| S0816 | A Phase II Trial of Response Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging (1722)-
Eligibility: click to view information
DISEASE CHARACTERISTICS:
Histologically confirmed classical Hodgkin lymphoma (i.e., nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted)
Previously untreated stage III or IV disease
No nodular lymphocyte predominant disease
Bidimensionally measurable disease
Adequate biopsy samples from original diagnostic specimen must be available for pathologic review
Tissue obtained from core biopsies allowed
No tissue obtained from needle aspirations or cytologies
Must have known HIV status
No multi-drug resistant HIV infection, CD4 counts < 350/mcL, or other concurrent AIDS-defining conditions in HIV-positive patients
HIV-positive patients with CD4 counts = 350/mcL allowed
Must have undergone unilateral or bilateral bone marrow biopsy within the past 42 days
PATIENT CHARACTERISTICS:
Zubrod performance status 0-2
Serum erythrocyte sedimentation rate, LDH, hemoglobin, albumin, WBC, and lymphocytes measured within the past 28 days
Not pregnant or nursing
Fertile patients must use effective contraception during and for = 6 months after completion of study therapy
No significant cardiac abnormalities as assessed by MUGA scan or ECHO AND cardiac ejection fraction = 45% in patients with a history of hypertension or cardiac symptoms
Hepatitis B-negative (i.e., hepatitis B surface antigen-negative or anti-hepatitis B core antigen-negative)
Patients immune to or immunized against hepatitis B (i.e., anti-hepatitis B surface antibody-positive) are eligible
Hepatitis C-negative (i.e., anti-hepatitis C antibody-negative)
No significant lung disease with abnormal lung function tests (i.e., DLCO > 25% below predicted after correction for hemoglobin) unless attributable to lymphoma
No requirement for continuous supplemental oxygen therapy
No other prior malignancy except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years
PRIOR CONCURRENT THERAPY:
See Disease Characteristics
No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
No prior solid organ transplantation
- Consent Forms: S0816 Consent
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