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Positron Emission Tomography Using Fludeoxyglucose F 18 in Predicting Response to Treatment in Patients Who Are Receiving Rituximab and Combination Chemotherapy for Newly Diagnosed Non-Hodgkin's Lymphoma
Prognostic Significance of Early Positron Emission Tomography (PET) With Fluorine-18 Fluorodeoxyglucose ([18F] FDG) in Intermediate and High Grade Non-Hodgkin's Lymphoma
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.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
OBJECTIVES:
- Determine the positive and negative predictive values of early positron emission tomography (PET) scanning using fludeoxyglucose F 18 in terms of the probability of patients with newly diagnosed intermediate- or high-grade non-Hodgkin's lymphoma who achieve or do not achieve complete remission, after treatment with 1 course of rituximab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone.
- Determine event free and overall survival of patients with an early positive and negative PET scan treated with this regimen.
- Determine the predictive value of early PET scan response ratio as a continuous variable in terms of response to therapy (assessed at the end of therapy), disease-free survival, and overall survival, in patients treated with this regimen.
- Correlate International Prognostic Index score at presentation with early PET scan results and overall outcome in patients treated with this regimen.
- Correlate the degree of neutropenia 7 to 10 days after the first course of treatment with rituximab and combination chemotherapy with PET scan response and pre-treatment blood CD34-positive cell concentration in these patients.
OUTLINE: This is a multicenter study.
Patients receive fludeoxyglucose F 18 (^18FDG) IV. Beginning 1 hour later, patients undergo whole-body positron emission tomography (PET) scanning. Patients also undergo conventional radiographic staging of their disease.
Patients then receive standard R-CHOP (or an alternative regimen) comprising rituximab IV over 3-6 hours, cyclophosphamide IV over 30 minutes, doxorubicin IV over 5 minutes, and vincristine IV over 5 minutes on day 1 and 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.
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. Patients also undergo radiographic restaging of their disease between courses 3 and 4 and at the completion of R-CHOP.
After completion of study treatment, patients are followed every 3-4 months for 2 years, every 6 months for 1 year, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within 2 years.
Studietype
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Diagnostisch
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
---|---|
Complete remission as measured by positron emission tomography (PET) at 7-10 days after R-CHOP, and after completion of study treatment
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie stoel: Panayiotis Savvides, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Studie record data
Bestudeer belangrijke data
Studie start
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
- stadium III volwassen diffuus grootcellig lymfoom
- stadium IV graad 3 folliculair lymfoom
- stadium IV volwassen diffuus grootcellig lymfoom
- stadium III graad 3 folliculair lymfoom
- stadium III mantelcellymfoom
- stadium IV mantelcellymfoom
- anaplastisch grootcellig lymfoom
- aaneengesloten stadium II mantelcellymfoom
- niet-aaneengesloten stadium II mantelcellymfoom
- niet-aaneengesloten stadium II volwassen diffuus grootcellig lymfoom
- niet-aangrenzend stadium II graad 3 folliculair lymfoom
- stadium I mantelcellymfoom
- aaneengesloten stadium II graad 3 folliculair lymfoom
- stadium I graad 3 folliculair lymfoom
- aaneengesloten stadium II volwassen diffuus grootcellig lymfoom
- stadium I volwassen diffuus grootcellig lymfoom
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het immuunsysteem
- Neoplasmata per histologisch type
- Neoplasmata
- Lymfoproliferatieve aandoeningen
- Lymfatische ziekten
- Immunoproliferatieve aandoeningen
- Lymfoom
- Lymfoom, non-Hodgkin
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Ontstekingsremmende middelen
- Antireumatische middelen
- Antineoplastische middelen
- Immunosuppressieve middelen
- Immunologische factoren
- Tubuline-modulatoren
- Antimitotische middelen
- Mitose modulatoren
- Glucocorticoïden
- Hormonen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Antineoplastische middelen, hormonaal
- Antineoplastische middelen, alkylering
- Alkyleringsmiddelen
- Myeloablatieve agonisten
- Antineoplastische middelen, fytogeen
- Topoisomerase II-remmers
- Topoisomeraseremmers
- Antineoplastische middelen, immunologisch
- Radiofarmaca
- Antibiotica, antineoplastiek
- Cyclofosfamide
- Fluorodeoxyglucose F18
- Rituximab
- Prednison
- Doxorubicine
- Liposomale doxorubicine
- Vincristine
Andere studie-ID-nummers
- CASE2404
- P30CA043703 (Subsidie/contract van de Amerikaanse NIH)
- CASE-CWRU-2404 (Andere identificatie: Case Comprehensive Cancer Center)
- CWRU-100401
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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