NCT00004907

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. Bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and radiation therapy and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of chemotherapy and radiation therapy plus bone marrow or peripheral stem cell transplantation in treating patients who have refractory or relapsed T-cell lymphoma, Hodgkin's lymphoma, or non-Hodgkin's lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 1999

Typical duration for phase_1 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2000

Completed
2.9 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2004

Completed
Last Updated

June 12, 2012

Status Verified

June 1, 2012

Enrollment Period

4.8 years

First QC Date

March 7, 2000

Last Update Submit

June 8, 2012

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent mycosis fungoides/Sezary syndromerecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Interventions

busulfanDRUG
cyclophosphamideDRUG
etoposideDRUG
allogeneic bone marrow transplantationPROCEDURE
bone marrow ablation with stem cell supportPROCEDURE
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: * Histologically proven relapsed or refractory cutaneous T-cell lymphoma, Hodgkin's lymphoma, or non-Hodgkin's lymphoma of the following types: * Diffuse small lymphocytic/marginal zone * Grade I follicular small cleaved cell * Grade II follicular mixed cell * Diffuse small cleaved cell * Grade III follicular large cell * Diffuse mixed cell * Diffuse large cell * Immunoblastic large cell * HLA identical related donor available * Phenotypically HLA identical, MLC nonstimulatory donor eligible if no HLA identical related donor is available * Relapse following autologous bone marrow transplantation allowed if an HLA identical related donor is available * Eligible for total body irradiation * No active uncontrolled CNS disease NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age: * Over 15 to physiologic age 60 Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No congestive heart failure * No myocardial infarction within the past 3 months * No significant arrhythmia requiring medication * Resting LVEF normal Pulmonary: * No significant nonneoplastic pulmonary disease (e.g., chronic obstructive pulmonary disease) that would preclude therapy with cytotoxic drugs * DLCO at least 50% of predicted\* OR * FEV1 and/or FVC at least 50% of predicted\* NOTE: \* Unless due to lymphoma, including Hodgkin's lymphoma Other: * Not pregnant * Negative pregnancy test * No active serious medical condition that would preclude aggressive cytotoxic chemotherapy * HIV negative and 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 at Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

LymphomaHodgkin DiseaseLymphoma, T-Cell, CutaneousLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticMycosis FungoidesSezary SyndromeLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

BusulfanCyclophosphamideEtoposidePeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butylene GlycolsGlycolsAlcoholsOrganic ChemicalsMesylatesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsSulfonic AcidsSulfur AcidsSulfur CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus 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 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2000

First Posted

January 27, 2003

Study Start

October 1, 1999

Primary Completion

August 1, 2004

Study Completion

August 1, 2004

Last Updated

June 12, 2012

Record last verified: 2012-06

Locations

US(1)