Conditions: Adult Central Nervous System Germ Cell Tumor Adult Teratoma Malignant Extragonadal Germ Cell Tumor Malignant Extragonadal Non-Seminomatous Germ Cell Tumor Extragonadal Seminoma Recurrent Malignant Testicular Germ Cell Tumor Recurrent Ovarian Germ Cell Tumor Stage IV Extragonadal Non-Seminomatous Germ Cell Tumor Stage IV Extragonadal Seminoma Stage IV Ovarian Germ Cell Tumor
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 5
Healthy volunteers: no

Brief summary:
This phase II trial studies how well palifosfamide works in treating patients with recurrent germ cell tumors. Drugs used in chemotherapy, such as palifosfamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the response rate (complete response \[CR\]+partial response \[PR\]) of single agent palifosfamide in patients with refractory germ cell tumors.

SECONDARY OBJECTIVES:

I. To determine the duration of remission. II. To determine progression free and overall survival. III. To assess toxicity and tolerability of palifosfamide in patients with germ cell tumors.

OUTLINE:

Patients receive palifosfamide intravenously (IV) over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

Arms:
arm 1: Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Interventions: intervention 1: palifosfamide
Intervention descriptions: intervention 1: Given IV

Protocol document: