Completed

High Dose Ifosfamide, Carboplatin and Etoposide With Amifostine Chemoprotection

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

filgrastim

+ Amifostine

+ Carboplatin

BiologicalDrugProcedure
Who is being recruted

Urogenital Diseases+69

+ Genital Diseases

+ Adnexal Diseases

From 18 to 55 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 1998
See protocol details

Summary

Principal SponsorDana-Farber Cancer Institute
Last updated: January 20, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1998

Actual date on which the first participant was enrolled.

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.

NCT00003657
Principal SponsorDana-Farber Cancer Institute
Last updated: January 20, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 55 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesAdnexal DiseasesUrinary Bladder DiseasesBronchial NeoplasmsCarcinomaCarcinoma, BronchogenicCarcinoma, Squamous CellCranial Nerve DiseasesDNA Virus InfectionsEndocrine System DiseasesEndocrine Gland NeoplasmsFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Diseases, MaleGenital Neoplasms, FemaleGenital Neoplasms, MaleGonadal DisordersHerpesviridae InfectionsInfectionsKidney DiseasesLung DiseasesNeoplasm MetastasisNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Connective TissueNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeoplasms, Vascular TissueNeoplastic ProcessesNervous System DiseasesNervous System NeoplasmsNeuroblastomaOvarian DiseasesPathologic ProcessesRespiratory Tract DiseasesRespiratory Tract NeoplasmsPathological Conditions, Signs and SymptomsTesticular DiseasesThoracic NeoplasmsUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsVirus DiseasesNeuroectodermal TumorsNeoplasms, Connective and Soft TissueNeoplasms, Bone TissueNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialOlfactory Nerve DiseasesFemale Urogenital DiseasesMale Urogenital DiseasesSquamous Cell Carcinoma of Head and NeckCarcinoma, Ovarian EpithelialUrinary Bladder NeoplasmsCarcinoma, Non-Small-Cell LungChondrosarcomaHead and Neck NeoplasmsKidney NeoplasmsLung NeoplasmsNeoplasms, Unknown PrimaryOvarian NeoplasmsSarcomaSarcoma, KaposiOsteosarcomaTesticular NeoplasmsCentral Nervous System NeoplasmsNeuroectodermal Tumors, Primitive, PeripheralEsthesioneuroblastoma, OlfactorySmall Cell Lung Carcinoma

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Massachusetts General Hospital Cancer Center

Boston, United StatesOpen Massachusetts General Hospital Cancer Center in Google Maps

Dana-Farber Cancer Institute

Boston, United States

Beth Israel Deaconess Medical Center

Boston, United States
Completed3 Study Centers