- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00447356
High-Dose Interferon Alfa in Treating Patients With Stage II or StageIII Melanoma
May 9, 2013 updated by: Hackensack Meridian Health
Phase III Randomized Study of Four Weeks High Dose IFN-2b in StageT3-T4 or N1 (Microscopic) Melanoma
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New Jersey
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Hackensack, New Jersey, United States, 07601
- The Cancer Center at Hackensack University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: David S. Siegel, MD, Hackensack Meridian Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2000
Study Registration Dates
First Submitted
March 12, 2007
First Submitted That Met QC Criteria
March 12, 2007
First Posted (Estimate)
March 14, 2007
Study Record Updates
Last Update Posted (Estimate)
May 13, 2013
Last Update Submitted That Met QC Criteria
May 9, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antiviral Agents
- Antineoplastic Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
Other Study ID Numbers
- E1697 (Other Identifier: ECOG-ACRIN Cancer Research Group)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Melanoma (Skin)
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Rutgers, The State University of New JerseyNational Cancer Institute (NCI); University of VirginiaCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin Melanoma | Stage 0 Skin Melanoma | Stage I Skin Melanoma | Stage II Skin MelanomaUnited States
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
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National Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
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William CarsonSchering-PloughCompletedStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin MelanomaUnited States
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Roswell Park Cancer InstituteCompletedStage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IB Skin MelanomaUnited States
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Mayo ClinicNational Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin MelanomaUnited States
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Emory UniversityGenentech, Inc.Active, not recruitingStage IV Skin Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Unresectable Melanoma | Stage III Melanoma | Stage IIIA Skin Melanoma | Cutaneous Melanoma, Stage III | Cutaneous Melanoma, Stage IVUnited States
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National Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Mucosal Melanoma | Stage IIIA Skin MelanomaUnited States, Australia
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Fred Hutchinson Cancer CenterNational Cancer Institute (NCI); Incyte Corporation; University of VirginiaCompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Mucosal Melanoma | Stage IV Uveal Melanoma | Stage IIIA Skin Melanoma | Stage IIIA Uveal Melanoma | Stage IIIB Uveal Melanoma | Stage IIIC Uveal Melanoma | Recurrent Uveal MelanomaUnited States
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National Cancer Institute (NCI)CompletedStage IV Skin Melanoma | Recurrent Melanoma | Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage IIIA Skin MelanomaUnited States
Clinical Trials on recombinant interferon alfa
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedBrain and Central Nervous System TumorsUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedBladder Cancer | Urethral CancerUnited States
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Seoul National University HospitalHanyang UniversityRecruitingCoronary Artery Disease | Stable Angina | Acute Myocardial InfarctionKorea, Republic of
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)TerminatedBreast Cancer | Metastatic CancerUnited States
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Institute of Hematology & Blood Diseases Hospital...RecruitingEssential ThrombocytopeniaChina
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Institute of Hematology & Blood Diseases Hospital...RecruitingEssential ThrombocytopeniaChina
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Hoffmann-La RocheCompletedRenal Cell Carcinoma | Chronic Myelogenous Leukemia | Malignant MelanomaCanada, India, Bulgaria, Russian Federation, Spain, South Africa, Slovakia
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ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI); NCIC Clinical Trials Group; Children's Oncology... and other collaboratorsActive, not recruitingMelanoma (Skin)United States, Canada, Australia, South Africa
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Roswell Park Cancer InstituteNational Cancer Institute (NCI)SuspendedHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | Symptomatic COVID-19 Infection Laboratory-ConfirmedUnited States
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Institute of Cancer Research, United KingdomCompletedMelanoma (Skin)United Kingdom