High-dose ICE With Amifostine

January 19, 2017 updated by: Paul G. Richardson, MD, Dana-Farber Cancer Institute

High Dose Ifosfamide, Carboplatin and Etoposide With Amifostine Chemoprotection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High Dose ICF with Amifostine
  • Patients undergo peripheral blood stem cell transplantation (PBSC) harvest on day -8,
  • ifosfamide IV, carboplatin IV etoposide IV (ICE) by 96 hour continuous infusion on days -7 to -4.
  • Patients receive amifostine IV twice a day on days -7 to -3.
  • PBSCs are reinfused on day 0.
  • Filgrastim (G-CSF) is administered subcutaneously beginning on day 0 at least 2 hours after infusion of the stem cells and continuing until blood cell counts recover.
  • Patients are followed monthly for the first 2 months and then for survival.
Procedure: peripheral blood stem cell transplantation
Biological: filgrastim
Drug: Carboplatin
Other Names:
  • Paraplatin
Drug: Ifosfamide
Other Names:
  • Ifex
Drug: Etoposide
Other Names:
  • Toposar
  • Etopophos
  • VePesid
Drug: Amifostine
Other Names:
  • Ethyol®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants with Grade 2 or higher renal toxicities
Time Frame: 2 Months
2 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Full Pharmacokinetic profiles for ifosfamide and its metabolites MTD of ICE with amifostine
Time Frame: 2 Months
2 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Paul G.G. Richardson, MD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Elias AD, Richardson P, Tretyakov O, et al.: Amifostine with high dose infosfamide, carboplatin, and etoposide (ICE) with hematopoietic STEM cell support. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A197, 2000.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 1998

Primary Completion (ACTUAL)

November 1, 2000

Study Completion (ACTUAL)

June 1, 2002

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

March 30, 2004

First Posted (ESTIMATE)

March 31, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

January 20, 2017

Last Update Submitted That Met QC Criteria

January 19, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-068
  • P30CA006516 (U.S. NIH Grant/Contract)
  • DFCI-98068
  • ALZA-97-038-ii
  • NCI-V98-1491

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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