Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Children's Oncology Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00066469 |
RATIONALE: Drugs used in chemotherapy such as cyclophosphamide, prednisone, and methylprednisolone use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining cyclophosphamide and either prednisone or methylprednisolone with rituximab may be effective in treating lymphoproliferative disease following organ transplantation.
PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide and either prednisone or methylprednisolone with rituximab in treating patients who have Epstein-Barr virus-positive lymphoproliferative disease following organ transplantation.
Condition | Intervention | Phase |
---|---|---|
Lymphoproliferative Disorder |
Drug: cyclophosphamide Drug: methylprednisolone Drug: prednisone Drug: rituximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of the Combination of Cyclophosphamide, Prednisone and Rituximab (CPR) in Children, Adolescents and Young Adults With CD20 Positive Post-Transplant Lymphoproliferative Disease (PTLD) Following Solid Organ Transplantation (SOT) |
Estimated Enrollment: | 60 |
Study Start Date: | April 2004 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
After finishing study treatment, patients are followed periodically for at least 5 years.
PROJECTED ACCRUAL: A total of 60 patients (50 with non-fulminant post-transplant lymphoproliferative disease [PTLD] and 10 fulminant PTLD) will be accrued for this study within 2.5-3 years.
Ages Eligible for Study: | up to 30 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed post-transplant lymphoproliferative disease (PTLD)
Presents with 1 of the following:
Fulminant PTLD (F-PTLD)
Evidence of multiple organ involvement/failure, including at least 2 of the following:
Non-fulminant PTLD (NF-PTLD)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
NF-PTLD patients:
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Study Chair: | Thomas G. Gross, MD, PhD | Nationwide Children's Hospital |
Study ID Numbers: | CDR0000316241, COG-ANHL0221 |
Study First Received: | August 6, 2003 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00066469 |
Health Authority: | United States: Federal Government |
post-transplant lymphoproliferative disorder |
Post-transplant lymphoproliferative disease Prednisone Lymphatic Diseases Immunoproliferative Disorders Methylprednisolone Rituximab |
Prednisolone Methylprednisolone acetate Prednisolone acetate Cyclophosphamide Lymphoproliferative Disorders Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics Hormones Glucocorticoids |
Protective Agents Neuroprotective Agents Immunosuppressive Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Myeloablative Agonists Peripheral Nervous System Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Central Nervous System Agents Alkylating Agents |