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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003716
First Posted: December 5, 2003
Last Update Posted: March 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention Phase
Lymphoma Biological: rituximab Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Trial of Rituximab in Patients With B-Cell Lymphoproliferative Disorders Associated With Pharmacologic Immunosuppression

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment: 15
Study Start Date: March 1998
Detailed Description:

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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003716


Locations
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305-5408
Sponsors and Collaborators
Stanford University
Investigators
Study Chair: Sandra J. Horning, MD Stanford University
  More Information

ClinicalTrials.gov Identifier: NCT00003716     History of Changes
Other Study ID Numbers: CDR0000066825
SUMC-03
NCI-V98-1508
First Submitted: November 1, 1999
First Posted: December 5, 2003
Last Update Posted: March 20, 2012
Last Verified: June 2002

Keywords provided by National Cancer Institute (NCI):
childhood Burkitt lymphoma
childhood immunoblastic large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult Burkitt lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult Burkitt lymphoma
stage IV childhood small noncleaved cell lymphoma
stage IV childhood large cell lymphoma
recurrent childhood small noncleaved cell lymphoma
recurrent childhood large cell lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents