Temozolomide and Thalidomide in Treating Patients With Brain Metastases Secondary to Melanoma
Summary
RATIONALE: Drugs used in chemotherapy, such as temozolomide, work in 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 with thalidomide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving temozolomide together with thalidomide works in treating patients with brain metastases secondary to melanoma.
Description
OBJECTIVES:
Primary
- Determine the objective response rate in patients with brain metastases secondary to melanoma treated with temozolomide and thalidomide.
Secondary
- Determine the toxic effects of and tolerance to this regimen in these patients.
- Determine the objective response rate in extracranial metastases of patients treated with this regimen.
- Determine the time to first disease progression (intra- or extracranial) in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive oral temozolomide once daily on days 1-42 and oral thalidomide once daily on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses of therapy beyond CR.
Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually for up to 2 years.
PROJECTED ACCRUAL: A total of 21-50 patients will be accrued for this study within 1.5 years.
Study Design
Masking: Open Label, Primary Purpose: Treatment
Conditions
Melanoma (Skin)
Intervention
temozolomide, thalidomide
Location
Northeast Alabama Regional Medical Center
Anniston
Alabama
United States
36207
Status
Completed
Source
National Cancer Institute (NCI)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00072163
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Melanoma, Amelanotic
An unpigmented malignant melanoma. It is an anaplastic melanoma consisting of cells derived from melanoblasts but not forming melanin. (Dorland, 27th ed; Stedman, 25th ed)
Hutchinson's Melanotic Freckle
A cellular subtype of malignant melanoma. It is a pigmented lesion composed of melanocytes occurring on sun-exposed skin, usually the face and neck. The melanocytes are commonly multinucleated with a "starburst" appearance. It is considered by many to be the in situ phase of lentigo maligna melanoma.
Thalidomide
A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppresive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.
Head And Neck Neoplasms
Soft tissue tumors or cancer arising from the mucosal surfaces of the LIP; oral cavity; PHARYNX; LARYNX; and cervical esophagus. Other sites included are the NOSE and PARANASAL SINUSES; SALIVARY GLANDS; THYROID GLAND and PARATHYROID GLANDS; and MELANOMA and non-melanoma skin cancers of the head and neck. (from Holland et al., Cancer Medicine, 4th ed, p1651)
Melanoma, Experimental
Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.
Clinical Trials
Temozolomide and Thalidomide in Treating Patients With Stage III or Stage IV Melanoma
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Temozolomide, Thalidomide, and Lomustine (TTL) in Melanoma Patients
The goal of this clinical research study is to find the highest safe dose of lomustine (CCNU, CeeNU) that can be given with temozolomide (Temodar) and thalidomide (Thalomid) in the treatme...
Biochemotherapy With Temozolomide for Metastatic Melanoma
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Thalidomide and SU5416 in Treating Patients With Metastatic Melanoma
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