Status:
TERMINATED
Efficacy Study of TLN-232 in Patients With Recurring Metastatic Melanoma
Lead Sponsor:
Thallion Pharmaceuticals
Conditions:
Melanoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00735332
Start Date
August 1 2008
End Date
October 1 2010
Last Update
August 5 2010
Active Locations (4)
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1
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
2
Juravinski Cancer Centre
Hamilton, Ontario, Canada
3
Princess Margaret Hospital
Toronto, Ontario, Canada
4
Hôpital Notre-Dame du CHUM
Montreal, Quebec, Canada