Vaccine Therapy and Sargramostim Compared With Placebo and Sargramostim Following Rituximab in Treating Patients With Non-Hodgkin's Lymphoma
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 GM-CSF increase the number of immune cells found in bone marrow and peripheral blood. It is not yet known whether combining rituximab and GM-CSF with vaccine therapy may cause a stronger immune response and kill more cancer cells.
PURPOSE: This randomized phase III trial is studying giving rituximab and GM-CSF together with vaccine therapy and comparing it to giving rituximab and GM-CSF alone in treating patients with newly diagnosed, relapsed, or refractory B-cell non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine Biological: rituximab Biological: sargramostim |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Phase III, Randomized, Double Blind, Placebo-Controlled Trial of Favldand GM-CSF Versus Placebo and GM-CSF Following Rituximab in Subjects With Follicular B-Cell Non-Hodgkin's Lymphoma |
- Time to progression after 248 patients have progressed [ Designated as safety issue: No ]
- Response rate improvement after 248 patients have progressed [ Designated as safety issue: No ]
- Overall complete response rate by modified Cheson Criteria after 248 patients have progressed [ Designated as safety issue: No ]
- Duration of response by modified Cheson Criteria after 248 patients have progressed [ Designated as safety issue: No ]
- Safety by Common Toxicity Criteria (CTC) after 248 patients have progressed [ Designated as safety issue: Yes ]
| Study Start Date: | July 2004 |
OBJECTIVES:
Primary
- Compare time to disease progression in patients with grade 1, 2, or 3 follicular B-cell non-Hodgkin's lymphoma who respond (i.e., complete or partial response, or stable disease) to treatment with rituximab and are then treated with sargramostim (GM-CSF) with vs without autologous immunoglobulin idiotype-KLH conjugate vaccine.
Secondary
- Compare response rate improvement in patients treated with these regimens.
- Compare overall complete response rate in patients treated with these regimens.
- Compare duration of response in patients treated with these regimens.
- Determine the safety of these regimens in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to prior treatment (yes vs no) and response to rituximab during study (complete response [CR] or partial response [PR] vs stable disease [SD]).
All patients receive rituximab IV once weekly for 4 weeks. Five weeks after the last dose of rituximab, patients are assessed for response. Patients with progressive disease are removed from the study and do not undergo randomization. Patients with a CR, PR, or SD are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine subcutaneously (SC) on day 1. Patients also receive sargramostim (GM-CSF) SC on days 1-4.
- Arm II: Patients receive placebo SC on day 1. Patients also receive GM-CSF SC on days 1-4.
In both arms, treatment repeats monthly for 6 months in the absence of unacceptable toxicity or clinically significant progressive disease. After the first 6 months, patients with a CR, PR, or SD may continue to receive treatment (per treatment arm as above) every 2 months for 1 year (total of 6 doses) and then every 3 months thereafter in the absence of disease progression.
Patients are followed every 3 months for 2 years and then every 6 months until disease progression.
PROJECTED ACCRUAL: A total of 342 evaluable patients (171 per treatment arm) will be accrued for this study within 18 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed follicular B-cell non-Hodgkin's lymphoma (NHL)
- Grade 1, 2, or 3
Meets 1 of the following criteria for treatment with rituximab:
- Treatment naïve
- Relapsed or refractory disease after prior chemotherapy
- Relapsed after a prior documented response (i.e., complete or partial response) to rituximab of at least 6 months duration
- Tumor accessible for biopsy OR existing biopsy material (taken within the past 6 months) suitable for vaccine preparation
- Measurable or evaluable disease after tumor tissue procurement for vaccine production
No more than 2 prior treatment regimens for NHL
Single regimens include any of the following:
- Maintenance rituximab
- Rituximab administered once weekly for 8 courses
- Cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) plus rituximab* NOTE: *CHOP followed by rituximab at time of relapse is considered 2 treatment regimens
- No history of CNS lymphoma or meningeal lymphomatosis
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Absolute granulocyte count ≥ 1,500/mm^3
- Platelet count ≥ 75,000/mm^3 (unless related to bone marrow involvement by lymphoma)
- Hemoglobin ≥ 10g/dL
Hepatic
- Not specified
Renal
- Not specified
Cardiovascular
- No congestive heart failure
Pulmonary
- No compromised pulmonary function
Immunologic
- HIV negative
- No prior allergic response to GM-CSF
- No active bacterial, viral, or fungal infection
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No psychiatric disorder that would preclude study participation
- No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No other serious nonmalignant disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
Biologic therapy
- See Disease Characteristics
- See Chemotherapy
- At least 4 weeks since prior immunotherapy
- No prior radiolabeled anti-lymphoma antibody (e.g., iodine I 131 tositumomab or ibritumomab tiuxetan)
- No prior autologous or allogeneic stem cell transplantation
- No prior lymphoma-specific idiotype immunotherapy (e.g., Id vaccine)
- No prior investigational vaccine or immunotherapeutic containing keyhole limpet hemocyanin (KLH)
Chemotherapy
- See Disease Characteristics
- At least 4 weeks since prior chemotherapy
- More than 9 months since prior fludarabine
- More than 2 years since prior chemotherapy/rituximab combination therapy (e.g., CHOP/rituximab or cyclophosphamide, vincristine, and prednisone [CVP]/rituximab)
- No more than 6 total prior treatment courses with fludarabine
Endocrine therapy
- No concurrent steroids for allergic reaction to sargramostim (GM-CSF)
Radiotherapy
- See Biologic therapy
- At least 4 weeks since prior radiotherapy
Surgery
- Not specified
Other
- At least 4 weeks since prior experimental therapy
- No concurrent systemic immunosuppressive therapy
- No other concurrent anti-lymphoma therapy
Contacts and Locations
Show 60 Study Locations| Study Chair: | John F. Bender, PharmD | Favrille |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00089115 History of Changes |
| Other Study ID Numbers: | CDR0000378046, FAV-ID-06, FAV-WIRB-20040335, CWRU-FVID-1404 |
| Study First Received: | August 4, 2004 |
| Last Updated: | February 4, 2010 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
contiguous stage II grade 1 follicular lymphoma contiguous stage II grade 2 follicular lymphoma contiguous stage II grade 3 follicular lymphoma noncontiguous stage II grade 1 follicular lymphoma noncontiguous stage II grade 2 follicular lymphoma noncontiguous stage II grade 3 follicular lymphoma stage I grade 1 follicular lymphoma stage I grade 2 follicular lymphoma stage I grade 3 follicular lymphoma |
stage III grade 1 follicular lymphoma stage III grade 2 follicular lymphoma stage III grade 3 follicular lymphoma stage IV grade 1 follicular lymphoma stage IV grade 2 follicular lymphoma stage IV grade 3 follicular lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases 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