Status:
COMPLETED
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
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Lymphoma
Eligibility:
All Genders
18-120 years
Phase:
PHASE2
Brief 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 c...
Detailed Description
OBJECTIVES: Primary * Determine event-free survival of patients with aggressive non-Hodgkin's lymphoma treated with early high-dose therapy and autologous peripheral blood stem cell (PBSC) or bone m...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 17 2007
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00238368
Start Date
February 1 2004
End Date
September 17 2007
Last Update
November 6 2017
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410