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 range18 Years – 55 Years
SexALL
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…
What they're measuring
1
Percentage of Participants with Grade 2 or higher renal toxicities