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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Overall Response Rate (Defined as Partial Response or Complete Response)