Overview

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

Status:
Withdrawn
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborator:
National Cancer Institute (NCI)
Treatments:
Cyclophosphamide
Doxorubicin
Fluorodeoxyglucose F18
Liposomal doxorubicin
Prednisone
Rituximab
Vincristine
Criteria
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