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RATIONALE: Thalidomide combined with SU5416 may stop the growth of metastatic melanoma by stopping blood flow to the tumor.
- Determine the efficacy of thalidomide and SU5416 in patients with metastatic melanoma.
- Determine the quantitative and qualitative toxic effects of this regimen in these patients.
- Evaluate the pharmacokinetics of this regimen in these patients.
- Determine the complete and partial responses and response duration in patients treated with this regimen.
- Assess disease-free survival at 6 months of patients treated with this regimen.
OUTLINE: Patients receive SU5416 IV over 1 hour twice weekly and oral thalidomide daily beginning 1 day after the first dose of SU5416. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study.
Primary Purpose: Treatment
University of Texas Health Science Center at San Antonio
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:56:53-0400
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The purpose of this clinical trial is to assess the activity of thalidomide in combination with dacarbazine (DTIC) in patients with metastatic melanoma. Safety and toxicity of the two dru...
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An accurate and sensitive LC-MS/MS method for determining thalidomide, 5-hydroxy thalidomide and 5'-hydroxy thalidomide in human plasma was developed and validated using umbelliferone as an internal s...
Vitiligo is a chronic disorder causing skin depigmentation with around 1% global prevalence, affecting people of all ages, skin types and genders. Due to the absence of melanin in lesional skin there ...
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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)
A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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.
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.
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)
Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.
Bladder Cancer Brain Cancer Breast Cancer Cancer Cervical Cancer Colorectal Head & Neck Cancers Hodgkin Lymphoma Leukemia Lung Cancer Melanoma Myeloma Ovarian Cancer Pancreatic Cancer ...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
Melanoma is a highly malignant tumor of melanin-forming cells (melanocytes) There are most commonly found in the skin (resulting from sunlight exposure), but also in the eyes and mucous membranes. Metastasis to other regions of the body is also common....