Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma

Status: Recruiting
Phase: Phase 2
Diagnosis: Brain/Neuro Cancer: Newly Diagnosed
NCT ID: NCT01511562 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-440

 

RATIONALE: Giving chemotherapy before an autologous stem cell transplant stops the growth of cancer cells by stopping them from dividing or killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy or radiation therapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. PURPOSE: This randomized phase II trial studies how well combination chemotherapy given together with autologous stem cell transplant works compared to combination chemotherapy alone in treating patients with central nervous system B-cell lymphoma.

 

Conducting Institutions:
Massachusetts General Hospital, Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Tracy Batchelor, MD, Massachusetts General Hospital

Site-responsible Investigators:
Lakshmi Nayak M.D., Dana Farber Cancer Institute

Contacts:
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100
Dana-Farber Cancer Institute: Lisa Doherty, ldoherty1@partners.org

Eligibility Criteria

DISEASE CHARACTERISTICS: - Diagnosis of primary central nervous system (CNS) diffuse large B-cell lymphoma confirmed by one of the following: - Brain biopsy or resection - Cerebrospinal fluid - Vitreous fluid - No evidence or history of non-Hodgkin lymphoma (NHL) outside of CNS - No isolated ocular lymphoma or isolated leptomeningeal lymphoma - At least one measurable, contrast-enhancing brain lesion (≥ 1 cm in length) PATIENT CHARACTERISTICS: - Karnofsky performance status ≥ 30% (≥ 50% for patients ages 60-70 years) - Adequate cardiac function (left ventricular ejection fraction [LVEF] ≥ 50%) and pulmonary function (corrected diffusion capacity of carbon monoxide [DLCO] ≥ 60% predicted) - Pregnant or nursing patients may not be enrolled; women of childbearing potential must have a negative serum or urine pregnancy test 10-14 days prior to registration; in addition, women and men of childbearing potential must commit to use an effective form of contraception throughout their participation in this study due to the teratogenic potential of the therapy utilized in this trial; appropriate methods of birth control include abstinence, oral contraceptives, implantable hormonal contraceptives, or double barrier method (diaphragm plus condom) - Negative human immunodeficiency virus (HIV) serology - Negative hepatitis B virus (HBV) and hepatitis C virus (HCV) serology (unless HBV antibody [HBsAb]-positive patient has recently received HBV vaccine, in this case HBcAb should be negative) - Absolute neutrophil count (ANC) ≥ 1500/mcL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2 times upper limit of normal (ULN) - Total bilirubin ≤ 3 mg/dL - Creatinine clearance ≥ 50 mL/min - Platelet count ≥ 100,000/mcL PRIOR CONCURRENT THERAPY: - No prior chemotherapy or radiation therapy for lymphoma - No history of organ transplantation or ongoing immunosuppressant therapy - No concurrent palliative radiotherapy
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