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Temozolomide, Thalidomide, and Lomustine in Treating Patients With Unresectable Stage III or Stage IV Melanoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00072345
Recruitment Status : Completed
First Posted : November 6, 2003
Last Update Posted : January 18, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as temozolomide and lomustine, use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining temozolomide and thalidomide with lomustine may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining temozolomide and thalidomide with lomustine in treating patients who have unresectable stage III or stage IV melanoma.

Condition or disease Intervention/treatment Phase
Intraocular Melanoma Melanoma (Skin) Drug: lomustine Drug: temozolomide Drug: thalidomide Phase 2

Detailed Description:



  • Determine the antitumor activity of temozolomide, thalidomide, and lomustine, in terms of objective response rate, in patients with unresectable stage III or stage IV melanoma.


  • Determine the toxicity profile of this regimen in these patients.
  • Determine the duration of response and overall survival of patients treated with this regimen.

OUTLINE: Patients receive oral temozolomide on days 1-42, oral thalidomide on days 1-56, and oral lomustine on days 1 and 29. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 2 years.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Temozolomide, Thalidomide, and Lomustine in the Treatment of Advanced Melanoma
Study Start Date : July 2003
Actual Primary Completion Date : August 2004

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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


  • Histologically confirmed metastatic malignant melanoma

    • Unresectable stage III OR stage IV disease
    • Ocular, mucosal, and cutaneous melanoma allowed
  • Measurable disease

    • Indicator lesions within a prior radiotherapy field must have recent evidence of disease progression
    • Indicator lesions must be distinct from the surgical and/or radiation changes induced by prior local therapies
  • No more than 2 symptomatic hemorrhagic lesions in the brain

    • No hemorrhagic lesion(s) greater than 1 cm in diameter



  • 18 and over

Performance status

  • Karnofsky 80-100%

Life expectancy

  • Not specified


  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • SGOT and SGPT no greater than 2 times ULN
  • Alkaline phosphatase no greater than 2 times ULN
  • Lactic dehydrogenase no greater than 2 times ULN


  • Creatinine no greater than 2 mg/dL


  • No history of severe cardiovascular disease
  • No myocardial infarction within the past 6 months
  • No unstable angina
  • No New York Heart Association class III or IV congestive heart failure
  • No ventricular arrhythmia
  • No uncontrolled arrhythmia


  • No frequent vomiting
  • No other medical condition that would preclude oral medication intake (e.g., partial bowel obstruction)


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier contraception during and for 4 weeks after study participation
  • HIV negative
  • No AIDS-related illness
  • No serious infection requiring IV antibiotics
  • No other uncontrolled medical illness that would preclude study participation
  • No other malignancy within the past 2 years except nonmelanoma skin cancer, carcinoma in situ of the cervix, or T1a or b prostate cancer meeting all of the following criteria:

    • Detected incidentally at transurethral resection of the prostate (TURP)
    • Comprises less than 5% of resected tissue
    • Prostate-specific antigen normal since TURP


Biologic therapy

  • At least 3 weeks since prior immunotherapy or biologic therapy
  • No concurrent immunotherapy


  • No prior systemic chemotherapy for melanoma
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified


  • See Disease Characteristics
  • At least 3 weeks since prior focused radiotherapy for brain metastases
  • At least 3 weeks since prior radiosurgery
  • At least 4 weeks since prior whole brain radiotherapy
  • At least 3 weeks since prior interstitial brachytherapy
  • No concurrent radiotherapy


  • See Disease Characteristics
  • At least 3 weeks since prior surgery for brain metastases
  • At least 3 weeks since prior surgery requiring general anesthesia


  • Recovered from all prior therapies

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 identifier (NCT number): NCT00072345

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United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Wen-Jen Hwu, MD, PhD Memorial Sloan Kettering Cancer Center
Layout table for additonal information Identifier: NCT00072345    
Other Study ID Numbers: 03-084
P30CA008748 ( U.S. NIH Grant/Contract )
First Posted: November 6, 2003    Key Record Dates
Last Update Posted: January 18, 2013
Last Verified: January 2013
Keywords provided by Memorial Sloan Kettering Cancer Center:
stage III melanoma
stage IV melanoma
recurrent melanoma
iris melanoma
ciliary body and choroid melanoma, medium/large size
ciliary body and choroid melanoma, small size
extraocular extension melanoma
recurrent intraocular melanoma
Additional relevant MeSH terms:
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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