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

This study has been terminated.
(License termination.)
Sponsor:
Information provided by:
Thallion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00735332
First received: August 13, 2008
Last updated: August 4, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Melanoma
Drug: TLN-232
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IIa Study of TLN-232 as Second-line Therapy for Patients With Metastatic Melanoma

Resource links provided by NLM:


Further study details as provided by Thallion Pharmaceuticals:

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). [ Time Frame: Complete response, partial response or stable disease at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 49
Study Start Date: August 2008
Estimated Study Completion Date: October 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00735332

Locations
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
Principal Investigator: David Hogg, MD Princess Margaret Hospital, Toronto
  More Information

No publications provided

Responsible Party: Didier Reymond, MD / Executive Vice-President Clinical Development, Thallion Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00735332     History of Changes
Other Study ID Numbers: TLN-232-202
Study First Received: August 13, 2008
Last Updated: August 4, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by Thallion Pharmaceuticals:
Melanoma
Metastatic Melanoma
Phase II
Skin Cancer

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas

ClinicalTrials.gov processed this record on October 23, 2014