- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00110006
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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Complete remission as measured by positron emission tomography (PET) at 7-10 days after R-CHOP, and after completion of study treatment
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Panayiotis Savvides, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
- Lymphome diffus à grandes cellules de stade III chez l'adulte
- Lymphome folliculaire de stade IV de grade 3
- Lymphome diffus à grandes cellules de stade IV chez l'adulte
- Lymphome folliculaire stade III grade 3
- lymphome à cellules du manteau de stade III
- lymphome à cellules du manteau de stade IV
- lymphome anaplasique à grandes cellules
- lymphome contigu à cellules du manteau de stade II
- lymphome à cellules du manteau de stade II non contigu
- Lymphome diffus à grandes cellules non contigu de stade II de l'adulte
- lymphome folliculaire non contigu de stade II grade 3
- lymphome à cellules du manteau de stade I
- lymphome folliculaire contigu de stade II grade 3
- Lymphome folliculaire de stade I de grade 3
- Lymphome diffus à grandes cellules contigu de stade II chez l'adulte
- Lymphome diffus à grandes cellules de stade I de l'adulte
Termes MeSH pertinents supplémentaires
- Maladies du système immunitaire
- Tumeurs par type histologique
- Tumeurs
- Troubles lymphoprolifératifs
- Maladies lymphatiques
- Troubles immunoprolifératifs
- Lymphome
- Lymphome non hodgkinien
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents anti-inflammatoires
- Agents antirhumatismaux
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Glucocorticoïdes
- Les hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Agents antinéoplasiques, hormonaux
- Agents antinéoplasiques, alkylants
- Agents d'alkylation
- Agonistes myéloablatifs
- Agents antinéoplasiques phytogéniques
- Inhibiteurs de la topoisomérase II
- Inhibiteurs de la topoisomérase
- Agents antinéoplasiques immunologiques
- Radiopharmaceutiques
- Antibiotiques, Antinéoplasiques
- Cyclophosphamide
- Fluorodésoxyglucose F18
- Rituximab
- Prednisone
- Doxorubicine
- Doxorubicine liposomale
- Vincristine
Autres numéros d'identification d'étude
- CASE2404
- P30CA043703 (Subvention/contrat des NIH des États-Unis)
- CASE-CWRU-2404 (Autre identifiant: Case Comprehensive Cancer Center)
- CWRU-100401
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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