Phase II study with ifosfamide in advanced malignant melanoma

Area of Science:

• Medical Oncology
• Clinical Pharmacology
• Dermatology

Background:

• Advanced malignant melanoma is a significant clinical challenge.
• Chemotherapy remains a treatment option for metastatic disease.
• Ifosfamide is an alkylating agent with activity in various cancers.

Purpose of the Study:

• To evaluate the efficacy and safety of ifosfamide in patients with advanced malignant melanoma.
• To determine if ifosfamide has a therapeutic role in this patient population.

Main Methods:

• A phase II clinical trial was conducted.
• 12 evaluable patients with advanced malignant melanoma were enrolled.
• Ifosfamide was administered at 3 g/m2 on days 1 and 2 every 3 weeks.

Main Results:

• No objective tumor response was observed in any patient.
• Mild vomiting occurred in 75% of patients, and alopecia in all patients.
• No significant myelotoxicity or urotoxicity was noted.

Conclusions:

• Ifosfamide, at the tested dose and schedule, demonstrated no efficacy in advanced malignant melanoma.
• The study data do not support the use of ifosfamide for metastatic malignant melanoma.
• Further investigation of ifosfamide in this indication is not warranted.