NCT00003081

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. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase I trial to study the effectiveness of combination chemotherapy, peripheral stem cell transplantation, and radiation therapy in treating patients with recurrent metastatic Ewing's sarcoma, peripheral primitive neuroectodermal tumor, or rhabdomyosarcoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Mar 1998

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 1998

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2002

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

April 27, 2004

Completed
Last Updated

September 20, 2010

Status Verified

September 1, 2010

Enrollment Period

3.8 years

First QC Date

November 1, 1999

Last Update Submit

September 16, 2010

Conditions

Sarcoma

Keywords

recurrent childhood rhabdomyosarcomarecurrent adult soft tissue sarcomaadult rhabdomyosarcomarecurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor

Interventions

filgrastimBIOLOGICAL
busulfanDRUG
melphalanDRUG
thiotepaDRUG
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

AgeUp to 49 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: Histologically confirmed recurrent metastatic Ewing's sarcoma, peripheral primitive neuroectodermal tumor (PNET) or Clinical Group IV rhabdomyosarcoma Complete remission or very good partial remission (at least 50% reduction in measurable tumor burden) following initial chemotherapy with or without surgery No primary CNS PNET PATIENT CHARACTERISTICS: Age: Under 50 Performance status: Karnofsky 70-100% Life expectancy: Greater than 3 months Hematopoietic: Granulocyte count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL Renal: Creatinine clearance greater than 50% of normal Pulmonary: LVEF greater than 41% Other: HIV negative Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: No prior dose limiting irradiation to any organ site Surgery: See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • Hawkins D, Barnett T, Bensinger W, Gooley T, Sanders J. Busulfan, melphalan, and thiotepa with or without total marrow irradiation with hematopoietic stem cell rescue for poor-risk Ewing-Sarcoma-Family tumors. Med Pediatr Oncol. 2000 May;34(5):328-37. doi: 10.1002/(sici)1096-911x(200005)34:53.0.co;2-4.

    PMID: 10797354RESULT

MeSH Terms

Conditions

SarcomaRhabdomyosarcomaNeuroectodermal Tumors, Primitive, Peripheral

Interventions

FilgrastimBusulfanMelphalanThiotepaPeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsMyosarcomaNeoplasms, Muscle TissueNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsButylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsPhosphoramidesOrganophosphorus CompoundsTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Jean E. Sanders, MD

    Fred Hutchinson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 27, 2004

Study Start

March 1, 1998

Primary Completion

January 1, 2002

Study Completion

January 1, 2002

Last Updated

September 20, 2010

Record last verified: 2010-09

Locations

US(1)