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

Primary Purpose

Melanoma

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TLN-232
Sponsored by
Thallion Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Melanoma focused on measuring Melanoma, Metastatic Melanoma, Phase II, Skin Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fox Chase Cancer Center
  • Juravinski Cancer Centre
  • Princess Margaret Hospital
  • Hôpital Notre-Dame du CHUM

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single-Arm

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

To examine the safety and tolerability of TLN-232 in patients with recurrent metastatic melanoma

Full Information

First Posted
August 13, 2008
Last Updated
August 4, 2010
Sponsor
Thallion Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00735332
Brief Title
Efficacy Study of TLN-232 in Patients With Recurring Metastatic Melanoma
Official Title
A Phase IIa Study of TLN-232 as Second-line Therapy for Patients With Metastatic Melanoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Terminated
Why Stopped
License termination.
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Thallion Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Melanoma
Keywords
Melanoma, Metastatic Melanoma, Phase II, Skin Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single-Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TLN-232
Other Intervention Name(s)
Formerly CAP-232
Intervention Description
21 day continuous IV administration of TLN-232 followed by a 7-day recovery period
Primary Outcome Measure Information:
Title
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).
Time Frame
Complete response, partial response or stable disease at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1)
Secondary Outcome Measure Information:
Title
To examine the safety and tolerability of TLN-232 in patients with recurrent metastatic melanoma
Time Frame
Maximum 13 months from date of initial infusion of TLN-232 (Day 1, Cycle 1)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hogg, MD
Organizational Affiliation
Princess Margaret Hospital, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
Country
United States
Facility Name
Juravinski Cancer Centre
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Hôpital Notre-Dame du CHUM
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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