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A Phase IIa Study of TLN-232 as Second-line Therapy for Patients With Metastatic Melanoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

A Phase IIa Study of TLN-232 as Second-line Therapy for Patients With Metastatic Melanoma


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome 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).

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

David Hogg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Toronto

Authority:

United States: Food and Drug Administration

Study ID:

TLN-232-202

NCT ID:

NCT00735332

Start Date:

August 2008

Completion Date:

October 2010

Related Keywords:

  • Melanoma
  • Melanoma
  • Metastatic Melanoma
  • Phase II
  • Skin Cancer
  • Melanoma

Name

Location

Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111