Clinical trial NCT00735332: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Melanoma
Keywords: Melanoma
Metastatic Melanoma
Phase II
Skin Cancer
Lead sponsor: Thallion Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-08-14
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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).
timeFrame: Complete response, partial response or stable disease at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1)
Secondary outcomes:
measure: To examine the safety and tolerability of TLN-232 in patients with recurrent metastatic melanoma
timeFrame: Maximum 13 months from date of initial infusion of TLN-232 (Day 1, Cycle 1)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
city: Montreal
country: Canada
facility: Hôpital Notre-Dame du CHUM
state: Quebec
Study officials:
affiliation: Princess Margaret Hospital, Toronto
name: David Hogg, MD
role: PRINCIPAL_INVESTIGATOR
References: