Phase 2
N=32
PEG-Interferon Alfa-2b in Treating Patients With Stage IV Melanoma
Melanoma (Skin)
Bottom Line
View on ClinicalTrials.gov: NCT00049530 ↗Enrolled (actual)
32
Serious AEs
40.6%
Results posted
Jun 2014
Primary outcome: Primary: Plasma b-FGF Level Response — 34.5 percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PEG-interferon alfa-2b (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eastern Cooperative Oncology Group
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma b-FGF Level Response |
34.5 | <0.001 sig |
| SECONDARY Non-progression Rate (Clinical Response to Peginterferon Alfa-2b) |
24.1 | — |
| SECONDARY Progression Free Survival |
2 | — |
| SECONDARY Overall Survival |
9.7 | — |
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.
Eligibility Criteria
Inclusion criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT00049530). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.