Pilot Study of Rituximab, High Dose Cyclophosphamide, and GM-CSF Based Immunotherapy for Relapsed Hodgkin's Lymphoma
18 Years
N/A
Both
Lymphoma
Trial Information
Pilot Study of Rituximab, High Dose Cyclophosphamide, and GM-CSF Based Immunotherapy for Relapsed Hodgkin's 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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety and tolerability
Safety Issue:
Yes
Principal Investigator
Yvette L. Kasamon, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
J0528 , CDR0000441037
NCT ID:
NCT00134082
Start Date:
July 2005
Completion Date:
Related Keywords:
- Lymphoma
- recurrent adult Hodgkin lymphoma
- Hodgkin Disease
- Lymphoma
Name | Location |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
