Status:
WITHDRAWN
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
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00110006
Start Date
December 1 2004
Last Update
June 11 2010
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