Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors (NCT00003926) | Clinical Trial Compass
TerminatedPhase 1
Amifostine to Protect From Side Effects of PSCT in Treating Patients With Solid Tumors
Stopped: Withdrawn due to slow accrual
United States13 participantsStarted 1998-11
Plain-language summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of high-dose chemotherapy.
PURPOSE: Phase I trial to study the effectiveness of amifostine in protecting from the side effects of peripheral stem cell transplantation in treating patients who have high-risk or relapsed solid tumors.
Who can participate
Age range
1 Year – 45 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:
* Histologically confirmed high-risk or relapsed solid tumors or brain tumors, including:
* Metastatic or relapsed Ewing's sarcoma
* Metastatic or relapsed rhabdomyosarcoma
* Refractory Wilms' tumor
* Diffuse anaplastic Wilms' tumor
* Stage III or IV neuroblastoma
* Recurrent retinoblastoma
* Metastatic or relapsed germ cell tumors
* Metastatic or relapsed other soft tissue sarcomas
* Small cell ovarian sarcoma
* Metastatic or relapsed primitive neuroectodermal tumors of the bone
* Recurrent brain tumors
* Desmoplastic small round cell tumors
* Recurrent or metastatic chordomas
* Metastatic or relapsed hepatoblastoma
* Patients receive peripheral blood stem cell transplantation only if in complete remission or in very good partial remission with no disease progression
* Must have radiologic, nuclear image, or histologic verification of relapse
* Age 1 to 45
* Performance status:Karnofsky 70-100%
* Absolute neutrophil count greater than 1,000/mm\^3
* Platelet count greater than 100,000/mm\^3
* Hemoglobin count at least 10 g/dL
* Bilirubin less than 2 times upper limit of normal (ULN)
* SGOT or SGPT less than 2.5 times ULN
* Creatinine less than 2 times ULN
* Creatinine clearance greater than 70 mL/min
* Cardiac shortening fraction greater than 30%
* Cardiac ejection fraction greater than 45%
* At least 1 week since prior hematopoietic growth factor and recovered
* At least 3 weeks since prior chemotherapy (6 weeks for nitrosour…
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.
Trial details
NCT IDNCT00003926
SponsorMasonic Cancer Center, University of Minnesota