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PEG-Intron Observation After Regional Lymph Node Dissection in AJCC Stage III (TxN1-2MO) Melanoma Patients: a Randomized Phase III Trial

Phase 3
18 Years
70 Years
Open (Enrolling)
Melanoma (Skin)

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Trial Information

PEG-Intron Observation After Regional Lymph Node Dissection in AJCC Stage III (TxN1-2MO) Melanoma Patients: a Randomized Phase III Trial


- Compare the effect of adjuvant therapy with pegylated interferon alfa vs observation,
in terms of distant metastases-free survival, in patients with previously resected
stage III melanoma.

- Compare the overall survival in these patients after treatment with pegylated
interferon alfa vs observation.

- Determine the toxicity of pegylated interferon alfa in these patients.

- Determine the compliance of these patients treated with pegylated interferon alfa.

- Compare the quality of life in these patients after treatment with pegylated interferon
alfa vs observation.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to type
of nodal involvement (N1 vs N2), number of positive nodes (1 vs 2-4 vs 5 or more vs not
assessed), Breslow primary (T1-2 vs T3 vs T4 vs unknown), ulceration of primary tumor
(absent vs present vs unknown), sex, and center. Patients are randomized to one of two
treatment arms.

- Arm I: Patients receive pegylated interferon alfa subcutaneously weekly for 5 years.

- Arm II: Patients undergo observation only. Treatment continues in the absence of
distant metastases or unacceptable toxicity.

Quality of life is assessed at baseline, and then at months 3, 12, 24, 36, 48, and 60.

Patients are followed every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 1,200 patients (600 per treatment arm) will be accrued for
this study within 1.5-2 years.

Inclusion Criteria


- Histologically confirmed previously resected stage III primary cutaneous melanoma or
unknown primary with regional lymph node involvement

- N1 disease

- Microscopic, nonpalpable nodal involvement

- Primary melanoma of any stage with clinically inapparent N1 regional lymph
node metastases (T1-4, N1, M0) detected by elective lymph node dissection
or sentinel node biopsy

- N2 disease

- Palpable nodal involvement with synchronous primary melanoma or apparent
nodal disease after prior excision (any pT, N2, M0)

- Regional lymph node recurrence at any interval after surgery for primary
melanoma of any depth (T1-4, rN2, M0)

- Complete resection of primary melanoma with adequate surgical margins

- Full lymphadenectomy must be performed within 70 days of study

- No mucous membrane melanoma or ocular melanoma

- No evidence of distant or nonregional lymph node metastases or in transit metastases
(even if previously resected)

- No incompletely resected disease due to gross extracapsular extension



- 18 to 70

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified


- WBC at least 3,000/mm^3

- Platelet count greater than 100,000/mm^3

- Hemoglobin at least 9 g/dL


- SGOT and SGPT less than 2 times upper limit of normal

- No active hepatitis


- Creatinine less than 2.0 mg/dL


- No severe cardiovascular disease including the following:

- Arrhythmias requiring chronic treatment

- Congestive heart failure (New York Heart Association class III or IV)

- Symptomatic ischemic heart disease


- No other prior malignancy within the past 5 years except surgically cured
nonmelanomatous skin cancer or carcinoma in situ of the cervix

- No thyroid dysfunction unresponsive to therapy

- No uncontrolled diabetes mellitus

- No active autoimmune disease

- No active and/or uncontrolled infection

- No history of neuropsychiatric disorder requiring hospitalization

- No known active alcohol or drug abuse

- HIV negative

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy:

- No prior interferon alfa

- No prior immunotherapy for melanoma

- No other concurrent immunologic or biologic therapy

- No concurrent colony stimulating factors including epoetin alfa and filgrastim


- No prior chemotherapy for melanoma

- No concurrent chemotherapy

Endocrine therapy:

- No prior hormonal therapy for melanoma

- No concurrent hormonal therapy

- No concurrent chronic systemic corticosteroid therapy


- No prior radiotherapy for melanoma

- No concurrent radiotherapy


- See Disease Characteristics

- Recovered from any prior recent surgery


- At least 30 days since other prior experimental therapy

- No other concurrent investigational drugs

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

distant-metastasis free-survival (DMFS)

Outcome Description:

distant-metastasis free-survival (DMFS) after randomization

Outcome Time Frame:

from randomization

Safety Issue:


Principal Investigator

Alexander M. M. Eggermont, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Daniel Den Hoed Cancer Center at Erasmus Medical Center


United States: Federal Government

Study ID:




Start Date:

June 2000

Completion Date:

Related Keywords:

  • Melanoma (Skin)
  • stage III melanoma
  • Melanoma