Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/4/2018 |
| Start Date: | July 2004 |
| End Date: | March 2019 |
A Phase II Trial Using a Universal GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) in the Formulation of Autologous Tumor Cell-Based Vaccines for Patients With Mantle Cell Lymphoma
RATIONALE: Vaccines made from gene-modified cells and a person's cancer cells may make the
body build an effective immune response to kill cancer cells. Interleukin-2 (IL-2) may
stimulate the white blood cells to kill cancer cells. Giving booster vaccinations may make a
stronger immune response and prevent or delay the recurrence of cancer. Drugs used in
chemotherapy work in different ways to stop the growth of cancer cells, either by killing the
cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)
may kill more cancer cells. Giving vaccine therapy together with IL-2 after combination
chemotherapy may be a more effective treatment for mantle cell lymphoma.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with IL-2
after combination chemotherapy works in treating patients with relapsed or de novo stage II,
stage III, or stage IV mantle cell lymphoma.
body build an effective immune response to kill cancer cells. Interleukin-2 (IL-2) may
stimulate the white blood cells to kill cancer cells. Giving booster vaccinations may make a
stronger immune response and prevent or delay the recurrence of cancer. Drugs used in
chemotherapy work in different ways to stop the growth of cancer cells, either by killing the
cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy)
may kill more cancer cells. Giving vaccine therapy together with IL-2 after combination
chemotherapy may be a more effective treatment for mantle cell lymphoma.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with IL-2
after combination chemotherapy works in treating patients with relapsed or de novo stage II,
stage III, or stage IV mantle cell lymphoma.
Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration
at the discretion of the individual clinician. Evaluation for response was performed 1 month
after completing chemotherapy, and included computed tomography (CT) scan, bone marrow
biopsy, endoscopy, and colonoscopy. Minimal residual disease (MRD) was assessed qualitatively
on bone marrow specimens using polymerase chain reaction (PCR) with standardized primers for
evaluation for B-cell receptor gene rearrangement. Responses were defined according to
revised Cheson criteria. Patients with successful lymph node harvest who had obtained
complete or partial response could proceed to bystander vaccination.
The GM.CD40L bystander vaccine administered intradermally into the bilateral axillary and
inguinal nodal basins via eight separate injections (0.125 ml / injection). Low dose IL-2
(0.5 x 10^6 units) was given subcutaneously twice daily for 14 days following vaccination.
Patients were restaged with CT and/or CT/PET and bone marrow biopsy every 6 months, beginning
from the last date of chemotherapy. Follow-up bone marrow biopsy evaluation included an
assessment for MRD as described above. Patients without disease progression or toxicity
attributable to the vaccine were eligible for 4 monthly booster vaccines at 12 months and 24
months.
at the discretion of the individual clinician. Evaluation for response was performed 1 month
after completing chemotherapy, and included computed tomography (CT) scan, bone marrow
biopsy, endoscopy, and colonoscopy. Minimal residual disease (MRD) was assessed qualitatively
on bone marrow specimens using polymerase chain reaction (PCR) with standardized primers for
evaluation for B-cell receptor gene rearrangement. Responses were defined according to
revised Cheson criteria. Patients with successful lymph node harvest who had obtained
complete or partial response could proceed to bystander vaccination.
The GM.CD40L bystander vaccine administered intradermally into the bilateral axillary and
inguinal nodal basins via eight separate injections (0.125 ml / injection). Low dose IL-2
(0.5 x 10^6 units) was given subcutaneously twice daily for 14 days following vaccination.
Patients were restaged with CT and/or CT/PET and bone marrow biopsy every 6 months, beginning
from the last date of chemotherapy. Follow-up bone marrow biopsy evaluation included an
assessment for MRD as described above. Patients without disease progression or toxicity
attributable to the vaccine were eligible for 4 monthly booster vaccines at 12 months and 24
months.
DISEASE CHARACTERISTICS:
- Histologically confirmed mantle cell lymphoma
- Stage II, III, or IV disease
- Relapsed or de novo disease
- No symptomatic brain metastasis
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Eastern Cooperative Oncology Group (ECOG) 0-2
Life expectancy
- Not specified
Hematopoietic
- White blood count (WBC) > 3,000/mm^3
- Absolute neutrophil count > 1,500/mm^3
- Platelet count > 100,000/mm^3
- Hematocrit > 25%
- Hemoglobin > 8 g/dL
Hepatic
- Bilirubin < 2.0 mg/dL
Renal
- Creatinine < 2.0 mg/dL OR
- Creatinine clearance > 60 mL/min
Immunologic
- No serious ongoing infection
- No known HIV infection
- No other pre-existing immunodeficiency condition
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for 1 month before, during, and for
3 months after study treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No other concurrent immunotherapy
Chemotherapy
- More than 4 weeks since prior chemotherapy
- No other concurrent chemotherapy
Endocrine therapy
- More than 4 weeks since prior steroids
- No concurrent corticosteroids except as replacement doses in patients who are
hypoadrenal
Radiotherapy
- More than 2 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery
- Not specified
Other
- No other concurrent immunosuppressive therapy
We found this trial at
1
site
12902 USF Magnolia Dr
Tampa, Florida 33612
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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