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High-dose ICE With Amifostine

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Paul G. Richardson, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00003657
First received: November 1, 1999
Last updated: January 19, 2017
Last verified: January 2017
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: High Dose Ifosfamide, Carboplatin and Etoposide With Amifostine Chemoprotection

Resource links provided by NLM:


Further study details as provided by Paul G. Richardson, MD, Dana-Farber Cancer Institute:

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

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

Enrollment: 24
Study Start Date: July 1998
Study Completion Date: June 2002
Primary Completion Date: November 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003657

Locations
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)
Investigators
Principal Investigator: Paul G.G. Richardson, MD Dana-Farber Cancer Institute
  More Information

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.

Responsible Party: Paul G. Richardson, MD, Richardson, Paul MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00003657     History of Changes
Other Study ID Numbers: 98-068
P30CA006516 ( US NIH Grant/Contract Award Number )
DFCI-98068
ALZA-97-038-ii
NCI-V98-1491
Study First Received: November 1, 1999
Last Updated: January 19, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Paul G. Richardson, MD, Dana-Farber Cancer Institute:
metastatic osteosarcoma
recurrent non-small cell lung cancer
chondrosarcoma
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:
Carcinoma
Neoplasms
Lung Neoplasms
Sarcoma
Head and Neck Neoplasms
Urinary Bladder Neoplasms
Neoplasms, Germ Cell and Embryonal
Kidney Neoplasms
Carcinoma, Renal Cell
Nervous System Neoplasms
Central Nervous System Neoplasms
Testicular 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
Urologic Neoplasms
Urogenital Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Kidney Diseases
Adenocarcinoma
Nervous System Diseases
Endocrine Gland Neoplasms
Genital Neoplasms, Male

ClinicalTrials.gov processed this record on June 22, 2017