Radiolabeled Monoclonal Antibody With or Without Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Lymphoma
Stopped early · Phase 1
Conditions studied: AIDS-related Peripheral/Systemic Lymphoma, AIDS-related Primary CNS Lymphoma, Post-transplant Lymphoproliferative Disorder, Recurrent Childhood Large Cell Lymphoma, Recurrent Childhood Lymphoblastic Lymphoma, Recurrent Childhood Small Noncleaved Cell Lymphoma, Recurrent/Refractory Childhood Hodgkin Lymphoma
In brief
Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy with or without peripheral stem cell transplantation in treating patients who have recurrent or refractory lymphoma. Radiolabeled monoclonal antibodies can locate cancer cells and deliver radioactive tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by anticancer therapy
Key facts
- Study ID
- NCT00036855
- Run by
- National Cancer Institute (NCI)
- People needed
- 36
- Starts
- 2002-06-01
- Last updated by the study team
- 2013-01-17
Who can join
Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
Where it is running
- Children's Oncology Group — Arcadia, California, United States
Full record on ClinicalTrials.gov
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