Oblimersen and Gemcitabine in Treating Patients With Advanced Solid Tumor or Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue, Nodal Marginal Zone B-cell Lymphoma, Recurrent Adult Burkitt Lymphoma
About this trial
This is an interventional treatment trial for Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Eligibility Criteria
Inclusion Criteria: Histologically confirmed malignancy for which there is no standard or effective curative or palliative therapy Solid tumors and lymphoma allowed Metastatic or unresectable disease Measurable or evaluable nonmeasurable disease Evaluable nonmeasurable disease includes ascites, pleural/pericardial effusions, lymphangitis cutis/pulmonis, inflammatory breast disease, abdominal masses not followed by CT scan or MRI, or cystic lesions Disease characterized by elevated serum tumor marker alone is allowed No known brain metastases Performance status - ECOG 0-2 Performance status - Karnofsky 60-100% More than 3 months Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 mg/dL AST and ALT no greater than 2.5 times upper limit of normal No history of portal hypertension No history of cirrhosis or hepatitis No radiographic evidence of cirrhosis and/or varices Creatinine normal Creatinine clearance at least 60 mL/min No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior allergic reaction attributed to compounds of similar chemical or biological composition to oblimersen or other study agents No other concurrent uncontrolled illness that would preclude study participation No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No concurrent prophylactic colony-stimulating factors such as filgrastim (G-CSF) or sargramostim (GM-CSF) Concurrent interventional growth factors allowed No growth factor administration within 24 hours before study chemotherapy Concurrent epoetin alfa allowed No more than 3 prior chemotherapy regimens More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) More than 2 weeks since prior hormonal therapy Concurrent megestrol for anorexia/cachexia allowed No prior pelvic or whole abdominal radiotherapy More than 4 weeks since prior radiotherapy More than 4 weeks since prior major surgery Recovered from prior therapy More than 4 weeks since prior investigational therapy No prior oblimersen No other concurrent investigational agents No other concurrent anticancer therapy No concurrent combination antiretroviral therapy for HIV-positive patients
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Experimental
Treatment (oblimersen sodium and gemcitabine hydrochloride)
Patients receive oblimersen IV continuously on days 1-5 and gemcitabine IV over 2-3 hours on day 5. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.