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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

November 1, 1999
January 19, 2017
July 1998
November 2000   (Final data collection date for primary outcome measure)
Percentage of Participants with Grade 2 or higher renal toxicities [ Time Frame: 2 Months ]
Not Provided
Complete list of historical versions of study NCT00003657 on ClinicalTrials.gov Archive Site
Full Pharmacokinetic profiles for ifosfamide and its metabolites MTD of ICE with amifostine [ Time Frame: 2 Months ]
Not Provided
Not Provided
Not Provided
 
High-dose ICE With Amifostine
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.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
  • 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
    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
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.
Interventions:
  • Biological: filgrastim
  • Drug: Amifostine
  • Drug: Carboplatin
  • Drug: Etoposide
  • Drug: Ifosfamide
  • Procedure: peripheral blood stem cell transplantation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
June 2002
November 2000   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00003657
98-068, P30CA006516, DFCI-98068, ALZA-97-038-ii, NCI-V98-1491
Yes
Not Provided
No
Not Provided
Paul G. Richardson, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Paul G.G. Richardson, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP