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Adjuvant Pegylated-Interferon-alpha2b (SylatronTM) for 2 Years Versus Observation in Patients With an Ulcerated Primary Cutaneous Melanoma With T(2-4)bN0M0: a Randomized Phase III Trial of the EORTC Melanoma Group.


Phase 3
18 Years
70 Years
Open (Enrolling)
Both
Ulcerated Melanomas

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Trial Information

Adjuvant Pegylated-Interferon-alpha2b (SylatronTM) for 2 Years Versus Observation in Patients With an Ulcerated Primary Cutaneous Melanoma With T(2-4)bN0M0: a Randomized Phase III Trial of the EORTC Melanoma Group.


Inclusion Criteria:



- Subjects must be between 18-70 years old.

- Subjects must have histologically documented ulcerated primary cutaneous melanomas
with T(2-4)b N0M0.

Adequate resection of ulcerated primary cutaneous melanoma. 1 to 2 cm normal tissue
excision margins according to Breslow thickness are recommended. In the head and neck
areas and in case of locations distally on extremities, narrower margins are acceptable as
long as they are radical (see Appendix F). Subjects must have recovered from the effects
of recent surgery.

- SNB must occur within 12 weeks prior randomization.

- Subjects must have an ECOG performance status of 0 or 1 (See Appendix B).

- Subjects must have adequate bone marrow, renal and hepatic function as defined by the
following parameters obtained up to maximum 12 weeks prior to randomization:

- Hematology:

- WBC >= 3.0 x 109/L

- Neutrophils > 1.5 x 109/L

- Platelets > 100 x 109/L

- Hemoglobin >= 9 g/dL or 5.6 mmol/L

- Adequate Renal and Hepatic function:

- Serum creatinine < 2.0 mg/dL or < 140 ┬Ámol/L

- SGOT and SGPT < 2 times upper normal limit of laboratory normal (ULN)

Exclusion Criteria:

- No mucosal melanoma nor ocular melanoma.

- No evidence of nodal involvement confirmed by sentinel lymph node biopsy (SNB).
Sentinel Node staging after the excision of the primary must be done between the date
of final excision of the primary and the date of randomization.

- No evidence of regional nor distant lymph node metastases nor satellites/in-transit
metastases (even if they have been resected).

- No evidence of distant metastasis on clinical examination, CT/MRI of full chest,
abdomen and pelvis. Neck CT/MRI if head and neck primary.

- No clinical evidence of brain metastasis.

- No pregnant women

- No breast feeding women

- No patients with a medical condition requiring chronic systemic corticosteroids are
not eligible.

- No experimental therapy within 30 days prior to randomization in this study.

- No prior chemotherapy, immunotherapy/vaccine, hormonal or radiation therapy for
melanoma.

- No prior treatment with interferon-alfa for any reason.

- No history of prior malignancy within the past 5 years other than surgically cured
non-melanoma skin cancer or cervical carcinoma in situ.

- No severe cardiovascular disease, i.e. arrhythmias requiring chronic treatment,
congestive heart failure (NYHA Class III or IV) nor symptomatic ischemic heart
disease.

- No thyroid dysfunction not responsive to therapy.

- No poorly controlled (HBA1C>8%) diabetes mellitus or uncontrolled diabetes mellitus,
i.e. elevated fasting serum glucose should be < 110% ULN).

- No active autoimmune disease.

- No active and/or uncontrolled infection, including active hepatitis.

- No history of seropositivity for HIV.

- No history of neuropsychiatric disorder requiring hospitalization.

- Absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule;
those conditions should be discussed with the patient before registration in the
trial.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Relapse-free survival (RFS)

Outcome Time Frame:

6.3 years from first patient in

Safety Issue:

No

Principal Investigator

Alessandro Testori, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

ISTITUTO EUROPEO DI ONCOLOGIA, Milano, Italy

Authority:

Austria: Agency for Health and Food Safety

Study ID:

EORTC-18081

NCT ID:

NCT01502696

Start Date:

October 2012

Completion Date:

Related Keywords:

  • Ulcerated Melanomas
  • ulcerated primary cutaneous melanoma
  • Stage II
  • PEG IFN alfa-2b
  • T(2-4)bN0M0
  • Melanoma
  • Ulcer

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