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High-dose ICE With Amifostine

Primary Purpose

Bladder Cancer, Brain and Central Nervous System Tumors, Carcinoma of Unknown Primary

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
filgrastim
Amifostine
Carboplatin
Etoposide
Ifosfamide
peripheral blood stem cell transplantation
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring 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, 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, extragonadal germ cell tumor, newly diagnosed carcinoma of unknown primary, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, borderline ovarian surface epithelial-stromal tumor, recurrent carcinoma of unknown primary, ovarian sarcoma, adult central nervous system germ cell tumor, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, clear cell sarcoma of the kidney, stage IV adult soft tissue sarcoma

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital Cancer Center
  • Dana-Farber Cancer Institute
  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

High Dose ICF with Amifostine

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Participants with Grade 2 or higher renal toxicities

Secondary Outcome Measures

Full Pharmacokinetic profiles for ifosfamide and its metabolites MTD of ICE with amifostine

Full Information

First Posted
November 1, 1999
Last Updated
January 19, 2017
Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003657
Brief Title
High-dose ICE With Amifostine
Official Title
High Dose Ifosfamide, Carboplatin and Etoposide With Amifostine Chemoprotection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 1998 (undefined)
Primary Completion Date
November 2000 (Actual)
Study Completion Date
June 2002 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, 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, extragonadal germ cell tumor, newly diagnosed carcinoma of unknown primary, stage III uterine sarcoma, stage IV uterine sarcoma, recurrent uterine sarcoma, borderline ovarian surface epithelial-stromal tumor, recurrent carcinoma of unknown primary, ovarian sarcoma, adult central nervous system germ cell tumor, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor, clear cell sarcoma of the kidney, stage IV adult soft tissue sarcoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High Dose ICF with Amifostine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Type
Drug
Intervention Name(s)
Amifostine
Other Intervention Name(s)
Ethyol®
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Other Intervention Name(s)
Paraplatin
Intervention Type
Drug
Intervention Name(s)
Etoposide
Other Intervention Name(s)
Toposar, VePesid, Etopophos
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Other Intervention Name(s)
Ifex
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation
Primary Outcome Measure Information:
Title
Percentage of Participants with Grade 2 or higher renal toxicities
Time Frame
2 Months
Secondary Outcome Measure Information:
Title
Full Pharmacokinetic profiles for ifosfamide and its metabolites MTD of ICE with amifostine
Time Frame
2 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul G.G. Richardson, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
result

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High-dose ICE With Amifostine

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