High-Dose Interferon Alfa in Treating Patients With Stage II or Stage III Melanoma

This study has suspended participant recruitment.
Sponsor:
Collaborators:
Southwest Oncology Group
Cancer and Leukemia Group B
NCIC Clinical Trials Group
Children's Oncology Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003641
First received: November 1, 1999
Last updated: July 11, 2012
Last verified: July 2011
  Purpose

RATIONALE: Interferon alfa may interfere with the growth of cancer cells. It is not yet known whether treatment with interferon alfa is more effective than observation alone for stage II or stage III melanoma that has been completely removed surgically.

PURPOSE: This randomized phase III trial is studying high dose interferon alfa to see how well it works compared to observation only in treating patients with stage II or stage III melanoma that has been completely removed by surgery.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Four Weeks of High Dose Interferon Alfa-2b in Stage TN ,TN, TN, and T, N (Microscopic) Melanoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Disease control interval [ Designated as safety issue: No ]
  • Interferon alfa-2b toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment: 1420
Study Start Date: December 1998
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm I
Patients undergo observation for 4 weeks.
Other: clinical observation
Patients undergo observation for 4 weeks.
Experimental: Arm II
Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.
Biological: recombinant interferon alfa
Given IV

Detailed Description:

OBJECTIVES:

  • Compare the effect of high-dose interferon alfa-2b treatment on the relapse-free survival of patients with stage II or III resected malignant melanoma.
  • Compare the effect of this treatment regimen on overall survival of these patients.
  • Assess the toxicity of this treatment in these patients.
  • Compare the effect of treatment on quality-adjusted survival.

OUTLINE: This is a randomized study. Patients are stratified by pathologic lymph node status (known vs unknown by sentinel lymph node procedure vs by elective lymph node dissection vs by no lymphadenectomy), Breslow depth (< 1.0 mm [lymph node positive patients only] vs 1.01-2.0 mm vs 2.01-4.0 mm vs > 4.0 mm), ulceration of the primary lesion (yes vs no vs unknown), and disease stage (lymph node positive [N_1a, N_2a microscopic] vs lymph node negative [N_0]). Patients are randomized into one of two treatment arms.

  • Arm I: Patients undergo observation for 4 weeks.
  • Arm II: Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.

Quality of life is assessed before treatment, at day 22, every 3 months for 2 years, and then every 6 months for 3 years.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 1,420 patients will be accrued for this study over 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed primary melanoma of cutaneous origin

    • Stage II (T3 N0 M0 1.5-4.0 mm Breslow depth)

      • Clinically negative regional lymph node pathologic status unknown OR
      • Histologically negative regional lymph nodes
    • Stage III (T4 N0 M0)

      • Greater than 4.0 mm Breslow depth OR
    • Stage III (T1-4 N1)

      • One lymph node positive microscopically
  • Patients must meet at least 1 of the following criteria:

    • T_2b N_0 - primary melanoma 1.01-2.0 mm with ulceration, node negative
    • T_3a-b N_0 - primary melanoma 2.01-4.0 mm with and without ulceration, node negative
    • T_4a-b N_0 - primary melanoma > 4.0 mm with or without ulceration, node negative
    • T_1-a N_1a-2a (microscopic) - primary melanoma of any thickness with microscopically positive lymph node (any number)
  • Patients with a positive sentinel node should undergo complete lymphadenectomy of the nodal basin prior to study
  • Must complete all primary therapy (wide excision with or without lymphadenectomy) and be randomized in this study within 84 days of wide excision
  • Must have undergone an adequate wide excision of the primary lesion
  • No clinical, radiological/laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease
  • No clinically palpable lymphadenopathy

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 3,000/mm^3
  • Platelet count at least 125,000/mm^3
  • Hematocrit at least 30%

Hepatic:

  • Bilirubin no greater than 2 times upper limit of normal (ULN)
  • AST, LDH, and alkaline phosphatase no greater than 2 times ULN
  • If lactate dehydrogenase or alkaline phosphatase is above normal, a contrast-enhanced CT scan or MRI of the liver is required to document the absence of tumor

Renal:

  • BUN no greater than 33 mg/dL OR
  • Creatinine no greater than 1.8 mg/dL

Cardiovascular:

  • No history of active ischemic heart disease
  • No cerebrovascular disease
  • No congestive heart failure (New York Heart Association class III or IV heart disease)

Other:

  • No other history of invasive melanoma
  • No autoimmune disorders or conditions of immunosuppression
  • No other concurrent or prior malignancies within the past 5 years except:

    • Cancer in situ
    • Lobular carcinoma in situ of the breast
    • Carcinoma in situ of the cervix
    • Atypical melanocytic hyperplasia or Clark 1 melanoma in situ
    • Basal or squamous cell skin cancer
  • No evidence of organic brain syndrome or significant impairment of basal cognitive function or any psychiatric disorder that would preclude study participation
  • No other significant medical or surgical condition, or any medication or treatment regimens, that would interfere with study participation
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior immunotherapy including tumor vaccines, interferon, interleukins, levamisole, or other biologic response modifiers for melanoma

Chemotherapy:

  • No prior or concurrent chemotherapy

Endocrine therapy:

  • No concurrent systemic corticosteroids including oral steroids (i.e., prednisone, dexamethasone), topical steroid creams or ointments, or any steroid-containing inhalers

Radiotherapy:

  • No prior or concurrent radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • No other concurrent immunosuppressive medications
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003641

  Show 533 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Southwest Oncology Group
Cancer and Leukemia Group B
NCIC Clinical Trials Group
Children's Oncology Group
Investigators
Study Chair: Sanjiv S. Agarwala, MD St. Luke's Cancer Network at St. Luke's Hospital
Investigator: John M. Kirkwood, MD UPMC Cancer Center at UPMC Presbyterian
Study Chair: Lawrence E. Flaherty, MD Barbara Ann Karmanos Cancer Institute
Study Chair: William E. Carson, MD Ohio State University Comprehensive Cancer Center
Study Chair: Michael Smylie, MD, MB, ChB Cross Cancer Institute at University of Alberta
Principal Investigator: Alberto S. Pappo, MD Texas Children's Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Robert L. Comis, ECOG Group Chair's Office
ClinicalTrials.gov Identifier: NCT00003641     History of Changes
Other Study ID Numbers: CDR0000066727, ECOG-1697, SWOG-E1697, CALGB-500103, CAN-NCIC-ME10, COG-E1697
Study First Received: November 1, 1999
Last Updated: July 11, 2012
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Interferon-alpha
Interferon Alfa-2a
Interferon Alfa-2b
Interferons
Reaferon
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Adjuvants, Immunologic
Alcohol Deterrents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 23, 2014