Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma
AIDS-related Peripheral/Systemic Lymphoma, AIDS-related Primary CNS Lymphoma, Post-transplant Lymphoproliferative Disorder
About this trial
This is an interventional treatment trial for AIDS-related Peripheral/Systemic Lymphoma
Eligibility Criteria
Inclusion Criteria: Histologically confirmed and immunophenotypically (CD20)-positive lymphoma at original diagnosis, progression, or relapse Refractory to conventional therapy First recurrent/refractory CD20-positive non-Hodgkin's lymphoma (NHL) allowed if ineligible for or refused regimens with known curative potential (high-dose chemotherapy plus bone marrow transplantation) (if available) Second or third progression and/or recurrence of NHL Second or third relapse/refractory CD20-positive Hodgkin's lymphoma CD20-positive, post-transplantation lymphoproliferative lymphoma that is medically refractory (decreased immunosuppression) to rituximab and/or chemotherapy Medically refractory, HIV-associated, CD20-positive NHL Recurrent/refractory CD20-positive lymphoblastic lymphoma Autologous peripheral blood stem cells (PBSC) collected, selected for a minimum of 2 x 10^6 CD34-positive cells per kg, and cryopreserved before study entry Meets one of the following criteria for bone marrow reserve: Good marrow reserve, defined by both of the following: No prior myeloablative stem cell transplantation (SCT) No prior extensive radiotherapy, defined by any of the following: Prior total body irradiation Prior radiotherapy dose of 3,600 cGy or more to cranio-spinal axis Prior radiotherapy to 50% or more of bone marrow Poor marrow reserve, defined by either or both of the following: Prior myeloablative SCT Prior extensive radiotherapy Performance status - Lansky 50-100% (age 10 and under) Performance status - Karnofsky 50-100% (age 11 to 21) At least 2 months Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 for patients with poor marrow reserve (transfusion independent) Platelet count ≥ 150,000 for patients with good marrow reserve (transfusion independent) Hemoglobin ≥ 8.0 g/dL (transfusion allowed) Bilirubin ≤ 1.5 times upper limit of normal (ULN) ALT ≤ 5 times ULN Albumin ≥ 2 g/dL Creatinine normal Creatinine clearance or glomerular filtration rate ≥ 70 mL/min Shortening fraction ≥ 27% by echocardiogram Ejection fraction ≥ 50% by MUGA No dyspnea at rest No exercise intolerance Oxygen saturation (SpO_2) > 94% by pulse oximetry (if there is a clinical indication for SpO_2 assessment) Not pregnant or nursing Negative pregnancy test No documented infection that is unresponsive to appropriate antibiotic, antiviral, or antifungal therapy No grade 2 or greater CNS toxicity Seizure disorder allowed if well controlled and on anticonvulsants See Disease Characteristics Recovered from prior immunotherapy At least 1 week since prior antineoplastic biologic agents Prior SCT allowed if the following criteria are met: At least 60 days since prior SCT Full hematopoietic reconstitution post-SCT No evidence of active acute or chronic graft-versus-host disease if post- allogeneic SCT No concurrent sargramostim (GM-CSF) See Disease Characteristics At least 3 weeks since prior myelosuppressive chemotherapy (4 weeks for nitrosourea) and recovered See Disease Characteristics Recovered from prior radiotherapy No concurrent medications that would interact with the study drug
Sites / Locations
- Children's Oncology Group
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group A (no planned PBSC support)
Group B (planned PBSC support)
Patients receive rituximab IV over 4-6 hours followed by IDEC-In2B8 IV over 10 minutes on day 0 and undergo whole body imaging. Patients may then receive rituximab IV over 4-6 hours followed by IDEC-Y2B8 IV over 10 minutes on day 7. Some patients receive autologous PBSC IV over 30-60 minutes on day 35.
Patients receive rituximab, IDEC-In2B8, and IDEC-Y2B8 as in group A. Patients also receive autologous PBSC IV over 30-60 minutes on day 21 and G-CSF subcutaneously beginning on day 22 and continuing until blood counts recover or day 35.