Fludeoxyglucose F 18 Positron Emission Tomography in Predicting Risk of Relapse in Patients With Non-Hodgkin's Lymphoma Who Are Undergoing Combination Chemotherapy With or Without Autologous Stem Cell or Bone Marrow Transplant

• Status: Completed
• Trial end date: 2007-09-17
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Giving chemotherapy with an autologous stem cell or bone marrow transplant may allow more chemotherapy to be given so that more cancer cells are killed. Procedures, such as fludeoxyglucose F 18 positron emission tomography (FDG-PET) (done during chemotherapy) may help doctors predict a patient's risk of relapse and help plan the best treatment.

PURPOSE: This phase II trial is studying how well FDG-PET works in predicting risk of relapse in patients with aggressive non-Hodgkin's lymphoma who are undergoing combination chemotherapy with or without autologous stem cell or bone marrow transplant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Busulfan; Cyclophosphamide; Cytarabine; Doxorubicin; Etoposide; Fluorodeoxyglucose F18; Liposomal doxorubicin; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Prednisone; Rituximab; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed aggressive non-Hodgkin's lymphoma of 1 of the following subtypes:

• Diffuse large B-cell lymphoma

• Mediastinal (thymic) B-cell lymphoma

• Grade 3 follicular lymphoma

• Anaplastic large cell lymphoma

• Peripheral T-cell lymphoma

• Must have adequate staging of disease by the following techniques:

• CT scan or MRI of affected sites

• Bone marrow biopsy (in cases where results influence the duration of chemotherapy only)

• Lumbar puncture (if clinically indicated)

• Stage I-IV disease

• Any International Prognostic Index risk category

• Radiographically measurable disease

• None of the following aggressive non-Hodgkin's subtypes are allowed:

• Mantle cell lymphoma

• Lymphoblastic lymphoma

• Burkitt's lymphoma

• Mycosis fungoides/Sezary's syndrome

• HTLV-1-associated T-cell leukemia/lymphoma

• Primary CNS lymphoma

• HIV-associated lymphoma

• Transformed lymphomas

• No prior diagnosis of another hematologic malignancy

• No known progressive disease during prior first-line chemotherapy

• No active CNS involvement by lymphoma, except CNS involvement at diagnosis that is previously treated and in remission

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-4 (0-2 for peripheral blood stem cell [PBSC] or bone marrow transplantation [BMT] patients)

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count > 1,000/mm^3*

• Platelet count ≥ 75,000/mm^3 NOTE: *PBSC or BMT patients only

Hepatic

• Bilirubin ≤ 2.0 mg/dL unless due to Gilbert's disease or lymphoma*

• No known significant hepatic dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: *PBSC or BMT patients only

Renal

• Creatinine ≤ 2.0 mg/dL*

• No known significant renal dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: *PBSC or BMT patients only

Cardiovascular

• Ejection fraction ≥ 45% by echocardiogram or MUGA*

• No known significant cardiac dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: *PBSC or BMT patients only; a cardiology consult and evaluation may override ejection fraction criterion

Pulmonary

• FEV_1 and FVC ≥ 50% of predicted for patients who have not received thoracic or mantle radiotherapy (75% of predicted for patients who have received thoracic or mantle radiotherapy)*

• No known significant pulmonary dysfunction that is not expected to improve and would preclude PBSC or BMT NOTE: *PBSC or BMT patients only

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 3 years except carcinoma in situ of the cervix or nonmelanoma skin cancer

• No known HIV positivity OR HIV negative (for PBSC or BMT patients only)

• No serious illness that would preclude study participation

• No contraindication to autologous BMT

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics

• No more than 3 prior courses of chemotherapy for lymphoma

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified