Rituximab, Autologous Vaccine Therapy, and Sargramostim in Treating Patients With Recurrent or Refractory Follicular B-Cell Lymphoma
Recruitment status was Active, not recruiting
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Purpose
RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Vaccines made from a person's cancer cells may make the body build an immune response to kill cancer cells. Colony-stimulating factors such as sargramostim increase the number of immune cells found in bone marrow or peripheral blood. Combining rituximab with autologous vaccine therapy and sargramostim may cause a stronger immune response and kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining rituximab with autologous vaccine therapy and sargramostim in treating patients who have recurrent or refractory follicular B-cell lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine Biological: rituximab Biological: sargramostim |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Trial of Rituxan Plus FavId (Tumor-Specific Idiotype-KLH) and GM-CSF Immunotherapy in Patients With Grade 1 or 2 Follicular B-Cell Lymphoma |
| Study Start Date: | January 2003 |
OBJECTIVES:
- Compare the 9-month objective response rate of patients with recurrent or refractory grade I or II follicular B-cell lymphoma treated with rituximab, autologous immunoglobulin idiotype-KLH conjugate vaccine, and sargramostim (GM-CSF) vs historical control patients who received rituximab alone.
- Compare the median duration of response and median time to progression in patients treated with this regimen vs historical controls.
- Determine the immune response (humoral and/or cellular) of patients treated with this regimen.
- Determine the safety of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive rituximab IV once weekly for 4 weeks. Beginning at least 8 weeks later, patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine (Id-KLH) and sargramostim (GM-CSF) subcutaneously once monthly for a total of 6 months in the absence of disease progression or unacceptable toxicity.
Patients who achieve an objective response (complete response or partial response) or stable disease may continue to receive Id-KLH and GM-CSF every other month for a total of 6 doses and then every 3 months in the absence of disease progression.
Patients are followed every 6 months for at least 2 years.
PROJECTED ACCRUAL: A total of 44 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 grade I or II follicular B-cell lymphoma
Must meet one of the following criteria for relapsed/refractory disease:
- Relapsed or refractory after prior chemotherapy
Relapsed after prior rituximab
- Rituximab may have been given as second-line therapy after an initial response to chemotherapy or in combination with chemotherapy as initial therapy
No more than 2 prior treatment regimens
- Cyclophosphamide/doxorubicin/prednisone/vincristine (CHOP) and rituximab is considered 1 prior treatment regimen
- CHOP followed by rituximab at initial relapse is considered 2 prior treatment regimens
Measurable disease after node biopsy
- At least 1 bidimensionally measurable lesion
- If only 1 measurable lesion remains after biopsy, it must be at least 2 cm in each dimension
- Tumor accessible for biopsy or prior recent biopsy material available
- No known history of CNS lymphoma or meningeal lymphomatosis
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count at least 1,000/mm^3
- Lymphocyte count less than 5,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 2.0 mg/dL
- AST and ALT no greater than 2 times upper limit of normal
Renal
- Creatinine no greater than 1.5 mg/dL
Cardiovascular
- No congestive heart failure
Pulmonary
No compromised pulmonary function that would preclude study participation, including any of the following:
- Active asthma
- Chronic obstructive pulmonary disorder
- Pneumonitis
- Bronchiolitis obliterans
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- HIV negative
- No active uncontrolled bacterial, viral, or fungal infection
- No other concurrent nonmalignant disease that would preclude study participation
- No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- No prior tumor-specific idiotype immunotherapy using the identical idiotype
Chemotherapy
- See Disease Characteristics
- More than 9 months since prior fludarabine
Endocrine therapy
- No concurrent high-dose steroid therapy
Radiotherapy
- Not specified
Surgery
- Not specified
Other
- More than 30 days since prior investigational drugs
- No concurrent immunosuppressive therapy
- No other concurrent anticancer therapy
Contacts and Locations| United States, Ohio | |
| Ireland Cancer Center | |
| Cleveland, Ohio, United States, 44106 | |
| Study Chair: | Omer N. Koc, MD | Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00060164 History of Changes |
| Other Study ID Numbers: | CDR0000299533, CWRU-FVID-1402, FAV-ID-04 |
| Study First Received: | May 6, 2003 |
| Last Updated: | February 12, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Immunoglobulin Idiotypes |
Immunoglobulins Antibodies Rituximab Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013