High-dose ICE With Amifostine

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedfilgrastim and Amifostine

Plus 4 other study approaches.

Who it may be forBladder Cancer · Brain and Central Nervous System Tumors

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Dana-Farber Cancer Institute

Study sponsor

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

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How this study is categorized

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

Treatment approach

Chemotherapy→Radiation therapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

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

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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