A Phase II Study Evaluating the Efficacy of Gemcitabine, Carboplatin, and Dexamethasone and Rituximab for Previously Treated Lymphoid Malignancies
gemcitabine hydrochloride
+ carboplatin
+ dexamethasone
Plasmablastic Lymphoma+56
+ Lymphadenopathy
+ Bacterial Infections and Mycoses
Treatment Study
Summary
Study start date: August 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.55 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, United StatesSee the location