NCT00002982

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with peripheral stem cell transplantation works in treating older patients with refractory or relapsed intermediate-grade 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 Jan 1997

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1997

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2005

Completed
Last Updated

July 3, 2013

Status Verified

July 1, 2013

Enrollment Period

8.8 years

First QC Date

November 1, 1999

Last Update Submit

July 1, 2013

Conditions

Lymphoma

Keywords

recurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomaanaplastic large cell lymphoma

Outcome Measures

Primary Outcomes (1)

  • Treatment-related toxicity

Secondary Outcomes (1)

  • Efficacy in terms of 2-year disease-free survival

Interventions

filgrastimBIOLOGICAL
carboplatinDRUG
carmustineDRUG
cytarabineDRUG
etoposideDRUG
ifosfamideDRUG
melphalanDRUG
autologous bone marrow transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE
radiation therapyRADIATION

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Primary refractory intermediate grade non-Hodgkin's lymphoma (NHL) OR * Untreated relapsed intermediate grade NHL with no more than 1 extranodal site of disease * Biopsy proven relapse of diffuse large cell, diffuse mixed cell, diffuse small cleaved cell (excluding mantle cell lymphoma), follicular large cell, anaplastic large cell or immunoblastic NHL in recently attained complete response patients PATIENT CHARACTERISTICS: Age: * 60 and over Performance status: * Karnofsky at least 80% Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2.0 mg/dL unless there is a history of Gilbert's disease Renal: * No history of chronic renal insufficiency * Creatinine no greater than 1.5 mg/dL or if greater than 1.5 mg/dL, then creatinine clearance must be at least 60 mL/min Cardiovascular: * No myocardial infarction within the past 6 months * No unstable angina or cardiac arrhythmias other than chronic atrial fibrillation * Normal cardiac function required; MUGA scan or stress ECG ejection fraction at least 50% without significant wall motion abnormalities Pulmonary: * Adequate pulmonary function defined as DLCO at least 50% of predicted value when corrected for patients hemoglobin and alveolar ventilation Other: * No medical illness unrelated to intermediate grade Non-Hodgkin's Lymphoma * No uncontrolled infection * No history of malignancy other than curatively treated cutaneous basal cell carcinoma; carcinoma in situ of the cervix; axillary node negative breast cancer without prior chemotherapy and disease free for more than 2 years; or prostate cancer with surgery alone and disease free for more than 2 years * No lymphoblastic lymphoma, small noncleaved cell lymphoma, CNS lymphoma or CNS relapse of lymphoma * Not HIV, HBV, and HCV positive PRIOR CONCURRENT THERAPY: * Concurrent enrollment in MSKCC protocol 96-17a allowed Biologic therapy: * Not specified Chemotherapy: * No more than 2 prior chemotherapy regimens Endocrine therapy: * Not specified Radiotherapy: * Not specified 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

LymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticLymphoma, Large-Cell, Anaplastic

Interventions

FilgrastimCarboplatinCarmustineCytarabineEtoposideIfosfamideMelphalanPeripheral Blood Stem Cell TransplantationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellLymphoma, T-Cell

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsCoordination ComplexesOrganic ChemicalsNitrosourea CompoundsUreaAmidesNitroso CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Craig Moskowitz, 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

January 27, 2003

Study Start

January 1, 1997

Primary Completion

October 1, 2005

Study Completion

October 1, 2005

Last Updated

July 3, 2013

Record last verified: 2013-07

Locations

US(1)