High-dose ICE With Amifostine (NCT00003657) | Clinical Trial Compass
CompletedPhase 2
High-dose ICE With Amifostine
United States24 participantsStarted 1998-07
Plain-language summary
The purpose of the study is to evaluate the combination of amifostine and high dose chemotherapy with blood stem cell support. Amifostine is a druf developed to protect normal tissues against the toxicities of chemotherapy and radiotherapy and has reduced the side effects of chemotherapy given at conventional doses.
Who can participate
Age range
18 Years – 55 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.
Eligibility Criteria:
* Histologically documented malignancy
* Metastatic or locally unresectable malignancy
* Patient may be responding to therapy
* Responding Stage IIIC/IV or recurrent/refractory ovarian carcinoma (ineligible for other bone marrow or stem cell transplant protocols)
* Relapsed germ cell carcinomas
* Relapsed lymphomas (ineligible for other BMT or SCT protocols
* SCLC in PR or CR
* Sarcomas in or near complete remission after induction chemotherapy
* Stage IIIB NSCLC responding to chemotherapy
* Responsive bladder, head and neck carcinoma, or carcinoma of unknown primary
* Other tumors without curative or first line therapy (not eligible for phase II or III studies)
* Aged 18 to 55 Physiologic years
\-- Performance status: PS 0-1
* Prior Treatment
* \> 1 week since surgery or RT
* \> 3 weeks since prior CT
* Informed Consent
* Required initial laboratory data:
* White Cell Count Life ≥ 3000/ul
* Platelet Count ≥ 100,000/ul
* Creatinine ≤ 1.5 x normal
* Bilirubin ≤ 1.5 x normal
* No current metastases
* BM Asp \& Bx
* Brain CAT
* Creatinine Clearance ≥ 60 cc/min
* SGOT \< 2.5 x normal
* No other serious medical or psychiatric illness which would prevent informed consent or general anesthesia
* Uncontrolled or severe cardiovascular disease including recent (\< 6 months) myocardial infarction, or congestive heart failure
* Active uncontrolled bacterial, viral, or fungal infection; or an active duodenal ulce…
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
Percentage of Participants with Grade 2 or higher renal toxicities