Gemcitabine Hydrochloride, Carboplatin, Dexamethasone, and Rituximab in Treating Patients With Previously Treated Lymphoid Malignancies

• Status: Completed
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fred Hutchinson Cancer Research Center; Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
• Collaborator: National Cancer Institute (NCI)
• Treatments: BB 1101; Carboplatin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Gemcitabine; Rituximab

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