NCT00003541

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, radiation therapy, and peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of combination chemotherapy, radiation therapy, and peripheral stem cell transplantation in treating patients who have stage III or stage IV mantle cell lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 lymphoma

Timeline
Completed

Started Jun 1998

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1998

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.2 years until next milestone

First Posted

Study publicly available on registry

January 23, 2004

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

June 24, 2013

Status Verified

June 1, 2013

Enrollment Period

8.1 years

First QC Date

November 1, 1999

Last Update Submit

June 20, 2013

Conditions

Lymphoma

Keywords

stage III mantle cell lymphomastage IV mantle cell lymphoma

Interventions

filgrastimBIOLOGICAL
CHOP regimenDRUG
carboplatinDRUG
cyclophosphamideDRUG
doxorubicin hydrochlorideDRUG
etoposideDRUG
ifosfamideDRUG
prednisoneDRUG
vincristine sulfateDRUG
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV mantle cell lymphoma (diffuse, nodular, mantle zone, or blastic variants) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No chronic active or persistent hepatitis Bilirubin less than 2 mg/dL (unless history of Gilbert's disease) Renal: No history of chronic renal insufficiency Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: At least 6 months since myocardial infarction No unstable angina No cardiac arrhythmias other than chronic atrial fibrillation LVEF at least 50% Pulmonary: DLCO at least 50% Other: No medical illness that would preclude study treatment No uncontrolled infection No history of malignancy, other than curatively treated basal cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Fertile patients must use effective contraception Not HIV positive PRIOR CONCURRENT THERAPY: No prior therapy

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, 10021, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, Mantle-Cell

Interventions

FilgrastimVAP-cyclo protocolCarboplatinCyclophosphamideDoxorubicinEtoposideIfosfamidePrednisoneVincristinePeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCoordination ComplexesOrganic ChemicalsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosidesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Carol S. Portlock, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 23, 2004

Study Start

June 1, 1998

Primary Completion

July 1, 2006

Study Completion

July 1, 2006

Last Updated

June 24, 2013

Record last verified: 2013-06

Locations

US(1)