Rituximab and Cyclophosphamide Followed by Vaccine Therapy in Treating Patients With Relapsed Hodgkin Lymphoma
This trial is active, not recruiting.
|Treatments||hodgkin's antigens-gm-csf-expressing cell vaccine, filgrastim, rituximab, cyclophosphamide|
|Phase||phase 1/phase 2|
|Sponsor||Sidney Kimmel Comprehensive Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||July 2005|
|End date||October 2017|
|Trial size||30 participants|
|Trial identifier||NCT00134082, J0528 , CDR0000441037, JHOC-J0528, NA_00035358, P30CA006973, P50CA096888|
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.
|Intervention model||single group assignment|
Safety and tolerability
Relapse-free survival at 3 years
Overall survival at 3 years
Patterns of cellular immune reconstitution
Male or female participants from 18 years up to 120 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed classical Hodgkin's lymphoma - Relapsed disease with achievement of at least a partial response or a metabolic response to most recent salvage therapy - No primary induction failure, defined as disease progression during or within 2 months after completion of first-line therapy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - ECOG 0-1 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count ≥ 1,000/mm^3 - Platelet count ≥ 75,000/mm^3 Hepatic - Bilirubin ≤ 2.0 mg/dL* NOTE: *Unless due to lymphoma or Gilbert's syndrome Renal - Creatinine ≤ 2.0 mg/dL Cardiovascular - Ejection fraction ≥ 45% by echocardiogram or MUGA Pulmonary - DLCO ≥ 50% of predicted (corrected for alveolar volume) Immunologic - No known HIV positivity - No active infection requiring oral or IV antibiotics - No autoimmune or other disease requiring long-term systemic steroids or other long-term immunosuppressants Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - Able to tolerate high-dose therapy - No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior bone marrow transplantation Endocrine therapy - Not specified Radiotherapy - Concurrent radiotherapy for disease progression after high-dose cyclophosphamide allowed at the discretion of the principal investigator Surgery - Not specified
|Official title||Pilot Study of Rituximab, High Dose Cyclophosphamide, and GM-CSF Based Immunotherapy for Relapsed Hodgkin's Lymphoma|
|Description||OBJECTIVES: Primary - 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. Secondary - 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.|
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