Clincosm LogoSign in Get a demo

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

Sponsor
Hackensack Meridian Health (Other)
Overall Status
Withdrawn
CT.gov ID
NCT00447356
Collaborator
National Cancer Institute (NCI) (NIH)
0
Enrollment
1
Location

Study Details

Study Description

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
  • 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.

Study Design

Study Type:
Interventional
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 :
Jan 1, 2000

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    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 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

    Renal:

    • BUN no greater than 33mg/dl OR

    • Creatinine no greater than 1.8mg/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)

    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.

    Radiotherapy:
    • No Prior or concurrent radiotherapy
    Surgery:
    • See Disease characteristics
    Other:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Cancer Center at Hackensack University Medical Center Hackensack New Jersey United States 07601

    Sponsors and Collaborators

    • Hackensack Meridian Health
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: David S. Siegel, MD, Hackensack Meridian Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hackensack Meridian Health
    ClinicalTrials.gov Identifier:
    NCT00447356
    Other Study ID Numbers:
    • E1697
    First Posted:
    Mar 14, 2007
    Last Update Posted:
    May 13, 2013
    Last Verified:
    May 1, 2013
    Additional relevant MeSH terms:
    Melanoma
    Interferons
    Interferon-alpha

    Study Results

    No Results Posted as of May 13, 2013