Overview
Reduced-Intensity Regimen Before Allogeneic Transplant for Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma
Status:
Terminated
Terminated
Trial end date:
2011-05-01
2011-05-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
RATIONALE: Photopheresis allows patient white blood cells to be treated with ultraviolet (UV) light and drugs outside the body to inactivate T cells. Pentostatin may suppress the immune system and reduce the chance of developing graft-versus-host disease (GVHD) following bone marrow transplantation. Combining photopheresis with pentostatin and total-body irradiation may be effective in killing cancer cells before bone marrow transplantation. PURPOSE: This phase II trial is studying how well giving photophoresis together with pentostatin and total-body irradiation as a reduced-intensity regimen before allogeneic bone marrow transplantation works in treating patients with relapsed non-Hodgkin's or Hodgkin's lymphoma.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Eastern Cooperative Oncology GroupCollaborator:
National Cancer Institute (NCI)Treatments:
Cyclosporine
Cyclosporins
Methotrexate
Mycophenolate mofetil
Mycophenolic Acid
Pentostatin
Criteria
Inclusion Criteria:- Non-Hodgkin's or Hodgkin's lymphoma that has relapsed following either a course of
high dose chemotherapy or autologous stem cell transplantation.
- >= 90 days from prior transplant.
- Have a suitable human leukocyte antigen (HLA)-matched related bone marrow donor or a
compatible matched unrelated bone marrow donor by molecular typing at HLA A, B, C, D,
DR.
- Physically and psychologically capable of undergoing bone marrow transplantation and
its attendant period of strict isolation.
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Be able to receive 400 cGy Total Body Irradiation (TBI).
- Pulmonary function tests: Diffusing capacity or Transfer factor of the lung for carbon
monoxide (DLCO) >= 50% predicted, the forced expiratory volume in 1 second (FEV1) >=
50% predicted.
- Left ventricular ejection fraction (LVEF) at least 45% by Multi Gated Acquisition Scan
(MUGA) or echocardiogram.
- Renal function: creatinine clearance > 50 ml/min.
- Liver function tests: < 3 x Upper Limit of Normal (ULN). Liver function test include
serum glutamic oxaloacetic transaminase (SGOT) (Aspartate transaminase (AST)), Serum
Glutamic Pyruvate Transaminase (SGPT) (Alanine transaminase (ALT)), and bilirubin.
Exclusion Criteria:
- Human immunodeficiency virus positive (HIV+) patients (test positive for P21
antibodies to HIV).
- Evidence of active infection (have received parenteral antibiotics <= 2 weeks prior to
registration).
- Pregnant or breast-feeding women.
- Curable with any other therapeutic interventions.