Palifosfamide in Treating Patients With Recurrent Germ Cell Tumors
Condition: 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
MeSH terms: Neoplasms; Neoplasms, Germ Cell and Embryonal; Germinoma; Ovarian Neoplasms; Teratoma; Testicular Neoplasms; Seminoma; Recurrence
Intervention: palifosfamide
Intervention description: Given IV
Intervention MeSH terms: Isophosphamide mustard; Ifosfamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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
    

Eligibility criteria:

        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