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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 de junio de 2010 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Fase

  • No aplica

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Complete remission as measured by positron emission tomography (PET) at 7-10 days after R-CHOP, and after completion of study treatment
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Silla de estudio: Panayiotis Savvides, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de diciembre de 2004

Fechas de registro del estudio

Enviado por primera vez

3 de mayo de 2005

Primero enviado que cumplió con los criterios de control de calidad

3 de mayo de 2005

Publicado por primera vez (Estimar)

4 de mayo de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

11 de junio de 2010

Última actualización enviada que cumplió con los criterios de control de calidad

10 de junio de 2010

Última verificación

1 de junio de 2010

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • CASE2404
  • P30CA043703 (Subvención/contrato del NIH de EE. UU.)
  • CASE-CWRU-2404 (Otro identificador: Case Comprehensive Cancer Center)
  • CWRU-100401

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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