CompletedPhase 2NCT00003657

High-dose ICE With Amifostine

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.

Checked against the public recordLast updated Jan 20, 2017 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations3
SponsorDana-Farber Cancer Institute
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Dana-Farber Cancer Institute
Interventions being studied
Biological: filgrastim; Drug: Amifostine; Drug: Carboplatin; Drug: Etoposide; Drug: Ifosfamide; Procedure: peripheral blood stem cell transplantation
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Massachusetts General Hospital Cancer CenterBoston, Massachusetts
  • Dana-Farber Cancer InstituteBoston, Massachusetts
  • Beth Israel Deaconess Medical CenterBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 20, 2017. Always confirm current availability with the study team.

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