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Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00036855 |
RATIONALE: 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.
PURPOSE: 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.
Condition | Intervention | Phase |
---|---|---|
Lymphoma Lymphoproliferative Disorder |
Drug: filgrastim Drug: indium In 111 ibritumomab tiuxetan Drug: rituximab Drug: yttrium Y 90 ibritumomab tiuxetan Procedure: peripheral blood stem cell transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase I Study Of Yttrium-Ibritumomab Tiuxetan (90Y Zevalin, Yttrium (90)-Anti-CD20, NSC # 710085) Preceded By Rituximab In Children With Recurrent/Refractory CD20 Positive Lymphoma |
Study Start Date: | June 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter, dose-escalation study of yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8). Patients are assigned to 1 of 2 groups.
Cohorts of 3-6 patients in each subgroup (A1, A2, and A3) receive escalating doses of IDEC-Y2B8 until the maximum tolerated dose (MTD) is determined (subgroup A1 closed as of 10/8/04). The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity (DLT).
Some patients receive autologous PBSC IV over 30-60 minutes on day 35.
If the DLT in group A is purely hematological, cohorts of 3-6 patients in group B receive escalating doses of IDEC-Y2B8 until the MTD is determined. The MTD is defined as in group A.
Patients in both groups are followed at days 63, 90, 180, 365, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 6-36 patients (6-24 for group A and 3-12 for group B) will be accrued for this study.
Ages Eligible for Study: | up to 21 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Refractory to conventional therapy
Meets one of the following criteria for bone marrow reserve:
Good marrow reserve, defined by both of the following:
No prior extensive radiotherapy, defined by any of the following:
Poor marrow reserve, defined by either or both of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Prior SCT allowed if the following criteria are met:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | Mitchell S. Cairo, MD | Herbert Irving Comprehensive Cancer Center |
Study ID Numbers: | CDR0000069331, COG-ADVL0013 |
Study First Received: | May 13, 2002 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00036855 |
Health Authority: | United States: Federal Government |
recurrent childhood lymphoblastic lymphoma recurrent/refractory childhood Hodgkin lymphoma AIDS-related peripheral/systemic lymphoma AIDS-related primary CNS lymphoma |
recurrent childhood small noncleaved cell lymphoma recurrent childhood large cell lymphoma post-transplant lymphoproliferative disorder |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Hodgkin's disease Rituximab Lymphoblastic lymphoma Small non-cleaved cell lymphoma Recurrence Central nervous system lymphoma, primary Antibodies, Monoclonal |
Lymphoma, large-cell Lymphatic Diseases Antibodies Hodgkin lymphoma, childhood Lymphoproliferative Disorders Lymphoma Hodgkin Disease Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Antirheumatic Agents Pharmacologic Actions |