Phase I Safety Study Of 131I-Lym-1 For The Treatment Of Previously Treated Diffuse Large B-Cell Lymphoma
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed B-cell diffuse large cell lymphoma
- L-26 positive (i.e., CD20-positive)
- Failed 2 prior chemotherapy regimens
- At least 1 measurable lesion
- At least 2 cm by physical exam or CT scan
- No active lymphomatous meningitis or other CNS involvement by lymphoma
- No significant marrow involvement (i.e., more than 20% of hematopoietic marrow
elements from iliac crest biopsy)
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Karnofsky 60-100%
Life expectancy:
- At least 3 months
Hematopoietic:
- WBC at least 3,500/mm3
- Granulocyte count at least 1,500/mm3
- Platelet count at least 125,000/mm3
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- AST/ALT no greater than 3 times ULN
- Alkaline phosphatase no greater than 3 times ULN
Renal:
- Creatinine no greater than 2 times ULN
Cardiovascular:
- No electrocardial evidence of Q-wave myocardial infarction within the past 6 months
- No congestive heart failure
- No New York Heart Association class III or IV heart disease
Other:
- HIV negative
- Negative human anti-mouse antibodies (i.e., less than 74 ng/mL)
- No known antiplatelet antibodies
- No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior bone marrow or peripheral blood stem cell transplantation
- No prior radioimmunotherapy
- Prior unlabeled monoclonal antibody therapy allowed
- At least 120 hours since prior filgrastim (G-CSF) or sargramostim (GM-CSF)
- At least 1 month since prior epoetin alfa
Chemotherapy:
- See Disease Characteristics
- No concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Biologic therapy
- No prior total body irradiation (TBI)
- At least 6 months since prior radiotherapy (over 3,00 cGy) to more than 20% of
marrow-bearing space (i.e., pelvis and spine)
- No concurrent large-field radiotherapy (i.e., TBI, hemibody radiation, or radiation
fields that include more than 20% of active marrow to a dose of over 3,000 cGy)
- Concurrent localized radiotherapy is allowed to current or impending serious
complication (e.g., bronchial obstruction by hilar lymph nodes or impending fracture
due to lytic bone lesions)
Surgery:
- Not specified
Other:
- Recovered from prior anti-lymphoma therapy
- At least 120 hours since prior whole blood or platelet transfusion
- No concurrent anticoagulants or antiplatelet drugs
- No concurrent medications known to inhibit blood clotting or platelet aggregation
(e.g., aspirin)