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Published on: July 31, 2016
Phase II trial of pegylated interferon and thalidomide in malignant metastatic melanoma
Ulka N Vaishampayan1, Lance K Heilbrun, Cynthia Marsack
1Division of Oncology, Department of Medicine, Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, Michigan, USA. vaishamu@karmanos.org
Abstract:
Pegylated interferon and thalidomide demonstrate immunomodulatory and antiangiogenic activity, and efficacy in melanoma. The combination was evaluated in a phase II trial. Eligibility included biopsy-confirmed malignant melanoma with metastases and progression, maximum of two earlier systemic therapies, performance status of 0-2, and adequate hepatic, bone marrow and renal function. Pegylated interferon was administered at a dose of 0.5 microg/kg subcutaneously weekly and thalidomide 200 mg orally daily. Toxicity was evaluated every 2 weeks and response every 8 weeks. Eighteen patients were enrolled in this trial. Median age was 55.5 years (range: 29-80 years). Seventeen patients had visceral metastases and one had lymph node-only metastases. Two patients had brain metastases. Nine patients had received earlier adjuvant therapy and 16 patients had received earlier therapy for metastatic disease. Performance status was 0, 1 and 2 in 11, six and one patients, respectively. Severe (grade 4) toxicities observed were anemia in two patients and thrombocytopenia in one patient. No treatment-related deaths occurred. Dose escalation of thalidomide to 300 mg daily was feasible in four patients. One therapy-related hospitalization for nausea and dehydration occurred. No objective responses were noted; three patients demonstrated disease stabilization. The regimen of pegylated interferon and thalidomide was well tolerated. The combination, however, failed to demonstrate clinical efficacy in pretreated metastatic malignant melanoma.
Insights
This phase II trial found that combining pegylated interferon with thalidomide was well-tolerated in patients with metastatic melanoma. However, the combination did not show significant clinical efficacy in this pretreated patient group.
Area of Science:
- Oncology
- Immunology
- Pharmacology
Background:
- Pegylated interferon and thalidomide possess immunomodulatory and antiangiogenic properties.
- Previous studies indicated potential efficacy of these agents in melanoma treatment.
Purpose of the Study:
- To evaluate the safety and efficacy of combining pegylated interferon and thalidomide in patients with metastatic malignant melanoma.
Main Methods:
- A phase II clinical trial enrolled 18 patients with biopsy-confirmed metastatic melanoma and disease progression.
- Patients received pegylated interferon 0.5 microg/kg subcutaneously weekly and thalidomide 200 mg orally daily.
- Toxicity and response were assessed regularly, with feasibility of dose escalation to 300 mg thalidomide daily explored.
Main Results:
- The combination regimen was generally well-tolerated, with grade 4 toxicities including anemia and thrombocytopenia.
- Dose escalation of thalidomide was feasible in a subset of patients.
- No objective responses were observed; three patients achieved disease stabilization.
Conclusions:
- The combination of pegylated interferon and thalidomide is a safe and tolerable option for pretreated metastatic melanoma.
- This regimen failed to demonstrate significant clinical efficacy in the studied patient population.
