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

Melanoma Clinical Trial

Official title:

A Phase IIa Study of TLN-232 as Second-line Therapy for Patients With Metastatic Melanoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00735332
• Other study ID #: TLN-232-202
• Status: Terminated
• Phase: Phase 2
• First received: August 13, 2008
• Last updated: August 4, 2010
• Start date: August 2008
• Est. completion date: October 2010

Study information

• Verified date: August 2010
• Source: Thallion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 49
• Est. completion date: October 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• TLN-232
21 day continuous IV administration of TLN-232 followed by a 7-day recovery period

Locations

Country	Name	City	State
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	Hôpital Notre-Dame du CHUM	Montreal	Quebec
Canada	Princess Margaret Hospital	Toronto	Ontario
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thallion Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the efficacy of TLN-232 in patients with recurrent metastatic melanoma measured by overall response rate at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1).		Complete response, partial response or stable disease at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1)	No
Secondary	To examine the safety and tolerability of TLN-232 in patients with recurrent metastatic melanoma		Maximum 13 months from date of initial infusion of TLN-232 (Day 1, Cycle 1)	Yes