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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00735332
Recruitment Status : Terminated (License termination.)
First Posted : August 14, 2008
Last Update Posted : August 5, 2010
Sponsor:
Information provided by:
Thallion Pharmaceuticals

Study Description
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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.

Condition or disease Intervention/treatment Phase
Melanoma Drug: TLN-232 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IIa Study of TLN-232 as Second-line Therapy for Patients With Metastatic Melanoma
Study Start Date : August 2008
Actual Primary Completion Date : December 2009
Estimated Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Single-Arm Drug: TLN-232
21 day continuous IV administration of TLN-232 followed by a 7-day recovery period
Other Name: Formerly CAP-232


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00735332


Locations
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United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Canada, Quebec
Hôpital Notre-Dame du CHUM
Montreal, Quebec, Canada
Sponsors and Collaborators
Thallion Pharmaceuticals
Investigators
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Principal Investigator: David Hogg, MD Princess Margaret Hospital, Toronto
More Information
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Responsible Party: Didier Reymond, MD / Executive Vice-President Clinical Development, Thallion Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00735332    
Other Study ID Numbers: TLN-232-202
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: August 5, 2010
Last Verified: August 2010
Keywords provided by Thallion Pharmaceuticals:
Melanoma
Metastatic Melanoma
Phase II
Skin Cancer
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas