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Study of Nilotinib in Metastatic Melanoma With KIT Aberrations

2014-08-27 03:14:45 | BioPortfolio

Summary

Major response was observed to imatinib mesylate in KIT-mutated metastatic rectal melanoma (Hodi FS et al, J Clin Oncol 26:2046-2051, 2008). In the ASCO annual meeting in 2009ar, KIT mutations were reported to be present in 23% of acral and 15.2% of mucosal melanomas (Heinrich MC et al, J Clin Oncol 26:2008 abstr 9016). Nilotinib is a novel tyrosine kinase inhibitor (TKI) targeting KIT, PDGFR, and Bcr-Abl and inhibiting the proliferating of both imatinib-sensitive and imatinib-resistant cells in vitro. Phase I study of nilotinib alone and in combination with imatinib in patients with imatinib-resistant gastrointestinal stromal tumors (GIST) demonstrated significant activity (72% stable disease for nilotinib alone and 56% for nilotinib/imatinib combination) (Blay JY et al, J Clin Oncol 26:2008, abstr 10553).

Thus, we propose to conduct a phase II study of nilotinib in metastatic melanoma with KIT mutations.

Study Design

Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Metastatic Melanoma With KIT Aberration

Intervention

Nilotinib

Location

Samsung Cancer Center
Seoul
Korea, Republic of

Status

Recruiting

Source

Samsung Medical Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:45-0400

Clinical Trials [1279 Associated Clinical Trials listed on BioPortfolio]

A Study of AMNN107 in the Treatment of Metastatic and/or Inoperable Melanoma Harboring a c-Kit Mutation

The purpose of this study is to determine whether nilotinib is efficacious in the treatment of metastatic and/or inoperable melanoma harboring a c-Kit mutation.

Nilotinib Pharmacokinetics (PK) in Gastrointestinal Stromal Tumor (GIST)

In patients who are receiving nilotinib, nilotinib plasma levels will be measured after 1 month of nilotinib treatment. The relationship between surgery type and nilotinib pharmakokinetic ...

Nilotinib in Patients With Relapsed or Metastatic Pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor/Diffuse-Type Giant Cell Tumor

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Treatment of Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumors in First Line With Nilotinib

The purpose of this multicenter, single-arm, exact binomial single-stage, phase II trial is to evaluate the efficacy of Nilotinib in patients with unresectable or metastatic gastrointestin...

Vaccine Therapy With or Without Interleukin-2 in Treating Patients With Metastatic Melanoma

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PubMed Articles [2379 Associated PubMed Articles listed on BioPortfolio]

Inhibition of DDR1-BCR signalling by nilotinib as a new therapeutic strategy for metastatic colorectal cancer.

The clinical management of metastatic colorectal cancer (mCRC) faces major challenges. Here, we show that nilotinib, a clinically approved drug for chronic myeloid leukaemia, strongly inhibits human C...

Comprehensive Histopathologic Comparison of Epidermotropic/Dermal Metastatic Melanoma and Primary Nodular Melanoma.

Metastatic melanoma involving the epidermis and/or upper dermis may show significant histologic overlap with primary cutaneous melanoma, especially the nodular subtype. Proper histopathologic classifi...

Laparoscopic liver resection for metastatic melanoma.

Stage IV metastatic melanoma carries a poor prognosis. In the case of melanoma liver metastasis (MLM), surgical resection may improve survival and represents a therapeutic option, with varying levels ...

Metastatic melanoma imaging using a novel Tc-99m-labeled lactam-cyclized alpha-MSH peptide.

The purpose of this study was to determine the metastatic melanoma imaging property of (99m)Tc(EDDA)-HYNIC-Aoc-Nle-CycMSHhex {hydrazinonicotinamide-8-aminooctanoic acid-Nle-c[Asp-His-DPhe-Arg-Trp-Lys]...

Nestin expression in primary and metastatic uveal melanoma - possible biomarker for high-risk uveal melanoma.

Nestin, a member of the intermediate filament protein family, has been described as a putative cancer stem cell marker (CSC) in uveal melanoma and poor prognostic factor in a variety of tumours, inclu...

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)

Experimentally induced tumor that produces MELANIN in animals to provide a model for studying human MELANOMA.

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.

Found in large amounts in the plasma and urine of patients with malignant melanoma. It is therefore used in the diagnosis of melanoma and for the detection of postoperative metastases. Cysteinyldopa is believed to be formed by the rapid enzymatic hydrolysis of 5-S-glutathionedopa found in melanin-producing cells.

A melanosome-specific protein that plays a role in the expression, stability, trafficking, and processing of GP100 MELANOMA ANTIGEN, which is critical to the formation of Stage II MELANOSOMES. The protein is used as an antigen marker for MELANOMA cells.

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