NCT00110006

Brief Summary

RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using fludeoxyglucose F 18, may help in learning how well chemotherapy works to kill cancer cells and allow doctors to plan better treatment. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment. PURPOSE: This clinical trial is studying positron emission tomography using fludeoxyglucose F 18 to see how well it works in predicting response to treatment in patients who are receiving rituximab and combination chemotherapy for newly diagnosed non-Hodgkin's lymphoma.

Trial Health

10
At Risk

Trial Health Score

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

Status
withdrawn

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Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2005

Completed
Last Updated

June 11, 2010

Status Verified

June 1, 2010

First QC Date

May 3, 2005

Last Update Submit

June 10, 2010

Conditions

Lymphoma

Keywords

contiguous stage II grade 3 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomastage I grade 3 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 3 follicular lymphomacontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomastage I adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphomacontiguous stage II mantle cell lymphomanoncontiguous stage II mantle cell lymphomastage I mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomaanaplastic large cell lymphoma

Outcome Measures

Primary Outcomes (3)

  • Complete remission as measured by positron emission tomography (PET) at 7-10 days after R-CHOP, and after completion of study treatment

    at 7-10 days after R-CHOP, and after completion of study treatment

  • Overall survival at 7-10 days after R-CHOP, and after completion of study treatment

    at 7-10 days after R-CHOP, and after completion of study treatment

  • Disease-free survival at 7-10 days after R-CHOP, and after completion of study treatment

    at 7-10 days after R-CHOP, and after completion of study treatment

Interventions

rituximabBIOLOGICAL

Rituximab IV over 3-6 hours. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.

cyclophosphamideDRUG

Cyclophosphamide IV over 30 minutes. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.

doxorubicin hydrochlorideDRUG

Doxorubicin IV over 5 minutes. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.

prednisoneDRUG

Oral prednisone once daily on days 1-5. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.

vincristine sulfateDRUG

Vincristine IV over 5 minutes on day 1. Treatment repeats every 14-21 days for up to 4 courses in the absence of unacceptable toxicity.

positron emission tomographyPROCEDURE

Beginning 1 hour after receiving fludeoxyglucose F 18, patients undergo whole-body positron emission tomography (PET) scanning. Patients undergo repeat \^18FDG-PET scanning between days 7-10 of course 1, between courses 3 and 4, and then at the completion of R-CHOP.

fludeoxyglucose F 18RADIATION

Patients receive fludeoxyglucose F 18 (\^18FDG) IV.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed newly diagnosed non-Hodgkin's lymphoma (NHL) * Intermediate- or high-grade disease * Stage I-IV disease * Any of the following subtypes are allowed: * Diffuse large B-cell lymphoma * Anaplastic large cell lymphoma * Mantle cell lymphoma * Grade 3 follicular lymphoma * Mediastinal B-cell lymphoma * The following subtypes are not allowed: * Lymphoblastic lymphoma * Mycosis fungoides/Sézary's syndrome * HTLV-1 associated T-cell leukemia or lymphoma * Primary CNS lymphoma * HIV-associated lymphoma * Transformed lymphoma * Burkitt's lymphoma * Adequate staging of lymphoma by any of the following methods: * CT scan or MRI of affected sites * Unilateral or bilateral bone marrow biopsy * Positive pre-treatment positron emission tomography (PET) scan * Lumbar puncture * Radiographically measurable disease by PET scan * Any International Prognostic Index risk category allowed * No prior diagnosis of another hematologic malignancy 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 * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * Absolute neutrophil count \> 1,000/mm\^3\* * Platelet count ≥ 75,000/mm\^3\* NOTE: \*Unless due to NHL Hepatic * Bilirubin ≤ 2.0 mg/dL\* (excluding Gilbert's disease) NOTE: \*Unless due to NHL Renal * Creatinine ≤ 2.0 mg/dL (unless due to NHL) Cardiovascular * Ejection fraction ≥ 45% by echocardiogram or MUGA Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No other malignancy within the past 5 years except superficial nonmelanoma skin cancer or carcinoma in situ of the cervix * No other serious co-morbid disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No prior rituximab for NHL * No concurrent filgrastim \[G-CSF\] during course 1 of study treatment except for patients \> 70 years of age OR patients with active infection Chemotherapy * No prior chemotherapy for NHL Endocrine therapy * No prior steroids for NHL Radiotherapy * No prior radiotherapy for NHL * Concurrent consolidation radiotherapy to sites of bulky disease allowed at the discretion of the attending physician Surgery * Not specified Other * No other prior treatment for NHL

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

LymphomaLymphoma, FollicularLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-CellLymphoma, Large-Cell, Anaplastic

Interventions

RituximabCyclophosphamideDoxorubicinPrednisoneVincristineMagnetic Resonance SpectroscopyFluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesDeoxyglucoseDeoxy Sugars

Study Officials

  • Panayiotis Savvides, MD

    Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 3, 2005

First Posted

May 4, 2005

Study Start

December 1, 2004

Last Updated

June 11, 2010

Record last verified: 2010-06