NCT00592111

Brief Summary

Study Hypothesis: Clinical staging without laparotomy/splenectomy is adequate for children and young adults with Hodgkin's disease who receive chemotherapy as a component of treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 1996

Longer than P75 for phase_2

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, 1996

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 1999

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

2.9 years

First QC Date

December 26, 2007

Last Update Submit

December 21, 2015

Conditions

PediatricHodgkin's Disease

Keywords

PediatricHodgkin's Disease96-016

Outcome Measures

Primary Outcomes (1)

  • Determine the role of adjuvant low dose involved field radiotherapy in pediatric patients with Hodgkin's disease who attain a complete response following initial chemotherapy

    Conclusion of the study

Study Arms (3)

1

EXPERIMENTAL
Drug: COPP/ABV

2

EXPERIMENTAL
Drug: COPP/ABV

3

EXPERIMENTAL
Drug: intensive chemo with concurrent growth factor

Interventions

COPP/ABVDRUG

4 courses of COPP/ABV hybrid

Also known as: Cyclophosphamide, Vincristine, Procarbazine, Prednisone, Adriamycin, Bleomycin, Vinblastine
1
intensive chemo with concurrent growth factorDRUG

6 cycles (2 courses) of intensive chemotherapy with concurrent growth factor

Also known as: Cyclophosphamide, Vincristine, Procarbazine, Prednisone, Adriamycin, Bleomycin, Vinblastine, Cytosine Arabinoside, Etoposide, G-CSF (Filgrastim)
3

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
* Age less than 21 years at diagnosis * Previously untreated, pathologically confirmed diagnosis of Hodgkin's disease. * Informed patient/parental consent as required by individual institution and in accordance with the Dept of Health and Human Services * Approval of this protocol by the individual institutional Human Subjects Review Committee. * Indicate Hodgkin's disease clinical stage. * Indicate presence or absence of "B" symptoms. * For Stage I and II disease indicate the following: * presence or absence of bulk disease * number of involved nodal regions * presence or absence of hilar adenopathy

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

MeSH Terms

Conditions

Hodgkin Disease

Interventions

CVPPABO protocolCyclophosphamideVincristineProcarbazinePrednisoneDoxorubicinBleomycinVinblastineCytarabineEtoposideGranulocyte Colony-Stimulating FactorFilgrastim

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesBenzamidesAmidesBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsAminoglycosidesGlycosidesCarbohydratesGlycopeptidesGlycoconjugatesPeptidesAmino Acids, Peptides, and ProteinsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesColony-Stimulating FactorsGlycoproteinsHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsProteinsBiological Factors

Study Officials

  • Tanya Trippett, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 11, 2008

Study Start

March 1, 1996

Primary Completion

February 1, 1999

Study Completion

January 1, 2008

Last Updated

December 23, 2015

Record last verified: 2015-12

Locations

US(1)