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High-dose ICE With Amifostine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003657
Recruitment Status : Completed
First Posted : March 31, 2004
Last Update Posted : January 20, 2017
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Paul G. Richardson, MD, Dana-Farber Cancer Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Brain and Central Nervous System Tumors Carcinoma of Unknown Primary Extragonadal Germ Cell Tumor Head and Neck Cancer Kidney Cancer Lung Cancer Ovarian Cancer Sarcoma Testicular Germ Cell Tumor Unspecified Adult Solid Tumor, Protocol Specific Biological: filgrastim Drug: Amifostine Drug: Carboplatin Drug: Etoposide Drug: Ifosfamide Procedure: peripheral blood stem cell transplantation Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Dose Ifosfamide, Carboplatin and Etoposide With Amifostine Chemoprotection
Study Start Date : July 1998
Actual Primary Completion Date : November 2000
Actual Study Completion Date : June 2002

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.
Biological: filgrastim
Drug: Amifostine
Other Name: Ethyol®

Drug: Carboplatin
Other Name: Paraplatin

Drug: Etoposide
Other Names:
  • Toposar
  • VePesid
  • Etopophos

Drug: Ifosfamide
Other Name: Ifex

Procedure: peripheral blood stem cell transplantation

Primary Outcome Measures :
  1. Percentage of Participants with Grade 2 or higher renal toxicities [ Time Frame: 2 Months ]

Secondary Outcome Measures :
  1. Full Pharmacokinetic profiles for ifosfamide and its metabolites MTD of ICE with amifostine [ Time Frame: 2 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003657

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United States, Massachusetts
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
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Principal Investigator: Paul G.G. Richardson, MD Dana-Farber Cancer Institute

Publications of Results:
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.

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Responsible Party: Paul G. Richardson, MD, Richardson, Paul MD, Dana-Farber Cancer Institute Identifier: NCT00003657     History of Changes
Other Study ID Numbers: 98-068
P30CA006516 ( U.S. NIH Grant/Contract )
First Posted: March 31, 2004    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Paul G. Richardson, MD, Dana-Farber Cancer Institute:
metastatic osteosarcoma
recurrent non-small cell lung cancer
stage III adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
recurrent osteosarcoma
stage III bladder cancer
recurrent bladder cancer
stage IV bladder cancer
stage III malignant testicular germ cell tumor
recurrent malignant testicular germ cell tumor
stage IIIB non-small cell lung cancer
unspecified adult solid tumor, protocol specific
classic Kaposi sarcoma
immunosuppressive treatment related Kaposi sarcoma
AIDS-related Kaposi sarcoma
recurrent Kaposi sarcoma
untreated metastatic squamous neck cancer with occult primary
recurrent metastatic squamous neck cancer with occult primary
ovarian stromal cancer
stage III ovarian germ cell tumor
stage IV ovarian germ cell tumor
recurrent ovarian germ cell tumor
stage III squamous cell carcinoma of the lip and oral cavity
stage III basal cell carcinoma of the lip
Additional relevant MeSH terms:
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Lung Neoplasms
Head and Neck Neoplasms
Urinary Bladder Neoplasms
Neoplasms, Germ Cell and Embryonal
Nervous System Neoplasms
Central Nervous System Neoplasms
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Connective and Soft Tissue
Urogenital Neoplasms
Urologic Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Nervous System Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Etoposide phosphate