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Monoclonal Antibody Therapy in Treating Patients With Lymphoproliferative Disorder Associated With Immunosuppression Therapy



Monoclonal Antibody Therapy in Treating Patients With Lymphoproliferative Disorder Associated With Immunosuppression Therapy

For Condition: recurrent adult immunoblastic large cell lymphoma,recurrent adult diffuse small noncleaved cell/Burkitt's lymphoma,Burkitt's Lymphoma,childhood immunoblastic large cell lymphoma,stage 4 adult immunoblastic large cell lymphoma,recurrent childhood large cell lymphoma,recurrent childhood small noncleaved cell lymphoma,stage 4 adult diffuse small noncleaved cell/Burkitt's lymphoma,stage 4 childhood large cell lymphoma,stage 4 childhood small noncleaved cell lymphoma
Status: No longer recruiting
Sponsor(s): Stanford University ,
Synopsis: RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of rituximab in treating patients who have lymphoproliferative disorder that is associated with immunosuppression therapy.
Details: OBJECTIVES: I. Evaluate the efficacy of rituximab in patients with B-cell lymphoproliferative disorders while under pharmacologic immune suppression for control of either allograft rejection or autoimmune disease. II. Evaluate the safety and direct toxicity of rituximab in this patient population, including the potential for opportunistic infections. III. Evaluate the secondary consequences of rituximab therapy in this population, including changes in the requirement for immunosuppressive drugs, effects on graft rejection, graft survival, and severity of autoimmune disease. PROTOCOL OUTLINE: Patients receive rituximab IV over several hours. Treatment repeats every week for 4 courses. Patients are followed every month for 6 months, and then every 3 months until relapse or 2 years. PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 1 year.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 3 Years/70 Years
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Polyclonal or monoclonal B-cell lymphoproliferative disorder while under pharmacologic immune suppression for control of either allograft rejection or autoimmune disease - Measurable disease as defined by one of the following: At least 1 tumor mass measuring 1.0 cm in largest dimension; Greater than 25% marrow involvement; Quantifiable extranodal disease - Expression of CD20 antigen confirmed by biopsy or fine needle aspirate - Progression of disease or stable disease following reduction of immunosuppressive medication and antiviral therapy - Inability to further reduce immunosuppressive medication --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas); No concurrent chemotherapy - Endocrine therapy: At least 2 weeks since change in dosing and type of immunosuppressive drugs unless due to progression of disease - Radiotherapy: At least 4 weeks since prior radiotherapy; No concurrent radiotherapy - Surgery: At least 4 weeks since prior major surgery (except diagnostic surgery) - Other: At least 30 days or 5 half-lives since other prior investigational drugs or whichever is longer --Patient Characteristics-- - Age: 3 to 70 - Performance status: Karnofsky 70-100% - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,000/mm3; Platelet count at least 50,000/mm3 - Hepatic: Not specified - Renal: Not specified - Cardiovascular: No congestive heart failure - Pulmonary: No pneumonitis - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 3 months after study; No serious nonmalignant disease; No active uncontrolled bacterial, viral, or fungal infections
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
SandraHorning,  Study Chair,  Stanford University

Stanford University Medical Center
Stanford,  California,  94305-5408
United States
 


Additional Information:
Study ID Numbers:
  CDR0000066825;  SUMC-03,NCI-V98-1508
Study Start Date: March 1998
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003716

Other Stage 4 Childhood Large Cell Lymphoma Studies:
1. Monoclonal Antibody Therapy in Treating Patients With Recurrent Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma

2. Combination Chemotherapy in Treating Children With Acute Lymphoblastic Leukemia, Osteosarcoma, or Non-Hodgkin's Lymphoma

3. Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation in Treating Children With Recurrent or Refractory Hodgkin's or Non-Hodgkin's Lymphoma

4. Chemotherapy in Treating Young Patients With Recurrent or Refractory Meningeal Leukemia, Lymphoma, or Solid Tumors

5. Comparison of Combination Chemotherapy Regimens in Treating Children Who Have Anaplastic Large Cell Lymphoma

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Monoclonal Antibody Therapy in Treating Patients With Lymphoproliferative Disorder Associated With Immunosuppression Therapy

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