Phase 2
N=43
Universal Granulocyte Macrophage-colony Stimulating Factor (GM-CSF)-Producing and GM.CD40L for Autologous Tumor Vaccine in Mantle Cell Lymphoma
Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00101101 ↗Enrolled (actual)
43
Serious AEs
4.7%
Results posted
Sep 2013
Primary outcome: Primary: Rate of Immunological Response to Vaccination — 0; 15 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cyclophosphamide (Drug); Doxorubicin (Drug); Vincristine (Drug); Prednisone (Drug); Dexamethasone (Drug); Autologous Tumor Cell-Based Vaccine (Biological); IL-2 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Primary completion
- Oct 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Immunological Response to Vaccination |
0; 15 | — |
| SECONDARY Occurrence of Related Serious Adverse Events (SAEs) |
— | — |
| SECONDARY Median Event Free Survival (EFS) |
9 | — |
Summary
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.
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT00101101). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.