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