Overview

High-dose ICE With Amifostine

Status:
Completed
Trial end date:
2002-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborator:
National Cancer Institute (NCI)
Treatments:
Amifostine
Carboplatin
Etoposide
Etoposide phosphate
Ifosfamide
Isophosphamide mustard
Criteria
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
ulcer; until these conditions are corrected or controlled

- Pregnancy

- Unable to stop taking antihypertensive medication 24 hours prior to
administration of Ethyol