Gemcitabine Hydrochloride, Carboplatin, Dexamethasone, and Rituximab in Treating Patients With Previously Treated Lymphoid Malignancies
Condition: Adult Nasal Type Extranodal NK/T-cell Lymphoma; Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Cutaneous B-cell Non-Hodgkin Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Hepatosplenic T-cell Lymphoma; Intraocular Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Noncutaneous Extranodal Lymphoma; Peripheral T-cell Lymphoma; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Small Lymphocytic Lymphoma; Small Intestine Lymphoma; Splenic Marginal Zone Lymphoma; Testicular Lymphoma; Waldenstrom Macroglobulinemia
MeSH terms: Burkitt Lymphoma; Mycoses; Lymphoma; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Hodgkin Disease; Lymphoma, Mantle-Cell; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma; Mycosis Fungoides; Sezary Syndrome; Leukemia, T-Cell; Lymphoma, T-Cell, Cutaneous; Waldenstrom Macroglobulinemia; Leukemia-Lymphoma, Adult T-Cell; Lymphoma, Large-Cell, Anaplastic; Lymphomatoid Granulomatosis; Lymphoma, Extranodal NK-T-Cell; Intraocular Lymphoma; Immunoblastic Lymphadenopathy; Recurrence
Intervention: gemcitabine hydrochloride; carboplatin; dexamethasone; rituximab
Intervention description: Given IV; Given IV; Given PO; Given IV in CD20-POSITIVE LYMPHOMAS cases
Intervention MeSH terms: Dexamethasone; Rituximab; Carboplatin; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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
    

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