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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

10 juin 2010 mis à jour par: Case Comprehensive Cancer Center

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

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

Interventionnel

Phase

  • N'est pas applicable

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

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

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

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

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 décembre 2004

Dates d'inscription aux études

Première soumission

3 mai 2005

Première soumission répondant aux critères de contrôle qualité

3 mai 2005

Première publication (Estimation)

4 mai 2005

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

11 juin 2010

Dernière mise à jour soumise répondant aux critères de contrôle qualité

10 juin 2010

Dernière vérification

1 juin 2010

Plus d'information

Termes liés à cette étude

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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