Rituximab and Cyclophosphamide Followed by Vaccine Therapy in Treating Patients With Relapsed Hodgkin Lymphoma
| Status: | Completed |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 120 |
| Updated: | 2/28/2019 |
| Start Date: | November 2005 |
| End Date: | January 2013 |
Pilot Study of Rituximab, High Dose Cyclophosphamide, and GM-CSF Based Immunotherapy for Relapsed Hodgkin's Lymphoma
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.
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.
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.
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.
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
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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