Rituximab and Cyclophosphamide Followed by Vaccine Therapy in Treating Patients With Relapsed Hodgkin Lymphoma
Recruitment status was Active, not recruiting
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: Hodgkin's antigens-GM-CSF-expressing cell vaccine Biological: filgrastim Biological: rituximab Drug: cyclophosphamide |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study of Rituximab, High Dose Cyclophosphamide, and GM-CSF Based Immunotherapy for Relapsed Hodgkin's Lymphoma |
- Safety and tolerability [ Designated as safety issue: Yes ]
- Immunologic response [ Designated as safety issue: No ]
- Relapse-free survival at 3 years [ Designated as safety issue: No ]
- Overall survival at 3 years [ Designated as safety issue: No ]
- Patterns of cellular immune reconstitution [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2005 |
| Estimated Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
| Baltimore, Maryland, United States, 21231-2410 | |
| Study Chair: | Yvette L. Kasamon, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Yvette Leslie Kasamon, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
| ClinicalTrials.gov Identifier: | NCT00134082 History of Changes |
| Other Study ID Numbers: | J0528 , CDR0000441037, P50CA096888, P30CA006973, JHOC-J0528 |
| Study First Received: | August 22, 2005 |
| Last Updated: | April 21, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
recurrent adult Hodgkin lymphoma |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cyclophosphamide Rituximab Lenograstim Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 23, 2013