NCT00003173

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. PURPOSE: Phase II trial to study the effectiveness of high-dose thiotepa plus peripheral stem cell transplantation in treating patients with refractory solid tumors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 1997

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

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

September 1, 1997

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.5 years until next milestone

First Posted

Study publicly available on registry

April 23, 2003

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
Last Updated

March 7, 2013

Status Verified

March 1, 2013

Enrollment Period

5.7 years

First QC Date

November 1, 1999

Last Update Submit

March 6, 2013

Conditions

Brain and Central Nervous System TumorsChildhood Germ Cell TumorExtragonadal Germ Cell TumorOvarian CancerRetinoblastomaTesticular Germ Cell TumorUnspecified Adult Solid Tumor, Protocol SpecificUnspecified Childhood Solid Tumor, Protocol Specific

Keywords

intraocular retinoblastomarecurrent retinoblastomachildhood central nervous system germ cell tumorstage III malignant testicular germ cell tumorrecurrent malignant testicular germ cell tumorunspecified childhood solid tumor, protocol specificunspecified adult solid tumor, protocol specificchildhood germ cell tumorstage III ovarian germ cell tumorstage IV ovarian germ cell tumorrecurrent ovarian germ cell tumorextragonadal germ cell tumoradult central nervous system germ cell tumorchildhood teratomachildhood malignant testicular germ cell tumorchildhood malignant ovarian germ cell tumorchildhood extragonadal germ cell tumorrecurrent childhood malignant germ cell tumor

Interventions

filgrastimBIOLOGICAL
thiotepaDRUG
autologous bone marrow transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Malignant solid tumors * Must have failed conventional treatment or for whom conventional therapy is not available * Measurable disease by MRI or CT scan * Intraocular retinoblastomas may be measured by direct visualization * Germ cell tumors may be measured by tumor markers * No known bone marrow involvement PATIENT CHARACTERISTICS: Age: * Any age Performance status: * Lansky 60-100% for patients 16 and under * Karnofsky 60-100% for patients over 16 Life expectancy: * At least 8 weeks Hematopoietic: * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 75,000/mm\^3 * If parameters not met, must have adequate stem cell yield Hepatic: * Bilirubin no greater than 1.5 times the upper limit of normal (ULN) * SGOT and SGPT no greater than 2.5 times the ULN (unless liver involvement by tumor) Renal: * Creatinine within normal limits OR * Creatinine clearance at least 70 mL/min Cardiovascular: * Fractional shortening greater than 28% on echocardiogram OR * Ejection fraction at least 55% on RNCA prior to first cycle of thiotepa Pulmonary: * DLCO greater than 55% of predicted (only required if there is clinical evidence of pulmonary dysfunction) Other: * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior bone marrow or peripheral blood stem cell rescue allowed Chemotherapy: * At least 4 weeks since prior chemotherapy if absolute neutrophil count is less than 1,000/mm\^3 or platelet count is less than 75,000/mm\^3, and recovered (i.e. adequate stem cells collected to predict hematopoietic recovery) * No concurrent chemotherapy except for dexamethasone for antiedema effects Endocrine therapy: * No concurrent use of corticosteroids used solely as antiemetics Radiotherapy: * At least 4 weeks since radiotherapy if absolute neutrophil count is less than 1,000/mm\^3 or platelet count is less than 75,000/mm\^3, and recovered (i.e. adequate stem cells collected to predict hematopoietic recovery) * No concurrent radiotherapy Surgery: * Not specified

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

Sponsors & Collaborators

Study Sites (2)

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsOvarian NeoplasmsRetinoblastomaTesticular Germ Cell TumorTesticular NeoplasmsTeratomaOvarian Germ Cell Cancer

Interventions

FilgrastimThiotepaPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueRetinal NeoplasmsEye NeoplasmsEye Diseases, HereditaryEye DiseasesRetinal DiseasesGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPhosphoramidesOrganophosphorus CompoundsOrganic ChemicalsTriethylenephosphoramideAziridinesAzirinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Ira Dunkel, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 23, 2003

Study Start

September 1, 1997

Primary Completion

May 1, 2003

Study Completion

May 1, 2003

Last Updated

March 7, 2013

Record last verified: 2013-03

Locations

US(2)