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Thalidomide and SU5416 in Treating Patients With Metastatic Melanoma

2014-08-27 03:56:53 | BioPortfolio

Summary

RATIONALE: Thalidomide combined with SU5416 may stop the growth of metastatic melanoma by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of combining thalidomide and SU5416 in treating patients who have metastatic melanoma.

Description

OBJECTIVES:

- 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.

Study Design

Primary Purpose: Treatment

Conditions

Melanoma (Skin)

Intervention

semaxanib, thalidomide

Location

University of Texas Health Science Center at San Antonio
San Antonio
Texas
United States
78284-7811

Status

Completed

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:56:53-0400

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PubMed Articles [3827 Associated PubMed Articles listed on BioPortfolio]

A validated LC-MS/MS method for the simultaneous determination of thalidomide and its two metabolites in human plasma: Application to a pharmacokinetic assay.

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Medical and Biotech [MESH] Definitions

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A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects.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.

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