Expired Study
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Philadelphia, Pennsylvania


Purpose:

The objective of this study is to assess the efficacy and safety of TLN-232 used to treat patients with metastatic melanoma that recur/progress after receiving first line systemic therapy.


Criteria:

Inclusion Criteria: - Histologically confirmed stage IV (M1a, M1b, and M1c) unresectable metastatic melanoma (cutaneous, mucosal or acral lentiginous) - First progression after treatment by one first line systemic therapy for metastatic melanoma (immunotherapy or targeted therapy or chemotherapy or any combination of them) - Measurable recurrent/progressive disease by radiological scan ≤ 21 days prior to Day 1, Cycle 1 - Age ≥ 18 years - ECOG ≤ 2 - Normal organ and marrow function as defined below: - Leukocytes ≥2.5 x 109/L - Absolute neutrophil count ≥1.5 x 109/L - Platelets ≥100 x 109/L - Hemoglobin ≥100 g/L (10g/dL) - Total bilirubin ≤1.5 X institutional ULN - AST(SGOT)/ALT(SGPT) ≤2.5 X institutional ULN - Creatinine ≤1.5 X institutional ULN Exclusion Criteria: - Patients with a life expectancy ≤ 16 weeks - Patients with ocular melanoma - Patients with symptomatic and/or unstable brain metastasis during the last 3 months (90 days) prior to Day 1, Cycle 1 - Patients with a history of allergic reactions or hypersensitivity to somatostatin analogues - Patients with a documented history of HIV, active hepatitis B or C infection - Female patients who are pregnant or lactating - Patients who are receiving hormonal therapy (with the exception of hormone replacement therapy and hormonal contraceptives), systemic steroids, immunosuppressive therapy or coumadin (low molecular weight heparin is permitted) - Patients with grade ≥2 peripheral neuropathy (CTCAE criteria) - Patients in whom a proper central line cannot be established


NCT ID:

NCT00735332


Primary Contact:

Principal Investigator
David Hogg, MD
Princess Margaret Hospital, Toronto


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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