NCT00544570

Brief Summary

RATIONALE: Giving high-dose chemotherapy before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or by killing them. Giving colony-stimulating factors, such as G-CSF, helps stem cells move from the bone marrow to the blood so they can be collected and stored. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by high-dose chemotherapy and radiation therapy. PURPOSE: This clinical trial is studying the side effects and how well high-dose chemotherapy works in treating patients undergoing stem cell transplant for recurrent or refractory Hodgkin's lymphoma.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable lymphoma

Timeline
Completed

Started Apr 1998

Longer than P75 for not_applicable lymphoma

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

April 1, 1998

Completed
9.5 years until next milestone

First Submitted

Initial submission to the registry

October 13, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 16, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

February 9, 2010

Status Verified

February 1, 2010

Enrollment Period

9.7 years

First QC Date

October 13, 2007

Last Update Submit

February 5, 2010

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphomarecurrent/refractory childhood Hodgkin lymphoma

Outcome Measures

Primary Outcomes (2)

  • Feasibility

  • Toxicity as assessed by NCI CTC v2.0

Secondary Outcomes (4)

  • Response rate

  • Progression-free survival

  • Overall survival

  • Percentage of patients who achieve minimal disease status after 2 courses

Interventions

filgrastimBIOLOGICAL
carmustineDRUG
cyclophosphamideDRUG
etoposideDRUG
melphalanDRUG
autologous hematopoietic stem cell transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION
total-body irradiationRADIATION

Eligibility Criteria

AgeUp to 64 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • SWOG performance status 0-1
  • LVEF \> 50% by 2D-ECHO or MUGA scan
  • Patients with LVEF between 45-50% and without wall motion abnormalities are assessed on an individual basis after consultation with the cardiologist
  • FEV\_1 or DLCO \> 45% predicted
  • Creatinine clearance \> 60 mL/min
  • HIV-negative
  • Hepatitis B surface antigen-negative
  • Hepatitis C virus-negative
  • ALT ≤ 5 times upper limit of normal
  • No inadequate vital organ function
  • No active infection
  • Fertile patients must use adequate contraception
  • PRIOR CONCURRENT THERAPY:
  • See Disease Characteristics
  • Concurrent, post-transplantation, consolidative radiotherapy to residual masses allowed provided the patient has engrafted with a WBC \> 4,000/μL and a platelet count \> 100,000/μL

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

LymphomaHodgkin DiseaseRecurrence

Interventions

FilgrastimCarmustineCyclophosphamideEtoposideMelphalanPeripheral Blood Stem Cell TransplantationRadiotherapyWhole-Body Irradiation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsNitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Eileen P. Smith, MD

    City of Hope Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 13, 2007

First Posted

October 16, 2007

Study Start

April 1, 1998

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 9, 2010

Record last verified: 2010-02