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

Phase 2

Terminated

• Conditions: Melanoma
• Interventions: Drug: TLN-232

• Registration Number: NCT00735332
• Lead Sponsor: Thallion Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-08-13
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Primary Completion: 2009-12
• Status Verified: 2010-08
• Last Update Submitted: 2010-08-04
• Last Update Posted: 2010-08-05
• Study Completion: 2010-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-Arm	TLN-232	-

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (4)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada

Hôpital Notre-Dame du CHUM; 🇨🇦 Montreal, Quebec, Canada

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada