Open-label, multi-center, non-randomized, single-arm study to evaluate the safety and efficacy of dendritic cell immunotherapy in patients with refractory solid malignancies, on supportive care

Bapsy, P. P.; Sharan, Bandana; Kumar, Chaitanya; Das, Rajeev Patrick; Rangarajan, Bharath; Jain, Minish; Attili, Venkata Sathya Suresh; Subramanian, Sundaram; Aggarwal, Sandeep; Srivastava, Mala; Vaid, Ashok

doi:10.1016/j.jcyt.2013.11.013

Cited by 35 publications

(27 citation statements)

References 30 publications

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“…The initial surge in PSA may be attributed to the heightened immune response, observed in various other studies. 32) The PSA values did not correlate with the response as SD and PR patients also showed surge in day 15 and day 60 values of PSA. All patients showed a positive DTH response against the TAA used for priming the DC.…”

Section: Discussionmentioning

confidence: 92%

“…Samples were analyzed on use of a flow cytometer (FACS Calibur, Becton Dickinson, U.S.A.). Ratio of CD4+ and CD8+ Cells Analysis of CD4 and CD8 lymphocyte count was performed according to the procedure earlier described by Bapsy et al 32) Briefly 2-3 mL of peripheral blood was incubated with the following antihuman monoclonal antibodies: anti-CD3-PC5, anti-CD4-FITC, anti-CD8-PE and anti-CD16-FITC (Becton Dickinson). After immunofluorescent staining, the cells were fixed with 1% paraformaldehyde and were then analyzed by means of a FACSCalibur flow cytometer with the use of CellQuest-PRO software (Becton Dickinson).…”

Section: Patient Population and Study Designmentioning

confidence: 99%

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Survivin and PSMA Loaded Dendritic Cell Vaccine for the Treatment of Prostate Cancer

Wang

et al. 2015

Biological & Pharmaceutical Bulletin

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Key words dendritic cell vaccine; prostate cancer; autologous cellular immunotherapy; prostate specific membrane antigen; Survivin Immunotherapy has recently emerged as a promising treatment modality for management of advanced hormone-refractory prostate cancer (HRPC), in light of new advances in discovery of cancer-specific antigens (tumor-associated antigen (TAA)), and adoptive cellular targeting. Dendritic cell (DC) based adoptive immunotherapy is one such treatment. Dendritic cells are the professional antigen presenting cells that efficiently activate T lymphocytes by presenting antigen to naïve major histocompatibility complex I restricted CD8+ cells and to major histocompatibility complex II restricted CD4+ cells. Dendritic cells generated from autologous monocytes (CD14+ cells) concentrated by aphaeresis, using a culture medium enriched with granulocyte macrophage colony-stimulating factor (GM-CSF), interleukin (IL)-4, or IL-13 1-4) and pulsed ex vivo with TAA have been found to elicit a potent T-cell-mediated immune response and also protect against further tumour challenges. [5][6][7][8] Results from various clinical studies indicate that DC-based therapy can lead to significant therapeutic benefit in cancer patients without any significant toxic side effects. [9][10][11][12] In 2010, the U.S. Food and Drugs Administration (FDA) approved Sipuleucel-T, an autologous dendritic cell vaccine for the treatment of HRPC, this has paved way for a new category of autologous cellular immunotherapy for management of prostate cancer.Prostate specific membrane antigen (PSMA) is a type II membrane protein with folate hydrolase activity expressed primarily in prostate epithelium and a limited number of other cell types. This well-defined prostate expression is significantly elevated in prostate cancer, especially in advanced stages, [12][13][14] furthermore, PSMA immunoreactivity is absent to moderate in most hyperplastic and benign tissues. These features make PSMA an excellent target for prostate cancer immunotherapy. Several PSMA-based vaccines have been developed and clinical trials indicate that these immunotherapy approaches can be safely administered and can induce immune responses in patients with advanced carcinoma of prostate. 15,16) Survivin is a member of the family of inhibitors of apoptosis which is involved in cell cycle progression and control of apoptosis.17) It is over-expressed in a number of human cancers [18][19][20][21] and is often associated with poor prognosis. [22][23][24] Because of its frequent over-expression in many cancer types, survivin constitutes an interesting tumour-associated antigen (TAA) target for T cell based immunotherapy. 21,25,26) Because of its nodal properties, and over-expression in virtually every human tumour, survivin has been intensely pursued as a drug target for novel cancer therapeutics. [27][28][29] Various studies suggest that a combination of TAA might be more efficient in dendritic cell based cancer immunotherapy than using a single TAA.These observations prom...

