Melanoma (Skin)Phase 2NCT00049530
PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma
A Phase 2 study testing PEG-interferon alfa-2b in people with Melanoma (Skin), run by Eastern Cooperative Oncology Group at 32 sites in United States.
Trial summary
RATIONALE: Peginterferon (PEG-interferon) alfa-2b may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have stage IV melanoma. 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?
- PEG-interferon alfa-2b
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 32 sitesUnited States
- Study dates
- 13 Jan 2004to Jun 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed stage IV melanoma
- Stage M1a, M1b, or M1c
- Mucosal, ocular, or unknown primary melanoma
- Previously untreated OR received up to 3 prior systemic therapy regimens (excluding vaccine therapy) for metastatic disease
- Plasma basic fibroblast growth factor level at least 15 pg/mL
- Measurable or evaluable disease
Show all 25Show fewer
- Central nervous system (CNS) involvement allowed provided CNS directed therapy has been given and disease has been clinically stable for ≥ 3 months
- Brain computed tomography (CT) scan or Magnetic resonance imaging (MRI) to confirm stable disease required ≤ 4 weeks prior to study entry
- Age: 18 and over
- ECOG Performance status of 0-2
- Life expectancy at least 6 months
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8 g/dL (transfusions allowed)
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- Alanine Aminotransferase (ALT) no greater than 2 times ULN
- Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min
- At least 4 weeks since prior interferon in the adjuvant or metastatic setting
- At least 4 weeks since prior chemotherapy in the adjuvant or metastatic setting
- At least 4 weeks since prior endocrine therapy in the adjuvant or metastatic setting
- At least 4 weeks since prior radiotherapy in the adjuvant or metastatic setting
- At least 4 weeks since prior surgery in the adjuvant or metastatic setting
- At least 4 weeks since other prior therapy in the adjuvant or metastatic setting
- Negative pregnancy test
- Fertile patients must use effective contraception
Who cannot join
- Myocardial infarction within the past 6 months
- Other active malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- Other concurrent illness that would preclude study participation
- History of severe depression
- Pregnant or nursing
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, 44309-2090
UAB Comprehensive Cancer Center
Birmingham, Alabama, 35294
St. Joseph Medical Center
Bloomington, Illinois, 61701
Graham Hospital
Canton, Illinois, 61520
Aultman Cancer Center at Aultman Hospital
Canton, Ohio, 44710-1799
Memorial Hospital
Carthage, Illinois, 62321
West Virginia University Health Sciences Center - Charleston
Charleston, West Virginia, 25304
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, 44109
Decatur Memorial Hospital Cancer Care Institute
Decatur, Illinois, 62526
Eureka Community Hospital
Eureka, Illinois, 61530
Galesburg Clinic, PC
Galesburg, Illinois, 61401
Mason District Hospital
Havana, Illinois, 62644
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, 60521
Borgess Medical Center
Kalamazoo, Michigan, 49001
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Gundersen Lutheran Center for Cancer and Blood
La Crosse, Wisconsin, 54601
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, 33805
McDonough District Hospital
Macomb, Illinois, 61455
BroMenn Regional Medical Center
Normal, Illinois, 61761
Community Cancer Center
Normal, Illinois, 61761
Community Hospital of Ottawa
Ottawa, Illinois, 61350
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, 61554
Proctor Hospital
Peoria, Illinois, 61614
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61615
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, 61615
Methodist Medical Center of Illinois
Peoria, Illinois, 61636
OSF St. Francis Medical Center
Peoria, Illinois, 61637
Illinois Valley Community Hospital
Peru, Illinois, 61354
UPMC Cancer Centers
Pittsburgh, Pennsylvania, 15232
Perry Memorial Hospital
Princeton, Illinois, 61356
Swedish-American Regional Cancer Center
Rockford, Illinois, 61104-2315
About this study
Official title: Phase II Study of Low Dose Peginterferon Alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor
RATIONALE: Peginterferon (PEG-interferon) alfa-2b may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have stage IV melanoma.
Read the detailed description
OBJECTIVES:
- Determine the ability of low-dose PEG-interferon alfa-2b to suppress plasma basic fibroblast growth factor (b-FGF) levels to normal in patients with metastatic melanoma over-expressing b-FGF.
- Determine the antitumor effect of this drug, in terms of progression-free and overall survival and tumor response, in these patients.
- Correlate tumor activity of this drug with b-FGF and vascular endothelial growth factor levels in the plasma and urine of these patients.
- Determine the safety profile of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 2 years.
- Conditions
- Melanoma (Skin)
- Being tested
- PEG-interferon alfa-2b
- Keywords
- recurrent melanoma, stage IV melanoma
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEG-interferon alfa-2bBiological
Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| PEG-interferon alfa-2b | Experimental | Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity. Receives: Biological: PEG-interferon alfa-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma b-FGF Level Response
The primary endpoint was the suppression of plasma b-FGF level with low dose peginterferon alfa-2b. A clinically important reduction of plasma b-FGF levels was determined to be a level less than or equal to 7.5 pg/mL. A patient was considered to have a suppressed plasma b-FGF level, if the patient experienced the clinically significant reduction (less than or equal to 7.5 pg/mL) of plasma b-FGF levels for two consecutive determinations which were at least three weeks apart. This was considered as a b-FGF response.
