Rituximab and Cyclophosphamide Followed by Vaccine Therapy in Treating Patients With Relapsed Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT00134082|
Recruitment Status : Active, not recruiting
First Posted : August 24, 2005
Last Update Posted : November 6, 2017
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing. Vaccines made from another person's cancer cells may help the body build an effective immune response to kill cancer cells. Giving rituximab together with chemotherapy and vaccine therapy may kill more cancer cells
PURPOSE: This phase I/II trial is studying how well giving rituximab together with cyclophosphamide and vaccine therapy works in treating patients with relapsed Hodgkin lymphoma.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma||Biological: Hodgkin's antigens-GM-CSF-expressing cell vaccine Biological: filgrastim Biological: rituximab Drug: cyclophosphamide||Phase 1 Phase 2|
- Determine the safety and tolerability of rituximab and high-dose cyclophosphamide followed by vaccine therapy comprising an allogeneic vaccine that expresses Hodgkin's tumor antigens and sargramostim (GM-CSF) (KGEL vaccine) as salvage therapy in patients with relapsed Hodgkin lymphoma.
- Determine the immunologic response to this vaccine in these patients.
- Determine the 3-year relapse-free and overall survival of patients treated with this regimen.
- Determine the patterns of cellular immune reconstitution in patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive rituximab IV on days -10 and -7 and then on days 29, 36, 43, and 50 (weeks 4-7) and high-dose (transplant-dose) cyclophosphamide IV on days -3 to 0 without stem cell rescue. Patients receive filgrastim (G-CSF) subcutaneously once daily beginning on day 6 and continuing until blood counts recover. Patients also receive vaccine therapy comprising an allogeneic vaccine that expresses Hodgkin's tumor antigens and sargramostim (GM-CSF) (KGEL vaccine) intradermally on day 1, and weeks 4, 8, 12, 16, and 24.
After completion of high-dose cyclophosphamide, patients are followed every 3 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 25 patients will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Rituximab, High Dose Cyclophosphamide, and GM-CSF Based Immunotherapy for Relapsed Hodgkin's Lymphoma|
|Study Start Date :||July 2005|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||December 2018|
- Safety and tolerability
- Immunologic response
- Relapse-free survival at 3 years
- Overall survival at 3 years
- Patterns of cellular immune reconstitution
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): NCT00134082
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Study Chair:||Richard Ambinder, MD||Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|