hill

    Seattle, Washington, 98122

  • University Cancer Center at University of Washington Medical Center

    Seattle, Washington, 98195-6043

  • North Puget Oncology at United General Hospital

    Sedro-Woolley, Washington, 98284

  • Welch Cancer Center at Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • Christus Schumpert Cancer Treatment Center

    Shreveport, Louisiana, 71101

  • CCOP - Upstate Carolina

    Spartanburg, South Carolina, 29303

  • Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Cancer Care Northwest - Spokane South

    Spokane, Washington, 99202

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • CCOP - Cancer Research for the Ozarks

    Springfield, Missouri, 65802

  • St. John's Regional Health Center

    Springfield, Missouri, 65804

  • Hulston Cancer Center at Cox Medical Center South

    Springfield, Missouri, 65807

  • Mercy Medical Center

    Springfield, Ohio, 45504

  • Community Hospital of Springfield and Clark County

    Springfield, Ohio, 45505

  • Dixie Regional Medical Center - East Campus

    St. George, Utah, 84770

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Stormont-Vail Cancer Center

    Topeka, Kansas, 66604

  • St. Francis Comprehensive Cancer Center

    Topeka, Kansas, 66606

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • Legacy Meridian Park Hospital

    Tualatin, Oregon, 97062

  • Southwest Washington Medical Center Cancer Center

    Vancouver, Washington, 98668

  • Wenatchee Valley Medical Center

    Wenatchee, Washington, 98801-2028

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

    Westerville, Ohio, 43081

  • Wesley Medical Center

    Wichita, Kansas, 67214

  • Wilson Medical Center

    Wilson, North Carolina, 27893-3428

  • Cleveland Clinic - Wooster

    Wooster, Ohio, 44691

  • Tod Children's Hospital - Forum Health

    Youngstown, Ohio, 44501

  • Genesis - Good Samaritan Hospital

    Zanesville, Ohio, 43701

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Melanoma (Skin)
Being tested
temozolomide, thalidomide
Keywords
stage IV melanoma
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • temozolomideDrug

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

  • thalidomideDrug

    200 mg/day PO daily

Study groups in NCT00104988
Study groupRoleWhat they receive
Thalidomide and TemozolomideExperimentalPatients 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.
Receives: Drug: temozolomide; Drug: thalidomide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival at 6 months

    Measured: 6 months after registration

  2. Objective response (confirmed and unconfirmed complete and partial responses)

    Measured: Week 9, every 8 weeks thereafter until progression

  3. 6-month overall survival

    Measured: six months after registration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2005 (estimated)
  2. Study startJun 2005
  3. Primary completionJul 2007
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00104988
Sponsor's protocol ID
CDR0000412048
Other IDs
S0508, U10CA032102
Status last verified
Aug 2012
First submitted
3 Mar 2005
Last updated
22 Aug 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19918923

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing temozolomide and thalidomide in people with Melanoma (Skin), run by SWOG Cancer Research Network at 132 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival at 6 months (time frame: 6 months after registration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00104988, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2012.

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