NCT00735332

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2008

Geographic Reach
2 countries

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

August 13, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

August 5, 2010

Status Verified

August 1, 2010

Enrollment Period

1.3 years

First QC Date

August 13, 2008

Last Update Submit

August 4, 2010

Conditions

Melanoma

Keywords

MelanomaMetastatic MelanomaPhase IISkin Cancer

Outcome Measures

Primary Outcomes (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).

    Complete response, partial response or stable disease at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1)

Secondary Outcomes (1)

  • 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)

Study Arms (1)

Single-Arm

EXPERIMENTAL
Drug: TLN-232

Interventions

TLN-232DRUG

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

Also known as: Formerly CAP-232
Single-Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Location

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, Canada

Location

Hôpital Notre-Dame du CHUM

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

MelanomaSkin Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • David Hogg, MD

    Princess Margaret Hospital, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 13, 2008

First Posted

August 14, 2008

Study Start

August 1, 2008

Primary Completion

December 1, 2009

Study Completion

October 1, 2010

Last Updated

August 5, 2010

Record last verified: 2010-08

Locations

US(1)CA(3)