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Interferon Alfa or No Further Therapy Following Surgery in Treating Patients With Stage II, Stage III, or Recurrent Melanoma

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00002892
First received: November 1, 1999
Last updated: December 18, 2013
Last verified: May 2007
  Purpose

RATIONALE: Interferon alfa may interfere with the growth of the cancer cells. It is not yet known whether interferon alfa following surgery is more effective than surgery alone in treating patients with melanoma.

PURPOSE: Randomized phase III trial to compare the effectiveness of interferon alfa with no further therapy following surgery in treating patients with stage II, stage III, or recurrent melanoma.


Condition Intervention Phase
Melanoma (Skin)
Biological: recombinant interferon alfa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A RANDOMISED STUDY OF OBSERVATION VERSUS ADJUVANT LOW DOSE EXTENDED DURATION INTERFERON ALPHA-2A IN COMPLETELY RESECTED HIGH RISK MALIGNANT MELANOMA

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 1000
Study Start Date: October 1995
Study Completion Date: December 2001
Detailed Description:

OBJECTIVES: I. Determine the effects of adjuvant low-dose extended-duration interferon alfa on disease-free and overall survival in patients with completely resected malignant melanoma at high risk of recurrence. II. Determine any correlation between patient age or sex and the effects of interferon therapy on disease-free and overall survival. III. Describe the toxic effects of this treatment. IV. Evaluate the economic implications of implementing effective interferon therapy in these patients.

OUTLINE: This is a randomized study. Patients will be stratified by age, sex, disease status at entry, and participating institution. Patients are randomized to observation only or to receive interferon alfa by subcutaneous injections 3 times weekly for 2 years, or until disease progression or toxicity intervenes. Patients are followed monthly for 6 months, quarterly for 18 months, and every 6 months thereafter.

PROJECTED ACCRUAL: A total of 1,000 patients will be entered over 5 years.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma definitively resected within 12 weeks prior to entry One of the following categories: Stage II disease (greater than 4 mm Breslow thickness) Stage III disease (regional lymph node involvement) Recurrent non-nodal superficial regional disease (local or in transit) Recurrent regional nodal involvement

PATIENT CHARACTERISTICS: Able to tolerate interferon No second malignancy except curatively treated: Carcinoma of the cervix Nonmelanomatous skin cancer No pregnant or nursing women

PRIOR CONCURRENT THERAPY: No prior immunosuppressive therapy, including systemic steroids No prior biologic therapy Recovered from surgery

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002892

Locations
United Kingdom
Royal Free Hospital
Hampstead, London, England, United Kingdom, NW3 2QG
St. James's Hospital
Leeds, England, United Kingdom, LS9 7TF
University Hospitals of Leicester
Leicester, England, United Kingdom, LE1 5WW
Royal Marsden NHS Trust
London, England, United Kingdom, SW3 6JJ
Guy's, King's and St. Thomas' Hospitals Trust
London, England, United Kingdom, SE1 7EH
Christie Hospital N.H.S. Trust
Manchester, England, United Kingdom, M20 4BX
Clatterbridge Centre for Oncology NHS Trust
Merseyside, England, United Kingdom, L63 4JY
Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Selly Oak Hospital
Birmingham, United Kingdom, B29 6JD
Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW
Queen Elizabeth Hospital
King's Lynn, United Kingdom, PE30 4ET
Salisbury District Hospital
Salisbury, United Kingdom, SP2 8BJ
Southend Hospital
Southend on Sea, United Kingdom, SS0 0RY
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
Study Chair: Barry W. Hancock, MD Cancer Research Centre at Weston Park Hospital
  More Information

Additional Information:
Publications:
Hancock BW, Wheatley K, Harrison G, et al.: Aim high-adjuvant interferon In melanoma (high risk), A United Kingdom Co-Ordinating Committee On Cancer Research (UKCCCR) randomised study of observation versus adjuvant low dose extended duration interferon Alpha-2a In high risk resected malignant melanoma. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-1393, 2001.

ClinicalTrials.gov Identifier: NCT00002892     History of Changes
Other Study ID Numbers: CDR0000065215, NCRI-AIM-HIGH, EU-96052, UKCCCR-AIM-HIGH
Study First Received: November 1, 1999
Last Updated: December 18, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage II melanoma
stage III melanoma
recurrent melanoma

Additional relevant MeSH terms:
Melanoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Interferon-alpha
Interferons
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014