NCT00004169

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy, radiation therapy, and peripheral stem cell transplantation in treating patients who have recurrent or refractory Hodgkin's disease.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Nov 1993

Longer than P75 for phase_2 lymphoma

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1993

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

December 10, 1999

Completed
4.6 years until next milestone

First Posted

Study publicly available on registry

July 26, 2004

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

July 2, 2012

Status Verified

June 1, 2012

Enrollment Period

13.2 years

First QC Date

December 10, 1999

Last Update Submit

June 21, 2012

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphomarecurrent/refractory childhood Hodgkin lymphoma

Interventions

carboplatinDRUG
cyclophosphamideDRUG
etoposideDRUG
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

AgeUp to 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically proven Hodgkin's disease Refractory to standard therapy OR Relapsed following initial complete remission Measurable or evaluable disease Hepatic involvement must be histologically proven to be considered sole area of measurable disease If referred following successful induction therapy, measurable or evaluable disease not required No CNS disease PATIENT CHARACTERISTICS: Age: Physiologic 65 or under Performance status: ECOG 0-2 Life expectancy: At least 2 months Hematopoietic: Not specified Hepatic: Not specified Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 50 mL/min Cardiovascular: No active heart disease No congestive heart failure No myocardial infarction in the past 3 months No significant arrhythmia requiring medication Ejection fraction normal Pulmonary: No significant nonneoplastic pulmonary disease No chronic obstructive pulmonary disease Diffusing capacity at least 50% predicted OR FEV1 and/or FVC at least 75% predicted (unless due to Hodgkin's disease) Other: Not pregnant Negative pregnancy test No active serious medical condition that would preclude chemotherapy HIV negative No clinical evidence of AIDS PRIOR CONCURRENT THERAPY: 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)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

LymphomaHodgkin DiseaseRecurrence

Interventions

CarboplatinCyclophosphamideEtoposidePeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Leo I. Gordon, MD

    Robert H. Lurie Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 1999

First Posted

July 26, 2004

Study Start

November 1, 1993

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

July 2, 2012

Record last verified: 2012-06

Locations

US(1)