Efficacy Study of TLN-232 in Patients With Recurring Metastatic Melanoma

Stopped early · Phase 2

Conditions studied: Melanoma

In brief

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.

Key facts

Study ID

NCT00735332

Run by

Thallion Pharmaceuticals

People needed

49

Starts

2008-08-01

Expected to finish

2010-10-01

Last updated by the study team

2010-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Juravinski Cancer Centre — Hamilton, Ontario, Canada
• Princess Margaret Hospital — Toronto, Ontario, Canada
• Hôpital Notre-Dame du CHUM — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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