NCT00003926

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Chemoprotective drugs such as amifostine may protect normal cells from the side effects of high-dose chemotherapy. PURPOSE: Phase I trial to study the effectiveness of amifostine in protecting from the side effects of peripheral stem cell transplantation in treating patients who have high-risk or relapsed solid tumors.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 1998

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1998

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2002

Completed
9 months until next milestone

First Posted

Study publicly available on registry

May 2, 2003

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

November 29, 2017

Status Verified

November 1, 2017

Enrollment Period

3.8 years

First QC Date

November 1, 1999

Last Update Submit

November 27, 2017

Conditions

Brain and Central Nervous System TumorsChildhood Germ Cell TumorChordomaKidney CancerLiver CancerNeuroblastomaOvarian CancerRetinoblastomaSarcoma

Keywords

soft tissue sarcomaregional neuroblastomadisseminated neuroblastomarecurrent Wilms tumorrecurrent retinoblastomarecurrent adult brain tumoradult rhabdomyosarcomaovarian germ cell tumorchordomaovarian sarcomaunresectable neuroblastomadesmoplastic small round cell tumorrhabdomyosarcomaEwing sarcomaneuroectodermal tumorteratomamalignant testicular germ cell tumormalignant ovarian germ cell tumorextragonadal germ cell tumormalignant germ cell tumorhepatoblastomaliver cancermedulloblastomacerebellar astrocytomabrain stem gliomagliomacerebral astrocytomaependymoma

Study Arms (2)

Solid/brain tumor patients (1-18 years)

EXPERIMENTAL

Patients with solid tumor or brain tumor in the 1-18 years old stratum.

Drug: amifostine trihydrateDrug: busulfanDrug: filgrastimDrug: melphalanDrug: thiotepaProcedure: peripheral blood stem cell transplantation (PBSC)

Solid/brain tumor patients (19-45 years)

EXPERIMENTAL

Patients with solid tumor or brain tumor in the 19-45 years old stratum.

Drug: amifostine trihydrateDrug: busulfanDrug: filgrastimDrug: melphalanDrug: thiotepaProcedure: peripheral blood stem cell transplantation (PBSC)

Interventions

amifostine trihydrateDRUG

Patients receive amifostine intravenous (IV) over 5 minutes beginning 30 minutes prior to melphalan and thiotepa administration on days -5 to -1. Cohorts of 3-6 patients receive escalating doses of amifostine until the maximum tolerated dose is determined.

Also known as: Ethyol
Solid/brain tumor patients (1-18 years)Solid/brain tumor patients (19-45 years)
busulfanDRUG

Patients receive oral busulfan every 6 hours on days -8 to -6.

Also known as: Busulfex
Solid/brain tumor patients (1-18 years)Solid/brain tumor patients (19-45 years)
filgrastimDRUG

All patients receive filgrastim (G-CSF) IV for 1 week.

Also known as: granulocyte colony-stimulating factor, G-CSF
Solid/brain tumor patients (1-18 years)Solid/brain tumor patients (19-45 years)
melphalanDRUG

melphalan intravenous (IV) over 30 minutes on days -5 and -4

Also known as: Alkeran
Solid/brain tumor patients (1-18 years)Solid/brain tumor patients (19-45 years)
thiotepaDRUG

thiotepa intravenous (IV) over 2 hours on days -3 and -2.

Also known as: Thioplex
Solid/brain tumor patients (1-18 years)Solid/brain tumor patients (19-45 years)
peripheral blood stem cell transplantation (PBSC)PROCEDURE

PBSC are reinfused on day 0

Also known as: bone marrow transplant
Solid/brain tumor patients (1-18 years)Solid/brain tumor patients (19-45 years)

Eligibility Criteria

Age1 Year - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Histologically confirmed high-risk or relapsed solid tumors or brain tumors, including:
  • Metastatic or relapsed Ewing's sarcoma
  • Metastatic or relapsed rhabdomyosarcoma
  • Refractory Wilms' tumor
  • Diffuse anaplastic Wilms' tumor
  • Stage III or IV neuroblastoma
  • Recurrent retinoblastoma
  • Metastatic or relapsed germ cell tumors
  • Metastatic or relapsed other soft tissue sarcomas
  • Small cell ovarian sarcoma
  • Metastatic or relapsed primitive neuroectodermal tumors of the bone
  • Recurrent brain tumors
  • Desmoplastic small round cell tumors
  • Recurrent or metastatic chordomas
  • Metastatic or relapsed hepatoblastoma
  • +16 more criteria

You may not qualify if:

  • Osteogenic sarcoma
  • Less than 4 months
  • Uncontrolled bleeding
  • Congestive heart failure
  • Uncontrolled hypertension
  • Asthma
  • Pregnant or nursing
  • Uncontrolled metabolic disease
  • Active severe infection
  • Allergy to aminothiol compounds
  • Prior bone marrow transplantation
  • Other concurrent investigational agents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsChordomaKidney NeoplasmsLiver NeoplasmsNeuroblastomaOvarian NeoplasmsRetinoblastomaSarcomaWilms TumorBrain NeoplasmsRhabdomyosarcomaDesmoplastic Small Round Cell TumorSarcoma, EwingNeuroectodermal TumorsTeratomaTesticular NeoplasmsOvarian Germ Cell CancerHepatoblastomaMedulloblastomaGliomaAstrocytomaEpendymoma

Interventions

AmifostineBusulfanFilgrastimGranulocyte Colony-Stimulating FactorMelphalanThiotepaPeripheral Blood Stem Cell TransplantationBone Marrow Transplantation

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesDigestive System NeoplasmsDigestive System DiseasesLiver DiseasesNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleGenital DiseasesEndocrine System DiseasesGonadal DisordersRetinal NeoplasmsEye NeoplasmsEye Diseases, HereditaryEye DiseasesRetinal DiseasesNeoplasms, Connective and Soft TissueNeoplasms, Complex and MixedNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBrain DiseasesCentral Nervous System DiseasesMyosarcomaNeoplasms, Muscle TissueOsteosarcomaNeoplasms, Bone TissueNeoplasms, Connective TissueGenital Neoplasms, MaleGenital Diseases, MaleTesticular Diseases

Intervention Hierarchy (Ancestors)

OrganothiophosphatesOrganophosphatesOrganophosphorus CompoundsOrganic ChemicalsOrganothiophosphorus CompoundsSulfur CompoundsButylene GlycolsGlycolsAlcoholsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsPhosphoramidesTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, OperativeTissue Transplantation

Study Officials

  • John P. Perentesis, MD

    Masonic Cancer Center, University of Minnesota

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 2, 2003

Study Start

November 1, 1998

Primary Completion

August 1, 2002

Study Completion

August 1, 2003

Last Updated

November 29, 2017

Record last verified: 2017-11

Locations

US(1)