A Phase 2 Open Label, Randomized, Dose And Schedule Finding, Clinical Trial Of Immunotherapy With AMG 412 In Subjects With Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma (NHL)
- Relapsed or refractory after at least 1 regimen of standard therapy
- Prior therapy may include high-dose chemotherapy with autologous stem cell
transplantation (ASCT) or immunotherapy
- Bidimensionally measurable disease
- At least 1 lesion at least 1.5 cm by CT scan
- No primary or secondary CNS lymphoma
- No HIV-related lymphoma
- No known or suspected transformed lymphoma (prior or concurrent)
- No bulky disease (i.e., any single mass greater than 10.0 cm)
- No pleural effusion with positive cytology for lymphoma
- Most recent pathology specimen available for collection
- No rapid disease progression or symptoms that indicate disease progression requiring
rapid intervention within the past 2 weeks (e.g., severe shortness of breath, severe
pain, or gastrointestinal or genitourinary obstruction)
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 4 months
Hematopoietic
- Absolute neutrophil count at least 1,000/mm3
- Platelet count at least 50,000/mm3 (transfusion independent)
- Hemoglobin at least 9.0 g/dL
Hepatic
- Bilirubin no greater than 2 times upper limit of normal (ULN)
- AST and ALT less than 5 times ULN
- Hepatitis B surface antigen negative
- Hepatitis C negative
Renal
- Creatinine no greater than 2 times ULN
Other
- HIV negative
- No other primary malignancy within the past 3 years except squamous cell or basal
cell skin cancer, carcinoma in situ of the cervix, or stage I prostate cancer
- No other serious nonmalignant condition that would preclude study
- No serious infection
- No known human antichimeric antibodies or human antihuman antibody positivity
- No type 1 hypersensitivity or anaphylactic reactions to murine proteins
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for at least 6 months
after study
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- At least 4 weeks since prior immunotherapy (unless clearly progressing)
- At least 12 weeks since prior ASCT
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy (unless clearly progressing)
Endocrine therapy
- Not specified
Radiotherapy
- No prior radioimmunotherapy
Surgery
- At least 4 weeks since prior major surgery (unless patient has fully recovered)
Other
- At least 30 days since prior enrollment in clinical trials involving investigational
devices or drugs
- No concurrent enrollment in other clinical trials involving investigational devices
or drugs
- No concurrent investigational agents for disease other than NHL