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Section: Discussionmentioning

confidence: 92%

Section: Patient Population and Study Designmentioning

confidence: 99%

Survivin and PSMA Loaded Dendritic Cell Vaccine for the Treatment of Prostate Cancer

Wang

et al. 2015

Biological & Pharmaceutical Bulletin

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“…[81] APCEDEN is a formulation of dendritic cells used in this study and is derived from CD14+ monocytes, which is further described in Romani et al [87] Bapsy et al concluded that the APCEDEN therapy leads to no major toxicity and is safe. Patients who were classified as responders had a median OS of 397 days and a significant improvement in quality of life, justifying the need for advanced development and randomized control trials.…”

Section: Uses In Pdac Therapy and Outcomesmentioning

confidence: 92%

“…The DCs can then be pulsed with the target ligand and activated using TNF-alpha. [79,[81][82][83][84] …”

Section: Production Of Dendritic Cellsmentioning

confidence: 99%

“…Patients who were classified as responders had a median OS of 397 days and a significant improvement in quality of life, justifying the need for advanced development and randomized control trials. [81] Another single arm study performed by Shindo et al tested DCs transfected with MUC1-mRNA and cytotoxic lymphocytes in addition to gemcitabine in 42 patients with unresectable pancreatic cancer. [88] MUC1 is Mucin 1, an antigen that is overexpressed in all cancer cell lineages of PDAC.…”

Section: Uses In Pdac Therapy and Outcomesmentioning

confidence: 99%

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Emerging therapies for pancreatic ductal carcinoma

Falcone

Davis

Stain

et al. 2016

JST

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Pancreatic ductal adenocarcinoma (PDAC) is a solid tumor mass that grows and metastasizes rapidly. There are no definitive methods for early detection and most patients are diagnosed at a late stage. Those diagnosed at an early stage are eligible for tumor resection. However, many of these patients are soon burdened with tumor recurrence. The tumor grows back aggressively and with resistance to the original chemotherapy. Gemcitabine has been the treatment of choice, but provides only minimal survival prolongation. Researchers are trying to improve the current standard of care by finding different methods to improve treatment efficacy and reduce side effects. This review emphasizes recent data on targeting the tumor using antifibrotic, nanotargeted, and dendritic cell therapies. Antifibrotic therapy aims to reduce tumor fibrosis, which prevents adequate chemotherapy penetration. Nanotargeted therapy offers precise targeting of cancer cells and chemotherapy delivery. Dendritic cell vaccines stimulate the body's immune system to target PDAC cells. These three treatment methods or a combination of them might improve the lifespan and quality of life for PDAC patients.

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Antigen-specific active immunotherapy for ovarian cancer

Paijens

Leffers

Daemen

et al. 2018

Cochrane Database of Systematic Reviews

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Open-label, multi-center, non-randomized, single-arm study to evaluate the safety and efficacy of dendritic cell immunotherapy in patients with refractory solid malignancies, on supportive care

Abstract: Therapy was safe. The responses, time to treatment progression and survival are encouraging for patients with aggressive refractory disease.

Cited by 35 publications

References 30 publications

Survivin and PSMA Loaded Dendritic Cell Vaccine for the Treatment of Prostate Cancer

Survivin and PSMA Loaded Dendritic Cell Vaccine for the Treatment of Prostate Cancer

Emerging therapies for pancreatic ductal carcinoma

Antigen-specific active immunotherapy for ovarian cancer

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