Measured: assessed every 3 weeks until the suppression of plasma b-FGF level to normal, then every 6 weeks until the completion of 12 months of treatment, and upon treatment discontinuation
Secondary outcomes (3)
Non-progression Rate (Clinical Response to Peginterferon Alfa-2b)
Objective tumor response was assessed using RECIST (Response Evaluation Criteria in Solid Tumors) 1.0 criteria. Per RECIST criteria, complete response (CR) = disappearance of all target and non-target lesions. Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Progression is defined as at least 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s) or unequivocal progression of existing non-target lesions. Stable disease (SD) = did not meet criteria for response or progression.
Non-progression rate = CR + PR + SD.
Measured: assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years
Progression Free Survival
Progression free survival (PFS) was defined as the time from registration to disease progression, or censored at last known date of non progressive disease.
Measured: assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years
Overall Survival
Overall survival (OS) time was defined as the time from registration to death from any cause, or censored at last known date of survival.
Measured: assessed every 3 months if <2 years, and every 6 months if 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study start13 Jan 2004
- Primary completionAug 2012
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Cooperative Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ronald S. Go, MD, Study chair, Gundersen Lutheran Center for Cancer and Blood
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00049530
- Sponsor's protocol ID
- CDR0000258114
- Other IDs
- E2602, U10CA021115
- Status last verified
- Jun 2023
- First submitted
- 12 Nov 2002
- Last updated
- 29 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Low Dose Peginterferon Alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor
- ClinicalTrials.gov ID
- NCT00049530
- Acronym / sponsor ID
- CDR0000258114
- Conditions
- Melanoma (Skin)
- Keywords
- recurrent melanoma, stage IV melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Eastern Cooperative Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 13 Jan 2004 (actual)
- Primary completion
- Aug 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Jan 2003 (estimated)
- Results
- Posted 3 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Peginterferon (PEG-interferon) alfa-2b may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of PEG-interferon alfa-2b in treating patients who have stage IV melanoma.
Detailed description
OBJECTIVES:
- Determine the ability of low-dose PEG-interferon alfa-2b to suppress plasma basic fibroblast growth factor (b-FGF) levels to normal in patients with metastatic melanoma over-expressing b-FGF.
- Determine the antitumor effect of this drug, in terms of progression-free and overall survival and tumor response, in these patients.
- Correlate tumor activity of this drug with b-FGF and vascular endothelial growth factor levels in the plasma and urine of these patients.
- Determine the safety profile of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study within 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PEG-interferon alfa-2b | Experimental | Biological: PEG-interferon alfa-2bPatients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Histologically confirmed stage IV melanoma
- Previously untreated OR received up to 3 prior systemic therapy regimens (excluding vaccine therapy) for metastatic disease
- Plasma basic fibroblast growth factor level at least 15 pg/mL
- Measurable or evaluable disease
- Central nervous system (CNS) involvement allowed provided CNS directed therapy has been given and disease has been clinically stable for ≥ 3 months
Key exclusion criteria (5 listed)
- Myocardial infarction within the past 6 months
- Other active malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- Other concurrent illness that would preclude study participation
- History of severe depression
- Pregnant or nursing
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 |
|---|---|---|
| PEG-interferon alfa-2bPatients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity. | Biological | PEG-interferon alfa-2b |
Primary outcome
Plasma b-FGF Level Response
Time frame: assessed every 3 weeks until the suppression of plasma b-FGF level to normal, then every 6 weeks until the completion of 12 months of treatment, and upon treatment discontinuation
The primary endpoint was the suppression of plasma b-FGF level with low dose peginterferon alfa-2b. A clinically important reduction of plasma b-FGF levels was determined to be a level less than or equal to 7.5 pg/mL. A patient was considered to have a suppressed plasma b-FGF level, if the patient experienced the clinically significant reduction (less than or equal to 7.5 pg/mL) of plasma b-FGF levels for two consecutive determinations which were at least three weeks apart. This was considered as a b-FGF response.
3 secondary outcomes
Non-progression Rate (Clinical Response to Peginterferon Alfa-2b)
Time frame: assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years
Progression Free Survival
Time frame: assessed every 9 weeks until suppression of plasma b-FGF level to normal, every 12 weeks until the completion of 12 months of treatment, >= 4 weeks after documented response. After off treatment, every 3 months if <2 years, and every 6 months if 2-3 years
Overall Survival
Time frame: assessed every 3 months if <2 years, and every 6 months if 2-3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Melanoma (Skin)
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
Ronald S. Go, MD study chair
Gundersen Lutheran Center for Cancer and Blood
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PEG-interferon alfa-2b in people with Melanoma (Skin), run by Eastern Cooperative Oncology Group at 32 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?
The sponsor lists 25 inclusion and 5 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: finished, as of the sponsor's last update on 29 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 32 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Plasma b-FGF Level Response (time frame: assessed every 3 weeks until the suppression of plasma b-FGF level to normal, then every 6 weeks until the completion of 12 months of treatment, and upon treatment discontinuation). It is what the study was designed to measure, not a finding.
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 29 Jun 2023.