Phase 2
N=11
Phase II Feasibility Study of Dendritic Cell Vaccination for Newly Diagnosed Glioblastoma Multiforme
Glioblastoma Multiforme
Bottom Line
View on ClinicalTrials.gov: NCT00323115 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcome: Primary: Tumor-specific Cytotoxic T-cell Response — 0.496; 0.4836 10^9 cells/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Autologous Dendritic Cell (Biological); Temozolomide (Drug); Radiotherapy (Procedure); Dendritic Cell Vaccine (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Apr 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor-specific Cytotoxic T-cell Response |
0.496; 0.4836 | — |
| SECONDARY Number of Adverse Events: Toxicity Profile of Intra-nodal DC/Tumor Lysate Vaccination |
1 | — |
| SECONDARY Number of Participants With Evaluable Data: Feasibility of Vaccination |
10 | — |
| SECONDARY Progression Free Survival (PFS) |
9.5 | — |
| SECONDARY Number of Participants With Significant Difference in Tumor Volume Size Pre- and Postvaccination: Neuroimaging and Tumor Assessment |
— | — |
| SECONDARY Overall Survival Duration: Efficacy Parameters |
28 | — |
| SECONDARY Frequency of CD4+ and CD8+ T Cells - the Proportion of Cells in the Parent Population Responding to Glioblastoma Multiforme (GBM) - Median |
0.003; 0.01; 0.001; 0.001 | — |
| SECONDARY Percentage of Tumor-specific T-cells - Correlation Between Immunological Parameters and Efficacy- Median |
0.15; 0.25; 0.27; 0.25 | — |
| SECONDARY Number of Enzyme-linked Immunosorbent Spots (ELISPOT) - Correlation Between Immunological Parameters and Efficacy - Median |
0; 0 | — |
| SECONDARY Frequency of CD4+ and CD8+ T Cells - the Proportion of Cells in the Parent Population Responding to Glioblastoma Multiforme (GBM) - Mean |
0.005; 0.01; 0.001; 0.003 | — |
| SECONDARY Percentage of Tumor-specific T-cells - Correlation Between Immunological Parameters and Efficacy- Mean |
0.38; 0.88; 0.45; 0.92 | — |
| SECONDARY Number of Enzyme-linked Immunosorbent Spots (ELISPOT) - Correlation Between Immunological Parameters and Efficacy - Mean |
1.40; 44.2 | — |
| SECONDARY Evaluation of T Cell Characteristics |
30.8; 25.8; 19.3; 34.6; 30.5; 23.7 | — |
| SECONDARY Immunohistochemistry |
— | — |
Summary
Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme will be treated with radiotherapy/chemotherapy followed by dendritic cell vaccine. Chemotherapy will be administered after three vaccinations for one year or until progression of disease.
Eligibility Criteria
Inclusion Criteria
- Histologically proven GBM with central pathology review at Dartmouth-Hitchcock Medical Center (DHMC)
- Tumor specimen obtained at the time of surgery adequate for vaccination
- 18 years of age or older
- Karnofsky Performance Status 60% or greater
- Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10 9th/L
- Platelets greater than or equal to 100 x 10 9th/L
- Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) less than or equal to 5 times the upper limits of normal (ULN)
- Total bilirubin less than or equal to 1.5 times ULN
- Serum creatinine less than or equal to 1.5 times ULN, OR estimated creatinine clearance greater than or equal to 60 mL/min
- No known immunosuppression other than chemo-related
- Negative HIV serologies
- No evidence of acute or chronic hepatitis on standard hepatitis C and B screening tests
- No chemotherapy within four weeks prior to leukapheresis
- Radiotherapy at outside institution is permitted if tissue was obtained at time of surgery at DHMC and patient is willing to follow-up per protocol
- Off steroids for at least two weeks before leukapheresis
- No second malignancies except non-melanoma skin cancer, and non-invasive cancer such at cervical CIS, superficial bladder cancer or breast CIS
- Negative serum or urine pregnancy test for women of childbearing potential
- No serious uncontrolled medical disorder or active infection
- All patients must give informed consent
- No history of clinical evidence of active autoimmune disease
Exclusion Criteria
- Invasive cancers in the past 5 years
- Rheumatologic/autoimmune disease
- Pregnancy or unwillingness to remain on acceptable form of birth control during study
- Major cardiac, pulmonary, or other systemic disease; viral hepatitis; HIV infection
Data sourced from ClinicalTrials.gov (NCT00323115). 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.