PMID- 24335700
OWN - NLM
STAT- MEDLINE
DCOM- 20140918
LR  - 20230413
IS  - 1523-5866 (Electronic)
IS  - 1522-8517 (Print)
IS  - 1522-8517 (Linking)
VI  - 16
IP  - 2
DP  - 2014 Jan
TI  - Heat-shock protein peptide complex-96 vaccination for recurrent glioblastoma: a 
      phase II, single-arm trial.
PG  - 274-9
LID - 10.1093/neuonc/not203 [doi]
AB  - BACKGROUND: Outcomes for patients with recurrent glioblastoma multiforme (GBM) 
      are poor and may be improved by immunotherapy. We investigated the safety and 
      efficacy of an autologous heat-shock protein peptide complex-96 (HSPPC-96) 
      vaccine for patients with recurrent GBM. METHODS: In this open-label, single-arm, 
      phase II study, adult patients with surgically resectable recurrent GBM were 
      given vaccine after gross total resection. The primary endpoint was overall 
      survival at 6 months. Secondary endpoints included overall survival, 
      progression-free survival, safety, and immune profiling. Outcome analyses were 
      performed in the intention-to-treat and efficacy populations. RESULTS: Between 
      October 3, 2007 and October 24, 2011, 41 patients underwent gross total resection 
      of recurrent GBM and received a median of 6 doses of HSPPC-96 vaccine. Following 
      treatment, 90.2% of patients were alive at 6 months (95% confidence interval 
      [CI]: 75.9-96.8) and 29.3% were alive at 12 months (95% CI: 16.6-45.7). Median 
      overall survival was 42.6 weeks (95% CI: 34.7-50.5). Twenty-seven (66%) patients 
      were lymphopenic prior to therapy, and patients with lymphocyte counts below the 
      cohort median demonstrated decreased overall survival (hazard ratio: 4.0; 95% CI: 
      1.4-11.8; P = .012). There were no treatment-related deaths. There were 37 
      serious (grades 3-5) adverse events reported, with 17 attributable to surgical 
      resection and a single grade 3 constitutional event related to the vaccine. 
      CONCLUSION: The HSPPC-96 vaccine is safe and warrants further study of efficacy 
      for the treatment of recurrent GBM. Significant pretreatment lymphopenia may 
      impact the outcomes of immunotherapy and deserves additional investigation.
FAU - Bloch, Orin
AU  - Bloch O
AD  - Corresponding Author: Andrew T. Parsa, MD, PhD, Professor and Chair, Department 
      of Neurological Surgery, Northwestern University, Feinberg School of Medicine, 
      676 N. St. Clair Street, Suite 2210, Chicago, IL 60611. aparsa@nmff.org.
FAU - Crane, Courtney A
AU  - Crane CA
FAU - Fuks, Yelena
AU  - Fuks Y
FAU - Kaur, Rajwant
AU  - Kaur R
FAU - Aghi, Manish K
AU  - Aghi MK
FAU - Berger, Mitchel S
AU  - Berger MS
FAU - Butowski, Nicholas A
AU  - Butowski NA
FAU - Chang, Susan M
AU  - Chang SM
FAU - Clarke, Jennifer L
AU  - Clarke JL
FAU - McDermott, Michael W
AU  - McDermott MW
FAU - Prados, Michael D
AU  - Prados MD
FAU - Sloan, Andrew E
AU  - Sloan AE
FAU - Bruce, Jeffrey N
AU  - Bruce JN
FAU - Parsa, Andrew T
AU  - Parsa AT
LA  - eng
GR  - P50 CA097257/CA/NCI NIH HHS/United States
GR  - R01 CA164714/CA/NCI NIH HHS/United States
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
DEP - 20131212
PL  - England
TA  - Neuro Oncol
JT  - Neuro-oncology
JID - 100887420
RN  - 0 (Cancer Vaccines)
RN  - 0 (Heat-Shock Proteins)
RN  - 492448-75-6 (vitespin)
SB  - IM
CIN - Neuro Oncol. 2014 Jan;16(2):169-70. PMID: 24443362
CIN - Neuro Oncol. 2014 May;16(5):757. PMID: 24733854
MH  - Adult
MH  - Aged
MH  - Brain Neoplasms/*drug therapy/mortality/pathology
MH  - Cancer Vaccines/*therapeutic use
MH  - Female
MH  - Follow-Up Studies
MH  - Glioblastoma/*drug therapy/mortality/pathology
MH  - Heat-Shock Proteins/*therapeutic use
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Recurrence, Local/drug therapy/pathology
MH  - Neoplasm Staging
MH  - Prognosis
MH  - Survival Rate
MH  - Vaccination
PMC - PMC3895386
OTO - NOTNLM
OT  - glioblastoma
OT  - heat-shock proteins
OT  - immunotherapy
EDAT- 2013/12/18 06:00
MHDA- 2014/09/19 06:00
PMCR- 2015/01/01
CRDT- 2013/12/17 06:00
PHST- 2013/12/17 06:00 [entrez]
PHST- 2013/12/18 06:00 [pubmed]
PHST- 2014/09/19 06:00 [medline]
PHST- 2015/01/01 00:00 [pmc-release]
AID - not203 [pii]
AID - 10.1093/neuonc/not203 [doi]
PST - ppublish
SO  - Neuro Oncol. 2014 Jan;16(2):274-9. doi: 10.1093/neuonc/not203. Epub 2013 Dec 12.