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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00447356
Recruitment Status : Withdrawn (There were no patient enrolled in this study at this site)
First Posted : March 14, 2007
Last Update Posted : May 13, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Hackensack Meridian Health

Brief Summary:
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 or disease Intervention/treatment Phase
Melanoma (Skin) Drug: recombinant interferon alfa Phase 3

Detailed Description:
Interferon alfa may interfere with 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase III Randomized Study of Four Weeks High Dose IFN-2b in StageT3-T4 or N1 (Microscopic) Melanoma
Study Start Date : January 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Histologically confirmed primary melanoma of cutaneous origin
  • Stage II (T3 N0 M0 1.5-4.0mm Breslow depth
  • Clinically negative regional lymph node pathologic status unkown OR
  • Histologically negative regional lymph nodes
  • Stage III (T4 N0 M0)
  • Greater than 4.0mm Breslow depth OR
  • Stage III (T1-4 N1)
  • One lymph node positive microscopically
  • Patients must meet at least 1 of the following criteria
  • T2b N0 primary melanoma 1.01-2.0mm with ulceration, node negative
  • T3a-b N0 primary melanoma 2.01-4.0mm with and without ulceration, node negative
  • T4a-b N0 primary melanoma > 4.0mm with and without ulceration, node negative
  • T1aN1a-2a (microscopic)-primary melanoma of any thickness with microscopically positive lymph node (any number)
  • Note EORTC patients who are node negative T2 or T3 are ineligible
  • Patients with 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 the study within 84 days of wide excision
  • No clinical, radiological/laboratory, or pathological evidence of incompletely resected melanoma or any distant metastatic disease
  • No clinically palpable lymphadenopathy


  • 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%


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


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


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

Exclusion Criteria:

Biologic Therapy:

  • No prior immunotherapy including tumor vaccines, interferon, interleukins,levamisole, or other biologic response modifers for melanoma Chemotherapy
  • No prior or concurrent chemotherapy Endocrine Therapy
  • No concurrent systemic corticosteriods including oral steriods (i.e., prednisone, dexamethasone), topical steroid creams or ointments, or any steriod-containing inhalers.


  • No Prior or concurrent radiotherapy


  • See Disease characteristics


  • No other concurrent immunosuppressive medications
  • No other history of invasive melanoma
  • No autoimmune disorders or conditions of immunosuppression
  • No other concurrent or prior malignancies within past 5 years
  • Cancer in situ
  • Lobular carcinoma in situ of 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00447356

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United States, New Jersey
The Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Sponsors and Collaborators
Hackensack Meridian Health
National Cancer Institute (NCI)
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Principal Investigator: David S. Siegel, MD Hackensack Meridian Health

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Responsible Party: Hackensack Meridian Health Identifier: NCT00447356     History of Changes
Other Study ID Numbers: E1697
First Posted: March 14, 2007    Key Record Dates
Last Update Posted: May 13, 2013
Last Verified: May 2013
Additional relevant MeSH terms:
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Nevi and Melanomas
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs