Lymphoma Clinical Trial
Official title:
Pilot Study of Rituximab, High Dose Cyclophosphamide, and GM-CSF Based Immunotherapy for Relapsed Hodgkin's Lymphoma
Verified date | February 2019 |
Source | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 31 |
Est. completion date | January 2013 |
Est. primary completion date | January 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Grade 3-5 Adverse Events | Number of participants who experienced at least one grade 3-5 adverse event by CTCAE 3.0 that was attributed to protocol intervention. | Up to 36 months | |
Primary | Percentage of Participants With an Increase in Frequency of LMP2-specific CD8+ T Cells | Percentage of participants with an increase in frequency of LMP2-specific CD8+ T cells. Increase in frequency is defined as at least one order of magnitude higher than baseline measurement. | Change from 3 months to 6 months | |
Secondary | Survival | Median number of months that participants were alive (overall survival) and alive without disease relapse or new diagnosis of myelodysplasia or acute leukemia (event-free survival). | Up to 6 years | |
Secondary | Days to Neutrophil and Platelet Engraftment | Median number of days to absolute neutrophil count (ANC) >= 500/mcL and platelet count >=20000/mcL. | Up to 46 days |
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