Melanoma (Skin)Phase 3NCT00003444
Interferon Alfa-2b With or Without Radiation Therapy in Treating Patients With Melanoma That Has Metastasized to Lymph Nodes in the Neck, Under the Arm, or in the Groin
A Phase 3 study testing recombinant interferon alfa and radiation therapy in people with Melanoma (Skin), run by Eastern Cooperative Oncology Group at 23 sites in United States.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Interferon alfa-2b may interfere with the growth of cancer cells. It is not yet known whether giving radiation therapy with interferon alfa-2b is more effective than giving interferon alfa-2b alone in treating melanoma. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- recombinant interferon alfa and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 167 participants
- Where
- 23 sitesUnited States
- Study dates
- 29 Mar 1999to Sep 2003
- 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 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS: Histologically documented malignant melanoma in node(s) meeting one or more of the following criteria: 1 or more lymph nodes found to contain metastatic melanoma with gross evidence of extracapsular nodal extension Nodal recurrence at the site of previous lymphadenectomy All gross cancer removed with negative margins Prior node biopsy allowed if complete nodal dissection performed Parotid involvement outside a node allowed No distant metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 125,000/mm3 Hematocrit at least 33% Hepatic: AST no greater than 2 times upper limit of normal (ULN) LDH no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Bilirubin no greater than 2 times ULN If LDH or alkaline phosphatase are above normal, CT or MRI of liver required Renal: Creatinine no greater than 1.8 mg/dL BUN no greater than 33 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No other prior or concurrent malignancies within 2 years, except any carcinoma in situ, lobular carcinoma of the breast in situ, carcinoma in situ of the cervix, atypical melanocytic hyperplasia or Clark I melanoma in situ, or basal or squamous cell skin cancer
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior interferon Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head and neck, axillary, or inguinal areas Surgery: See Disease Characteristics Recovered from prior surgery
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Veterans Affairs Medical Center - Albany
Albany, New York, 12208
Emory University Hospital - Atlanta
Atlanta, Georgia, 30322
New England Medical Center Hospital
Boston, Massachusetts, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
Veterans Affairs Medical Center - Chicago (Lakeside)
Chicago, Illinois, 60611
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
CCOP - Geisinger Clinical and Medical Center
Danville, Pennsylvania, 17822-2001
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
CCOP - Central Illinois
Decatur, Illinois, 62526
CCOP - Duluth
Duluth, Minnesota, 55805
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
Hackensack University Medical Center
Hackensack, New Jersey, 07601
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15213
UPMC St. Margaret
Pittsburgh, Pennsylvania, 15215
Riverview Medical Center
Red Bank, New Jersey, 07701
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, 55416
About this study
Official title: A Prospective Randomized Phase III Clinical Trial Assessing the Role of Post-Operative Radiotherapy Plus Adjuvant Interferon Alpha-2b in Patients With Cervical, Axillary, and Inguinal Nodal Metastasis From Cutaneous Melanoma
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Interferon alfa-2b may interfere with the growth of cancer cells. It is not yet known whether giving radiation therapy with interferon alfa-2b is more effective than giving interferon alfa-2b alone in treating melanoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus interferon alfa-2b with that of interferon alfa-2b alone in treating patients who have melanoma that has metastasized to lymph nodes in the neck, under the arm, or in the groin.
Read the detailed description
OBJECTIVES: I. Evaluate the effectiveness of postoperative hypofractionated radiotherapy in combination with high dose interferon in preventing regional relapse in patients with malignant melanoma with any number of nodes with clinical extracapsular extension or previous nodal basin recurrence. II. Evaluate the effectiveness of this therapy in prolonging relapse free and overall survival in this patient population. III. Evaluate the toxicity of this therapy in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to prior nodal basin recurrence, site of disease, and extracapsular extension. Following surgery, patients are randomized to receive either interferon alfa-2b alone or five treatments of radiotherapy followed by interferon alfa-2b. Patients receive radiotherapy 2 days a week for 2.5 weeks. Patients receive interferon alfa-2b IV over 20 minutes daily for 5 days for a total of 28 days, followed by subcutaneous injections 3 times a week for 48 weeks. Patients are followed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: Approximately 167 patients will be accrued for this study within 3 years.
- Conditions
- Melanoma (Skin)
- Being tested
- recombinant interferon alfa, radiation therapy
- Keywords
- stage III melanoma, stage IV melanoma, recurrent melanoma
- 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 alfaBiological
radiation therapyRadiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2004 (estimated)
- Study start29 Mar 1999
- Primary completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Enrolment
- 167 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Maury M. Rosenstein, MD, Study chair, UPMC Cancer Center at UPMC St. Margaret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003444
- Sponsor's protocol ID
- CDR0000066472
- Other IDs
- E-3697
- Status last verified
- Jun 2023
- First submitted
- 1 Nov 1999
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Phase III Clinical Trial Assessing the Role of Post-Operative Radiotherapy Plus Adjuvant Interferon Alpha-2b in Patients With Cervical, Axillary, and Inguinal Nodal Metastasis From Cutaneous Melanoma
- ClinicalTrials.gov ID
- NCT00003444
- Acronym / sponsor ID
- CDR0000066472
- Conditions
- Melanoma (Skin)
- Keywords
- stage III melanoma, stage IV melanoma, recurrent melanoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (estimated)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 29 Mar 1999 (actual)
- Primary completion
- Sep 2003 (actual)
- First posted
- 24 May 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Interferon alfa-2b may interfere with the growth of cancer cells. It is not yet known whether giving radiation therapy with interferon alfa-2b is more effective than giving interferon alfa-2b alone in treating melanoma.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus interferon alfa-2b with that of interferon alfa-2b alone in treating patients who have melanoma that has metastasized to lymph nodes in the neck, under the arm, or in the groin.
Detailed description
OBJECTIVES: I. Evaluate the effectiveness of postoperative hypofractionated radiotherapy in combination with high dose interferon in preventing regional relapse in patients with malignant melanoma with any number of nodes with clinical extracapsular extension or previous nodal basin recurrence. II. Evaluate the effectiveness of this therapy in prolonging relapse free and overall survival in this patient population. III. Evaluate the toxicity of this therapy in this patient population.
OUTLINE: This is a randomized study. Patients are stratified according to prior nodal basin recurrence, site of disease, and extracapsular extension. Following surgery, patients are randomized to receive either interferon alfa-2b alone or five treatments of radiotherapy followed by interferon alfa-2b. Patients receive radiotherapy 2 days a week for 2.5 weeks. Patients receive interferon alfa-2b IV over 20 minutes daily for 5 days for a total of 28 days, followed by subcutaneous injections 3 times a week for 48 weeks. Patients are followed every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter.
PROJECTED ACCRUAL: Approximately 167 patients will be accrued for this study within 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant interferon alfa | Biological | – |
| radiation therapy | Radiation | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maury M. Rosenstein, MD study chair
UPMC Cancer Center at UPMC St. Margaret
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing recombinant interferon alfa and radiation therapy in people with Melanoma (Skin), run by Eastern Cooperative Oncology Group at 23 sites 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?
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: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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 22 Jun 2023.