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

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ClinicalTrials.gov Identifier: NCT00104988
Recruitment Status : Completed
First Posted : March 4, 2005
Last Update Posted : August 22, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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
Melanoma (Skin) Drug: temozolomide Drug: thalidomide Phase 2

Detailed Description:


  • 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
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 : June 2005
Primary Completion Date : July 2007
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Progression-free survival at 6 months [ Time Frame: 6 months after registration ]
  2. Objective response (confirmed and unconfirmed complete and partial responses) [ Time Frame: Week 9, every 8 weeks thereafter until progression ]
  3. 6-month overall survival [ Time Frame: six months after registration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • Zubrod 0-1

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,000/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL (transfusions allowed)


  • Bilirubin ≤ 3 times upper limit of normal (ULN)
  • SGOT or SGPT ≤ 2.5 times ULN (5 times ULN if liver metastases are present)


  • Creatinine ≤ 1.5 times ULN


  • 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


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


  • 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


  • See Disease Characteristics
  • At least 28 days since prior radiotherapy


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


  • No more than 1 prior systemic therapy regimen for stage IV disease
  • At least 28 days since other prior systemic therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00104988

  Show 132 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Joseph I. Clark, MD Loyola University
Principal Investigator: Laura F. Hutchins, MD University of Arkansas

Clark J, Moon J, Hutchins LF, et al.: Phase II trial of combination thalidomide (thal) plus temozolomide (TMZ [TT]), in patients with metastatic malignant melanoma (MMM): Southwest Oncology Group S0508. [Abstract] J Clin Oncol 26 (Suppl 15): A-9007, 2008.

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00104988     History of Changes
Other Study ID Numbers: CDR0000412048
S0508 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: March 4, 2005    Key Record Dates
Last Update Posted: August 22, 2012
Last Verified: August 2012

Keywords provided by Southwest Oncology Group:
stage IV melanoma

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors