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

NCT ID: NCT00735332

Last Updated: 2010-08-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2010-10-31

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.

Conditions

Melanoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single-Arm

Group Type: EXPERIMENTAL

TLN-232

Intervention Type: DRUG

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

Interventions

TLN-232

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

Intervention Type: DRUG

Other Intervention Names

Formerly CAP-232

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thallion Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Thallion Pharmaceuticals Inc.

Principal Investigators

David Hogg, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Toronto

Locations

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

Countries

United States; Canada

Other Identifiers

TLN-232-202

Identifier Type: -

Identifier Source: org_study_id