High-dose ICE With Amifostine

Phase 2

Completed

• Conditions: 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
• Interventions: Biological: filgrastim; Drug: Amifostine; Drug: Carboplatin; Drug: Etoposide; Drug: Ifosfamide; Procedure: peripheral blood stem cell transplantation

• Registration Number: NCT00003657
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-07
• Study First Submitted: 1999-11-01
• Primary Completion: 2000-11
• Study Completion: 2002-06
• Study First Submitted QC: 2004-03-30
• Study First Posted: 2004-03-31
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High Dose ICF with Amifostine	filgrastim	* 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.
High Dose ICF with Amifostine	peripheral blood stem cell transplantation	* 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.
High Dose ICF with Amifostine	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.
High Dose ICF with Amifostine	Ifosfamide	* 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.
High Dose ICF with Amifostine	Carboplatin	* 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.
High Dose ICF with Amifostine	Etoposide	* 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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Grade 2 or higher renal toxicities	2 Months

Secondary Outcome Measures

Name	Time	Method
Full Pharmacokinetic profiles for ifosfamide and its metabolites MTD of ICE with amifostine	2 Months

Trial Locations

Locations (3)

Massachusetts General Hospital Cancer Center; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States