High Dose Ifosfamide, Carboplatin and Etoposide With Amifostine Chemoprotection
Acronym
Not provided
Organization
Dana-Farber Cancer InstituteOTHER
Status Module
Record Verification Date
Jan 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 1998
Primary Completion Date
Nov 2000Actual
Completion Date
Jun 2002Actual
First Submitted Date
Nov 1, 1999
First Submission Date that Met QC Criteria
Mar 30, 2004
First Posted Date
Mar 31, 2004Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 19, 2017
Last Update Posted Date
Jan 20, 2017Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Paul G. Richardson, MD, Richardson, Paul MD, Dana-Farber Cancer InstitutePrincipal Investigator
Lead Sponsor
Dana-Farber Cancer InstituteOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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 provided
Conditions Module
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
Unspecified Adult Solid Tumor, Protocol Specific
Keywords
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
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
24Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
High Dose ICF with Amifostine
Experimental
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.
Percentage of Participants with Grade 2 or higher renal toxicities
2 Months
Secondary Outcomes
Measure
Description
Time Frame
Full Pharmacokinetic profiles for ifosfamide and its metabolites MTD of ICE with amifostine
2 Months
Other Outcomes
Not provided
Eligibility Module
Eligibility 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
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
55 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Paul G.G. Richardson, MD
Dana-Farber Cancer Institute
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Massachusetts General Hospital Cancer Center
Boston
Massachusetts
02114
United States
Dana-Farber Cancer Institute
References Module
Citations
PubMed Identifier
Type
Citation
Retractions
Result
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.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
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
stage III verrucous carcinoma of the oral cavity
stage III mucoepidermoid carcinoma of the oral cavity
stage III adenoid cystic carcinoma of the oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV basal cell carcinoma of the lip
stage IV verrucous carcinoma of the oral cavity
stage IV mucoepidermoid carcinoma of the oral cavity
stage IV adenoid cystic carcinoma of the oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent basal cell carcinoma of the lip
recurrent verrucous carcinoma of the oral cavity
recurrent mucoepidermoid carcinoma of the oral cavity
recurrent adenoid cystic carcinoma of the oral cavity
stage III squamous cell carcinoma of the oropharynx
stage III lymphoepithelioma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
stage IV lymphoepithelioma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
recurrent lymphoepithelioma of the oropharynx
stage III squamous cell carcinoma of the nasopharynx
stage III lymphoepithelioma of the nasopharynx
stage IV squamous cell carcinoma of the nasopharynx
stage IV lymphoepithelioma of the nasopharynx
recurrent squamous cell carcinoma of the nasopharynx
recurrent lymphoepithelioma of the nasopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage III verrucous carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx
stage IV verrucous carcinoma of the larynx
recurrent squamous cell carcinoma of the larynx
recurrent verrucous carcinoma of the larynx
stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
stage III inverted papilloma of the paranasal sinus and nasal cavity
stage III midline lethal granuloma of the paranasal sinus and nasal cavity
stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity
stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
stage IV inverted papilloma of the paranasal sinus and nasal cavity
stage IV midline lethal granuloma of the paranasal sinus and nasal cavity
stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent inverted papilloma of the paranasal sinus and nasal cavity
recurrent midline lethal granuloma of the paranasal sinus and nasal cavity
recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity