Palifosfamide in Treating Patients With Recurrent Germ Cell Tumors

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.

Inclusion Criteria:

- Patients must have histological or serological proof of metastatic germ cell neoplasm
(gonadal or extragonadal primary) with disease not amenable to cure with either
surgery or chemotherapy; patients with seminoma and nonseminoma are eligible, as are
women with ovarian germ cell tumors

- Patients must have evidence of recurrent or metastatic carcinoma by one or more of
the criteria specified in the protocol

- Patients must have received initial cisplatin based combination therapy (such as
bleomycin, etoposide and cisplatin [BEP], etoposide and cisplatin [EP], VP-16 plus
ifosfamide plus cisplatin [VIP] or similar regimens) AND demonstrated progression
following the administration of at least one 'salvage' regimen for advanced germ cell
neoplasm (such as high dose chemotherapy, paclitaxel/ifosfamide/cisplatin [TIP] or
vinblastine, ifosfamide and cisplatin [VeIP])

- Patients must have documented "failure" of prior therapy as defined in the protocol

- Patients are eligible after first line platinum based chemotherapy if their disease
has relapsed and they have primary mediastinal non seminomatous germ cell tumor
(PMNSGCT) or late relapse (> 2 years) not amenable to surgical resection

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Laboratory test results must be within ranges established in the protocol

- Potential subject must have the ability to understand (as judged by the treating
physician) and willingness to provide written informed consent and Health Insurance
Portability and Accountability Act (HIPAA) authorization for release of personal
health information;

- Females of childbearing potential must not be pregnant or breast-feeding; male and
female patients of reproductive potential must agree to use a highly reliable method
of birth control from the screening visit through 28 days after the last dose of
study drug

Exclusion Criteria:

- No active clinically serious infections as judged by the treating investigator (>
CTCAE grade 2) including known human immunodeficiency virus (HIV) infection or
chronic active hepatitis B or active hepatitis C

- No presence of, or history of any illness or injury to the urinary tract which may
make the patient more susceptible to acute renal insufficiency in the case of
potential renal adverse events

- Patients must not have any cardiac disorders as defined in the protocol

- No history of psychiatric illness/social situations that would limit compliance with
study requirements

- Patients must be at least 4 weeks post major surgery or significant traumatic injury
at time of study registration

- Patients must be at least 7 days post any minor surgical procedure, excluding
placement of a vascular access device at the time of study registration

- Patients must not have a known sensitivity to any component of palifosfamide or its
known excipients

- Patients with active central nervous system (CNS) metastases are excluded

- Patients must not have previously been exposed to palifosfamide

- Patients must have at least 3 weeks after previous radiotherapy or chemotherapy and
have recovered from all major toxicities (except alopecia or grade 1 or 2 neuropathy)
at the time of registration