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Melanoma (Skin)Phase 3NCT00447356

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

A Phase 3 study testing recombinant interferon alfa in people with Melanoma (Skin), run by Hackensack Meridian Health at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma (Skin)
What is being tested?
recombinant interferon alfa
How many people
0 participants
Where
1 siteUnited States
Study dates
Jan 2000to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Who may be able to join

  • 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
Show all 38Show fewer
  • 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)

Who cannot join

  • 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
Show all 23Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Melanoma (Skin)
Being tested
recombinant interferon alfa
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • recombinant interferon alfaDrug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2007 (estimated)
  2. Study startJan 2000

Why it stopped: There were no patient enrolled in this study at this site

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00447356
Sponsor's protocol ID
E1697
Status last verified
May 2013
First submitted
12 Mar 2007
Last updated
13 May 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Slawek-Szmyt S, Araszkiewicz A, Jankiewicz S, Grygier M, Mularek-Kubzdela T, Lesiak M. Outcomes With Hybrid Catheter-Directed Therapy Compared With Aspiration Thrombectomy for Patients With Intermediate-High Risk Pulmonary Embolism. Cardiovasc Drugs Ther. 2025 Oct;39(5):1201-1213. doi: 10.1007/s10557-024-07562-4. Epub 2024 Apr 2.

    PubMed 38564122

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing recombinant interferon alfa in people with Melanoma (Skin), run by Hackensack Meridian Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 13 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00447356, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2013; AzTrials last refreshed its copy on 6 Nov 2026.

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