Palifosfamide in Treating Patients With Recurrent Germ Cell Tumors (NCT01808534) | Clinical Trial Compass
TerminatedPhase 2
Palifosfamide in Treating Patients With Recurrent Germ Cell Tumors
Stopped: Due to Low Accrual
United States5 participantsStarted 2013-02
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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 provi…
What they're measuring
1
Overall Response Rate (Defined as Partial Response or Complete Response)