This pilot phase II trial studies the side effects and how well giving gemcitabine hydrochloride, carboplatin, dexamethasone, and rituximab together works in treating patients with previously treated lymphoid malignancies. Drugs used in chemotherapy, such as gemcitabine hydrochloride, carboplatin, and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving more than one drug (combination chemotherapy) and giving monoclonal antibody therapy with chemotherapy may kill more cancer cells
OBJECTIVES: I. To determine the feasibility and safety of Gemcitabine/Carboplatin/Dexamethasone with or without Rituximab in previously treated lymphoid malignancies (rituximab will only be evaluated in CD20 positive malignancies). II. To determine the efficacy of the above regimen. III. To determine the ability to proceed to blood stem peripheral blood collection following the above regimens (the impact of above regimen on stem cell reserve). IV. To determine remission duration. All patients are treated with gemcitbine, carboplatin, and dexamethasone. Patients with CD20 + lymphomas also receive rituximab. After completion of study treatment, patients are followed up at 3-4 weeks and then every 6 months for 5 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Given IV
Given IV
Given PO
Given IV in CD20-POSITIVE LYMPHOMAS cases
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Ability to Successfully Deliver the Investigational Therapy Without Incurring the Protocol Suspension Rules
Count of participants that received the investigational therapy without incurring the protocol suspension rules. A stopping rule for safety was employed such that the study would be suspended if sufficient evidence indicated that the true grade 4-5 non-hematologic toxicity rate exceeded 10%.
Time frame: At 3-4 weeks after completion of study treatment
Overall and Complete Response Rates
Response was assessed per standard criteria (Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria fornon-Hodgkin's lymphomas. J Clin Oncol 1999;17:1244-1253.)
Time frame: 3-4 weeks after completion of study treatment
Hematologic and Non-hematologic Adverse Events.
Count of participants with grade 3/4 hematologic and non-hematologic adverse events.
Time frame: 3-4 weeks after completion of study treatment
Peripheral Blood Stem Cell Collection
Count of patients that attempted and had successful autologous peripheral blood stem cell (PBSC) collection.
Time frame: Up to 12 weeks
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