NCT00003632

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients with newly diagnosed CNS lymphoma.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 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

September 1, 1998

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.3 years until next milestone

First Posted

Study publicly available on registry

February 16, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

6.8 years

First QC Date

November 1, 1999

Last Update Submit

January 15, 2013

Conditions

Lymphoma

Keywords

primary central nervous system non-Hodgkin lymphoma

Interventions

filgrastimBIOLOGICAL
carmustineDRUG
cytarabineDRUG
etoposideDRUG
melphalanDRUG
methotrexateDRUG
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed newly diagnosed primary central nervous system (CNS) lymphoma Patients who have inconclusive biopsy or who are not candidates for biopsy may be eligible provided they have a typical cranial MRI or CT scan (presence of hypo, iso, or hyperdense parenchymal contrast-enhancing mass lesions) to insure that leptomeningeal nonparenchymal lymphomas are not included Must meet at least one of the following criteria: Positive CSF cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers Biopsy of the vitreous or uvea demonstrating lymphoma Isolated CNS relapse of systemic non-Hodgkin's lymphoma allowed PATIENT CHARACTERISTICS: Age: Not specified Performance status: Not specified Life expectancy: At least 8 weeks Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL SGOT no greater than 2 times upper limit normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: Ejection fraction at least 50% Pulmonary: DLCO at least 50% Other: HIV-1 negative No other active primary malignancy except basal cell skin cancer or carcinoma in situ of the cervix No prior immunodeficiency (e.g., renal transplantation recipient) PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for CNS lymphoma Endocrine therapy: Not specified Radiotherapy: No prior cranial irradiation Surgery: Not specified

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

Lymphoma

Interventions

FilgrastimCarmustineCytarabineEtoposideMelphalanMethotrexatePeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsNitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Lauren E. Abrey, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

February 16, 2004

Study Start

September 1, 1998

Primary Completion

July 1, 2005

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(1)