Gemcitabine Hydrochloride, Carboplatin, Dexamethasone, and Rituximab in Treating Patients With Previously Treated Lymphoid Malignancies
Adult Nasal Type Extranodal NK/T-cell Lymphoma, Anaplastic Large Cell Lymphoma, Angioimmunoblastic T-cell Lymphoma
About this trial
This is an interventional treatment trial for Adult Nasal Type Extranodal NK/T-cell Lymphoma
Eligibility Criteria
Inclusion Criteria: Patients must have relapsed or primary refractory lymphoid malignancy (including B-cell, T-cell, or Hodgkin's Disease) Revised European American classification (REAL), or World Health Organization (WHO) classification of patients malignancies must be provided Patients must have measurable disease defined as lesions that can be accurately measured in two dimensions by computed tomography (CT), magnetic resonance imaging (MRI), medical photograph (skin or oral lesion), plain x-ray, or other conventional technique and a greatest transverse diameter of 1 cm or greater; or palpable lesions with both diameters >= 2 cm; Note: CT scans remain the standard for evaluation of nodal disease Patients must have a bone marrow aspirate and biopsy within 28 days of enrollment and no intervening anticancer therapy Patients must have a CT of chest, abdomen, and pelvis within 28 days of enrollment; patients with evidence of adenopathy in the neck must have a CT of neck Patients should not have evidence active central nervous system lymphoma Patients must have a Southwest Oncology Group (SWOG) performance status of 0, 1, or 2 Patients should have absolute neutrophil count (ANC) >= 1,500/uL; exception: patients with cytopenia thought to be due to disease in their bone marrow, that do not meet this criteria, may be enrolled on the protocol at the Study Chair's discretion Patients should have platelets >= 100,000/uL; exception: patients with cytopenia thought to be due to disease in their bone marrow, that do not meet this criteria, may be enrolled on the protocol at the Study Chair's discretion Serum bilirubin less than 2 times the upper limit of normal Serum creatinine less than 1.5 times the upper limit of normal and creatinine clearance greater than 50/ mL per minute Patients must have serum lactate dehydrogenase (LDH) performed within 14 days prior to treatment All patients must be informed of the investigational nature of this study and have given written consent in accordance with institutional and federal guidelines Must anticipate that patient will complete at least 2 cycles of chemotherapy Exclusion Criteria: Patients known to be human immunodeficiency virus (HIV) positive Pregnant or nursing women; men or women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method Patients with other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, cervical cancer in situ, or other cancer from which the patient has been disease-free for 5 years or greater unless approved by the Principal Investigator (PI) Patients that are refractory (i.e., not responded or progressed within 6 months) to a carboplatin or cisplatin-based regimen or a gemcitabine-based regimen Patients with active hepatitis B virus (HBV) infection or hepatitis Patients that have other medical conditions that would contraindicate treatment with aggressive chemotherapy
Sites / Locations
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Arms of the Study
Arm 1
Experimental
Treatment
Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on days 1 and 8, carboplatin IV over 30-60 minutes on day 1, and dexamethasone orally (PO) on days 1-4. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients with CD20-POSITIVE LYMPHOMAS also receive rituximab IV on day 8.