PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma
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| ClinicalTrials.gov Identifier: NCT00049530 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Results First Posted : June 3, 2014
Last Update Posted : October 28, 2015
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Melanoma (Skin) | Biological: PEG-interferon alfa-2b | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 32 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase II Study of Low Dose Peginterferon Alfa-2b in Patients With Metastatic Melanoma Over-Expressing Basic Fibroblast Growth Factor |
| Study Start Date : | September 2003 |
| Actual Primary Completion Date : | August 2012 |
| Actual Study Completion Date : | June 2014 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: PEG-interferon alfa-2b
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.
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Biological: PEG-interferon alfa-2b
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. |
- 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.
- 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 ]
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.
- 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 ]Progression free survival (PFS) was defined as the time from registration to disease progression, or censored at last known date of non progressive disease.
- Overall Survival [ Time Frame: assessed every 3 months if <2 years, and every 6 months if 2-3 years ]Overall survival (OS) time was defined as the time from registration to death from any cause, or censored at last known date of survival.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
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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
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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
Exclusion criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00049530
| United States, Alabama | |
| UAB Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Florida | |
| Lakeland Regional Cancer Center at Lakeland Regional Medical Center | |
| Lakeland, Florida, United States, 33805 | |
| United States, Illinois | |
| St. Joseph Medical Center | |
| Bloomington, Illinois, United States, 61701 | |
| Graham Hospital | |
| Canton, Illinois, United States, 61520 | |
| Memorial Hospital | |
| Carthage, Illinois, United States, 62321 | |
| Decatur Memorial Hospital Cancer Care Institute | |
| Decatur, Illinois, United States, 62526 | |
| Eureka Community Hospital | |
| Eureka, Illinois, United States, 61530 | |
| Galesburg Clinic, PC | |
| Galesburg, Illinois, United States, 61401 | |
| Mason District Hospital | |
| Havana, Illinois, United States, 62644 | |
| Hinsdale Hematology Oncology Associates | |
| Hinsdale, Illinois, United States, 60521 | |
| McDonough District Hospital | |
| Macomb, Illinois, United States, 61455 | |
| BroMenn Regional Medical Center | |
| Normal, Illinois, United States, 61761 | |
| Community Cancer Center | |
| Normal, Illinois, United States, 61761 | |
| Community Hospital of Ottawa | |
| Ottawa, Illinois, United States, 61350 | |
| Cancer Treatment Center at Pekin Hospital | |
| Pekin, Illinois, United States, 61554 | |
| Proctor Hospital | |
| Peoria, Illinois, United States, 61614 | |
| CCOP - Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61615 | |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | |
| Peoria, Illinois, United States, 61615 | |
| Methodist Medical Center of Illinois | |
| Peoria, Illinois, United States, 61636 | |
| OSF St. Francis Medical Center | |
| Peoria, Illinois, United States, 61637 | |
| Illinois Valley Community Hospital | |
| Peru, Illinois, United States, 61354 | |
| Perry Memorial Hospital | |
| Princeton, Illinois, United States, 61356 | |
| Swedish-American Regional Cancer Center | |
| Rockford, Illinois, United States, 61104-2315 | |
| United States, Michigan | |
| Borgess Medical Center | |
| Kalamazoo, Michigan, United States, 49001 | |
| West Michigan Cancer Center | |
| Kalamazoo, Michigan, United States, 49007-3731 | |
| Bronson Methodist Hospital | |
| Kalamazoo, Michigan, United States, 49007 | |
| United States, Ohio | |
| Summa Center for Cancer Care at Akron City Hospital | |
| Akron, Ohio, United States, 44309-2090 | |
| Aultman Cancer Center at Aultman Hospital | |
| Canton, Ohio, United States, 44710-1799 | |
| MetroHealth Cancer Care Center at MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| United States, Pennsylvania | |
| UPMC Cancer Centers | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, West Virginia | |
| West Virginia University Health Sciences Center - Charleston | |
| Charleston, West Virginia, United States, 25304 | |
| United States, Wisconsin | |
| Gundersen Lutheran Center for Cancer and Blood | |
| La Crosse, Wisconsin, United States, 54601 | |
| Study Chair: | Ronald S. Go, MD | Gundersen Lutheran Center for Cancer and Blood |
| Responsible Party: | Eastern Cooperative Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00049530 History of Changes |
| Other Study ID Numbers: |
CDR0000258114 E2602 ( Other Identifier: Eastern Cooperative Oncology Group ) U10CA021115 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 27, 2003 Key Record Dates |
| Results First Posted: | June 3, 2014 |
| Last Update Posted: | October 28, 2015 |
| Last Verified: | May 2014 |
Keywords provided by Eastern Cooperative Oncology Group:
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recurrent melanoma stage IV melanoma |
Additional relevant MeSH terms:
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Melanoma Nevi and Melanomas Interferons Interferon-alpha Peginterferon alfa-2b Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Mitogens Antineoplastic Agents Antiviral Agents Anti-Infective Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |