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Dendritic Cells (White Blood Cells) Vaccination for Advanced Melanoma

Primary Purpose

Melanoma

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

cyclophosphamide

Mature dendritic cell vaccine

About this trial

This is an interventional treatment trial for Melanoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Unresectable stage III and stage IV M1a/M1b/M1c melanoma including patients with uveal melanoma
Age ≥ 18 years
Life expectancy ≥ 4 months
ECOG performance status 0-2
At least 28 days from prior treatment (including adjuvant interferon) except in cases of a BRAF inhibitor (such as vemurafenib); concurrent treatment with a BRAF inhibitor +/- MEK inhibitor is permitted
Required initial laboratory values (submitted within 14 days prior to registration):
- WBC >3,000/mm3
- Hg ≥ 9.0 gm/dl
- Platelets >75,000/mm3
- Serum Bilirubin < 2.0 mg/dl
- Serum Creatinine < 2.0 mg/dl
Sexually active women of childbearing potential must use effective birth control during the trial and for at least two months following the trial, and sexually active men must be willing to avoid fathering a new child while receiving therapy.

Exclusion Criteria:

Prior treatment with more than one line of cytotoxic chemotherapy; prior treatment with one line of cytotoxic chemotherapy is permitted. Prior treatment with targeted therapy (such as ipilumumab, anti-PD1, and BRAF inhibitor) is permitted.
Active untreated CNS metastasis
Active infection
Prior malignancy (except non-melanoma skin cancer) within 3 years
Pregnant or nursing
Concurrent treatment with corticosteroids; local (inhaled or topical) steroids are permitted.
Inability to provide adequate informed consent
Known allergy to eggs
Prior history or uveitis or autoimmune inflammatory eye disease.
Known positivity for hepatitis BsAg, hepatitis C antibody, or HIV antibody.

Sites / Locations

Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Dendritic Cell Vaccine (First Group)

Dendritic Cell Vaccine (Second Group)

Dendritic Cell Vaccine (Third Group)

Arm Description

Blood mononuclear cells will be collected for vaccine production through apheresis. Patients will be given cyclophosphamide 300mg/m2 IV 3 days prior to vaccine dose #1 in order to deplete regulatory T cells. Patients will receive mature DC for each dose of vaccine and will receive autologous dendritic cells. The DC vaccine will be given intravenously every 3 weeks for a total of 6 doses. Peripheral blood will be taken weekly to monitor the immune response. Apheresis is repeated after vaccine dose #3 and dose #6 in order to collect PBMC for immune monitoring. Patients with stable disease or better after 6 doses will be eligible to receive additional vaccinations as maintenance therapy every 2 months until progression.

Blood mononuclear cells will be collected for vaccine production through apheresis. Patients will be given cyclophosphamide 300mg/m2 IV 3 days prior to vaccine dose #1 in order to deplete regulatory T cells. Patients will receive mature DC for each dose of vaccine and will receive autologous dendritic cells. The DC vaccine will be given intravenously every 6 weeks for a total of 3 doses. Peripheral blood will be taken weekly to monitor the immune response. Apheresis is repeated after vaccine dose #3 in order to collect PBMC for immune monitoring.

Outcomes

Primary Outcome Measures

Immunological response based on measuring increased numbers of peptide specific CD8+ T cells as calculated by the tetramer assay.

Starting on Day 0, two tubes will be drawn weekly until Day 64. Thereafter, two tubes will be drawn every 21 days until Day 190. For patients receiving maintenance treatment, blood is drawn every month. Data are presented as the percentage of CD8+ T cells positive for tetramer binding based on gating variables set using the iMASC reagent kit (Beckman Coulter).

Safety and tolerability of the mature dendritic cell vaccine as measured by adverse events

The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.

Secondary Outcome Measures

Time to progression

Regulatory T cell depletion after cyclophosphamide administration.

Regulatory T cells (Treg) are defined as CD4+CD25+foxP3+ (triple positive) cells. At the indicated time points, the percentage of Treg cells is determined by 3 color flow cytometry. The depletion of Treg is defined as follows [Treg baseline - Treg nadir/ Treg baseline x 100= % depletion].

Safety and side effect profile of mDC administered to patients given after a single dose of cyclophosphamide.

Clinical response rate using RECIST criteria

Full Information

NCT ID

NCT00683670

First Posted

May 19, 2008

Last Updated

February 21, 2017

Sponsor

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT00683670

Brief Title

Dendritic Cells (White Blood Cells) Vaccination for Advanced Melanoma

Official Title

Mature Dendritic Cell Vaccination Against gp100 in Patients With Advanced Melanoma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

August 2008 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells.

Detailed Description

Eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production. All patients will be given cyclophosphamide 300mg/m2 IV three days prior to vaccine dose #1 in order to deplete regulatory T cells. All patients will receive mature DC for each dose of vaccine. For each dose all patients will receive autologous dendritic cells pulsed with 2 gp100 melanoma peptides (G209-2M and G280-9V) plus up to an additional 10 unique melanoma tumor-specific peptides. All patients will receive booster doses with mature DC. The DC vaccine will be given intravenously every three weeks for a total of six vaccine doses. Peripheral blood (16 ml) will be taken weekly to monitor the immune response to each peptide by tetramer assay. Apheresis is repeated after vaccine dose #3 and dose #6 in order to collect PBMC for immune monitoring. Restaging is performed after three and six vaccine doses. Patients with stable disease or better (partial response/complete response) after six doses will be eligible to receive additional vaccinations as maintenance therapy every 2 months until progression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Melanoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dendritic Cell Vaccine (First Group)

Arm Type

Experimental

Arm Description

Arm Title

Dendritic Cell Vaccine (Second Group)

Arm Type

Experimental

Arm Description

Arm Title

Dendritic Cell Vaccine (Third Group)

Arm Type

Experimental

Arm Description

Blood mononuclear cells will be collected for vaccine production through apheresis. Patients will be given cyclophosphamide 300mg/m2 IV 3 days prior to vaccine dose #1 in order to deplete regulatory T cells. Patients will receive mature DC for each dose of vaccine and will receive autologous dendritic cells. The DC vaccine will be given intravenously every 6 weeks for a total of 3 doses. Peripheral blood will be taken weekly to monitor the immune response. Apheresis is repeated after vaccine dose #3 in order to collect PBMC for immune monitoring.

Intervention Type

Drug

Intervention Name(s)

cyclophosphamide

Other Intervention Name(s)

Cytoxan

Intervention Type

Biological

Intervention Name(s)

Mature dendritic cell vaccine

Primary Outcome Measure Information:

Title

Immunological response based on measuring increased numbers of peptide specific CD8+ T cells as calculated by the tetramer assay.

Description

Time Frame

Through completion of treatment

Title

Safety and tolerability of the mature dendritic cell vaccine as measured by adverse events

Description

The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.

Time Frame

30 days after end of treatment

Secondary Outcome Measure Information:

Title

Time to progression

Time Frame

Through completion of treatment or until progressive disease

Title

Regulatory T cell depletion after cyclophosphamide administration.

Description

Time Frame

Day -3 (72 hours prior to vaccine dose 1)

Title

Safety and side effect profile of mDC administered to patients given after a single dose of cyclophosphamide.

Time Frame

Day 0 (prior to vaccine dose 1)

Title

Clinical response rate using RECIST criteria

Time Frame

After third vaccine, sixth vaccine, and then every 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Unresectable stage III and stage IV M1a/M1b/M1c melanoma including patients with uveal melanoma Age ≥ 18 years Life expectancy ≥ 4 months ECOG performance status 0-2 At least 28 days from prior treatment (including adjuvant interferon) except in cases of a BRAF inhibitor (such as vemurafenib); concurrent treatment with a BRAF inhibitor +/- MEK inhibitor is permitted Required initial laboratory values (submitted within 14 days prior to registration): WBC >3,000/mm3 Hg ≥ 9.0 gm/dl Platelets >75,000/mm3 Serum Bilirubin < 2.0 mg/dl Serum Creatinine < 2.0 mg/dl Sexually active women of childbearing potential must use effective birth control during the trial and for at least two months following the trial, and sexually active men must be willing to avoid fathering a new child while receiving therapy. Exclusion Criteria: Prior treatment with more than one line of cytotoxic chemotherapy; prior treatment with one line of cytotoxic chemotherapy is permitted. Prior treatment with targeted therapy (such as ipilumumab, anti-PD1, and BRAF inhibitor) is permitted. Active untreated CNS metastasis Active infection Prior malignancy (except non-melanoma skin cancer) within 3 years Pregnant or nursing Concurrent treatment with corticosteroids; local (inhaled or topical) steroids are permitted. Inability to provide adequate informed consent Known allergy to eggs Prior history or uveitis or autoimmune inflammatory eye disease. Known positivity for hepatitis BsAg, hepatitis C antibody, or HIV antibody.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gerald P. Linette, M.D., Ph.D.

Organizational Affiliation

Abramson Cancer Center at Penn Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Washington University School of Medicine

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

12. IPD Sharing Statement

Citations:

Citation

Jemal, A., T. Murray, E. Ward, A. Samuels, R.C. Tiwari, A. Ghafoor, E.J. Feuer, and M.J. Thun. 2007. Cancer statistics, 2007. CA Cancer J Clin 57:42-59.

Results Reference

background

Citation

Lotze, M.T., R.M. Dallal, J.M. Kirkwood, and J.C. Flickinger. 2001. Cutaneous Melanoma. In Cancer:Principles and Practice of Oncology. V.T. DeVita, S. Hellman, and S.A. Rosenberg, editors. Lippincott, Williams, & Wilkins, Philadelphia. 2012-2069.

Results Reference

background

PubMed Identifier

15288283

Citation

Eggermont AM, Kirkwood JM. Re-evaluating the role of dacarbazine in metastatic melanoma: what have we learned in 30 years? Eur J Cancer. 2004 Aug;40(12):1825-36. doi: 10.1016/j.ejca.2004.04.030.

Results Reference

background

PubMed Identifier

16179860

Citation

Queirolo P, Acquati M, Kirkwood JM, Eggermont AM, Rocca A, Testori A. Update: current management issues in malignant melanoma. Melanoma Res. 2005 Oct;15(5):319-24. doi: 10.1097/00008390-200510000-00001.

Results Reference

background

PubMed Identifier

10840932

Citation

Serrone L, Zeuli M, Sega FM, Cognetti F. Dacarbazine-based chemotherapy for metastatic melanoma: thirty-year experience overview. J Exp Clin Cancer Res. 2000 Mar;19(1):21-34.

Results Reference

background

PubMed Identifier

11254118

Citation

Huncharek M, Caubet JF, McGarry R. Single-agent DTIC versus combination chemotherapy with or without immunotherapy in metastatic melanoma: a meta-analysis of 3273 patients from 20 randomized trials. Melanoma Res. 2001 Feb;11(1):75-81. doi: 10.1097/00008390-200102000-00009.

Results Reference

background

PubMed Identifier

10561349

Citation

Chapman PB, Einhorn LH, Meyers ML, Saxman S, Destro AN, Panageas KS, Begg CB, Agarwala SS, Schuchter LM, Ernstoff MS, Houghton AN, Kirkwood JM. Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J Clin Oncol. 1999 Sep;17(9):2745-51. doi: 10.1200/JCO.1999.17.9.2745.

Results Reference

background

Citation

Ernsdorf MS, C.T., and L Titus-Ernsdorf. 2003. Update: Medical therapy for cutaneous melanoma. ASCO Educational Book 39:198-207.

Results Reference

background

PubMed Identifier

10561265

Citation

Atkins MB, Lotze MT, Dutcher JP, Fisher RI, Weiss G, Margolin K, Abrams J, Sznol M, Parkinson D, Hawkins M, Paradise C, Kunkel L, Rosenberg SA. High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol. 1999 Jul;17(7):2105-16. doi: 10.1200/JCO.1999.17.7.2105.

Results Reference

background

PubMed Identifier

5272336

Citation

Morton DL, Eilber FR, Joseph WL, Wood WC, Trahan E, Ketcham AS. Immunological factors in human sarcomas and melanomas: a rational basis for immunotherapy. Ann Surg. 1970 Oct;172(4):740-9. doi: 10.1097/00000658-197010000-00018. No abstract available.

Results Reference

background

PubMed Identifier

4421563

Citation

Golub SH, Morton DL. Sensitisation of lymphocytes in vitro against human melanoma-associated antigens. Nature. 1974 Sep 13;251(5471):161-3. doi: 10.1038/251161a0. No abstract available.

Results Reference

background

PubMed Identifier

16409137

Citation

Waldmann TA. Effective cancer therapy through immunomodulation. Annu Rev Med. 2006;57:65-81. doi: 10.1146/annurev.med.56.082103.104549.

Results Reference

background

PubMed Identifier

7706734

Citation

Kawakami Y, Eliyahu S, Jennings C, Sakaguchi K, Kang X, Southwood S, Robbins PF, Sette A, Appella E, Rosenberg SA. Recognition of multiple epitopes in the human melanoma antigen gp100 by tumor-infiltrating T lymphocytes associated with in vivo tumor regression. J Immunol. 1995 Apr 15;154(8):3961-8.

Results Reference

background

PubMed Identifier

9672845

Citation

Kawakami Y, Robbins PF, Wang RF, Parkhurst M, Kang X, Rosenberg SA. The use of melanosomal proteins in the immunotherapy of melanoma. J Immunother. 1998 Jul;21(4):237-46. doi: 10.1097/00002371-199807000-00001.

Results Reference

background

PubMed Identifier

1840703

Citation

van der Bruggen P, Traversari C, Chomez P, Lurquin C, De Plaen E, Van den Eynde B, Knuth A, Boon T. A gene encoding an antigen recognized by cytolytic T lymphocytes on a human melanoma. Science. 1991 Dec 13;254(5038):1643-7. doi: 10.1126/science.1840703.

Results Reference

background

PubMed Identifier

8811494

Citation

Marincola FM, Hijazi YM, Fetsch P, Salgaller ML, Rivoltini L, Cormier J, Simonis TB, Duray PH, Herlyn M, Kawakami Y, Rosenberg SA. Analysis of expression of the melanoma-associated antigens MART-1 and gp100 in metastatic melanoma cell lines and in in situ lesions. J Immunother Emphasis Tumor Immunol. 1996 May;19(3):192-205. doi: 10.1097/00002371-199605000-00004.

Results Reference

background

PubMed Identifier

15522656

Citation

Mocellin S, Mandruzzato S, Bronte V, Lise M, Nitti D. Part I: Vaccines for solid tumours. Lancet Oncol. 2004 Nov;5(11):681-9. doi: 10.1016/S1470-2045(04)01610-9. Erratum In: Lancet Oncol. 2005 Jan;6(1):4.

Results Reference

background

PubMed Identifier

17272984

Citation

Parmiani G, Castelli C, Santinami M, Rivoltini L. Melanoma immunology: past, present and future. Curr Opin Oncol. 2007 Mar;19(2):121-7. doi: 10.1097/CCO.0b013e32801497d7.

Results Reference

background

PubMed Identifier

8113668

Citation

Bakker AB, Schreurs MW, de Boer AJ, Kawakami Y, Rosenberg SA, Adema GJ, Figdor CG. Melanocyte lineage-specific antigen gp100 is recognized by melanoma-derived tumor-infiltrating lymphocytes. J Exp Med. 1994 Mar 1;179(3):1005-9. doi: 10.1084/jem.179.3.1005.

Results Reference

background

PubMed Identifier

7513441

Citation

Cox AL, Skipper J, Chen Y, Henderson RA, Darrow TL, Shabanowitz J, Engelhard VH, Hunt DF, Slingluff CL Jr. Identification of a peptide recognized by five melanoma-specific human cytotoxic T cell lines. Science. 1994 Apr 29;264(5159):716-9. doi: 10.1126/science.7513441.

Results Reference

background

PubMed Identifier

10417764

Citation

Skipper JC, Gulden PH, Hendrickson RC, Harthun N, Caldwell JA, Shabanowitz J, Engelhard VH, Hunt DF, Slingluff CL Jr. Mass-spectrometric evaluation of HLA-A*0201-associated peptides identifies dominant naturally processed forms of CTL epitopes from MART-1 and gp100. Int J Cancer. 1999 Aug 27;82(5):669-77. doi: 10.1002/(sici)1097-0215(19990827)82:53.0.co;2-#.

Results Reference

background

PubMed Identifier

8840994

Citation

Salgaller ML, Marincola FM, Cormier JN, Rosenberg SA. Immunization against epitopes in the human melanoma antigen gp100 following patient immunization with synthetic peptides. Cancer Res. 1996 Oct 15;56(20):4749-57.

Results Reference

background

PubMed Identifier

9500606

Citation

Rosenberg SA, Yang JC, Schwartzentruber DJ, Hwu P, Marincola FM, Topalian SL, Restifo NP, Dudley ME, Schwarz SL, Spiess PJ, Wunderlich JR, Parkhurst MR, Kawakami Y, Seipp CA, Einhorn JH, White DE. Immunologic and therapeutic evaluation of a synthetic peptide vaccine for the treatment of patients with metastatic melanoma. Nat Med. 1998 Mar;4(3):321-7. doi: 10.1038/nm0398-321.

Results Reference

background

PubMed Identifier

16278389

Citation

Linette GP, Zhang D, Hodi FS, Jonasch EP, Longerich S, Stowell CP, Webb IJ, Daley H, Soiffer RJ, Cheung AM, Eapen SG, Fee SV, Rubin KM, Sober AJ, Haluska FG. Immunization using autologous dendritic cells pulsed with the melanoma-associated antigen gp100-derived G280-9V peptide elicits CD8+ immunity. Clin Cancer Res. 2005 Nov 1;11(21):7692-9. doi: 10.1158/1078-0432.CCR-05-1198.

Results Reference

background

PubMed Identifier

9973498

Citation

Yee C, Savage PA, Lee PP, Davis MM, Greenberg PD. Isolation of high avidity melanoma-reactive CTL from heterogeneous populations using peptide-MHC tetramers. J Immunol. 1999 Feb 15;162(4):2227-34.

Results Reference

background

PubMed Identifier

8943411

Citation

Skipper JC, Kittlesen DJ, Hendrickson RC, Deacon DD, Harthun NL, Wagner SN, Hunt DF, Engelhard VH, Slingluff CL Jr. Shared epitopes for HLA-A3-restricted melanoma-reactive human CTL include a naturally processed epitope from Pmel-17/gp100. J Immunol. 1996 Dec 1;157(11):5027-33.

Results Reference

background

PubMed Identifier

11509172

Citation

Mellman I, Steinman RM. Dendritic cells: specialized and regulated antigen processing machines. Cell. 2001 Aug 10;106(3):255-8. doi: 10.1016/s0092-8674(01)00449-4. No abstract available.

Results Reference

background

PubMed Identifier

11509176

Citation

Banchereau J, Schuler-Thurner B, Palucka AK, Schuler G. Dendritic cells as vectors for therapy. Cell. 2001 Aug 10;106(3):271-4. doi: 10.1016/s0092-8674(01)00448-2. No abstract available.

Results Reference

background

PubMed Identifier

9500607

Citation

Nestle FO, Alijagic S, Gilliet M, Sun Y, Grabbe S, Dummer R, Burg G, Schadendorf D. Vaccination of melanoma patients with peptide- or tumor lysate-pulsed dendritic cells. Nat Med. 1998 Mar;4(3):328-32. doi: 10.1038/nm0398-328.

Results Reference

background

PubMed Identifier

10587357

Citation

Thurner B, Haendle I, Roder C, Dieckmann D, Keikavoussi P, Jonuleit H, Bender A, Maczek C, Schreiner D, von den Driesch P, Brocker EB, Steinman RM, Enk A, Kampgen E, Schuler G. Vaccination with mage-3A1 peptide-pulsed mature, monocyte-derived dendritic cells expands specific cytotoxic T cells and induces regression of some metastases in advanced stage IV melanoma. J Exp Med. 1999 Dec 6;190(11):1669-78. doi: 10.1084/jem.190.11.1669.

Results Reference

background

PubMed Identifier

11522640

Citation

Banchereau J, Palucka AK, Dhodapkar M, Burkeholder S, Taquet N, Rolland A, Taquet S, Coquery S, Wittkowski KM, Bhardwaj N, Pineiro L, Steinman R, Fay J. Immune and clinical responses in patients with metastatic melanoma to CD34(+) progenitor-derived dendritic cell vaccine. Cancer Res. 2001 Sep 1;61(17):6451-8.

Results Reference

background

PubMed Identifier

15122249

Citation

Figdor CG, de Vries IJ, Lesterhuis WJ, Melief CJ. Dendritic cell immunotherapy: mapping the way. Nat Med. 2004 May;10(5):475-80. doi: 10.1038/nm1039.

Results Reference

background

PubMed Identifier

15203991

Citation

Ingram SB, O'Rourke MG. DC therapy for metastatic melanoma. Cytotherapy. 2004;6(2):148-53. doi: 10.1080/14653240410005627. No abstract available.

Results Reference

background

PubMed Identifier

16409156

Citation

Randolph DA, Fathman CG. Cd4+Cd25+ regulatory T cells and their therapeutic potential. Annu Rev Med. 2006;57:381-402. doi: 10.1146/annurev.med.57.121304.131337.

Results Reference

background

PubMed Identifier

15902688

Citation

Roncador G, Brown PJ, Maestre L, Hue S, Martinez-Torrecuadrada JL, Ling KL, Pratap S, Toms C, Fox BC, Cerundolo V, Powrie F, Banham AH. Analysis of FOXP3 protein expression in human CD4+CD25+ regulatory T cells at the single-cell level. Eur J Immunol. 2005 Jun;35(6):1681-91. doi: 10.1002/eji.200526189.

Results Reference

background

PubMed Identifier

15725955

Citation

Antony PA, Restifo NP. CD4+CD25+ T regulatory cells, immunotherapy of cancer, and interleukin-2. J Immunother. 2005 Mar-Apr;28(2):120-8. doi: 10.1097/01.cji.0000155049.26787.45.

Results Reference

background

PubMed Identifier

15591121

Citation

Lutsiak ME, Semnani RT, De Pascalis R, Kashmiri SV, Schlom J, Sabzevari H. Inhibition of CD4(+)25+ T regulatory cell function implicated in enhanced immune response by low-dose cyclophosphamide. Blood. 2005 Apr 1;105(7):2862-8. doi: 10.1182/blood-2004-06-2410. Epub 2004 Dec 9.

Results Reference

background

PubMed Identifier

16186187

Citation

Ko K, Yamazaki S, Nakamura K, Nishioka T, Hirota K, Yamaguchi T, Shimizu J, Nomura T, Chiba T, Sakaguchi S. Treatment of advanced tumors with agonistic anti-GITR mAb and its effects on tumor-infiltrating Foxp3+CD25+CD4+ regulatory T cells. J Exp Med. 2005 Oct 3;202(7):885-91. doi: 10.1084/jem.20050940. Epub 2005 Sep 26. Erratum In: J Exp Med. 2012 Feb 13;209(2):423.

Results Reference

background

PubMed Identifier

15981485

Citation

Nomura T, Sakaguchi S. Naturally arising CD25+CD4+ regulatory T cells in tumor immunity. Curr Top Microbiol Immunol. 2005;293:287-302. doi: 10.1007/3-540-27702-1_13.

Results Reference

background

PubMed Identifier

16036375

Citation

Sakaguchi S, Sakaguchi N. Regulatory T cells in immunologic self-tolerance and autoimmune disease. Int Rev Immunol. 2005 May-Aug;24(3-4):211-26. doi: 10.1080/08830180590934976.

Results Reference

background

PubMed Identifier

9755873

Citation

Bass KK, Mastrangelo MJ. Immunopotentiation with low-dose cyclophosphamide in the active specific immunotherapy of cancer. Cancer Immunol Immunother. 1998 Sep;47(1):1-12. doi: 10.1007/s002620050498.

Results Reference

background

PubMed Identifier

2143687

Citation

Hoon DS, Foshag LJ, Nizze AS, Bohman R, Morton DL. Suppressor cell activity in a randomized trial of patients receiving active specific immunotherapy with melanoma cell vaccine and low dosages of cyclophosphamide. Cancer Res. 1990 Sep 1;50(17):5358-64.

Results Reference

background

PubMed Identifier

8883420

Citation

Miles DW, Towlson KE, Graham R, Reddish M, Longenecker BM, Taylor-Papadimitriou J, Rubens RD. A randomised phase II study of sialyl-Tn and DETOX-B adjuvant with or without cyclophosphamide pretreatment for the active specific immunotherapy of breast cancer. Br J Cancer. 1996 Oct;74(8):1292-6. doi: 10.1038/bjc.1996.532.

Results Reference

background

PubMed Identifier

12070296

Citation

Steinman RM, Pope M. Exploiting dendritic cells to improve vaccine efficacy. J Clin Invest. 2002 Jun;109(12):1519-26. doi: 10.1172/JCI15962. No abstract available.

Results Reference

background

PubMed Identifier

15375003

Citation

Belardelli F, Ferrantini M, Parmiani G, Schlom J, Garaci E. International meeting on cancer vaccines: how can we enhance efficacy of therapeutic vaccines? Cancer Res. 2004 Sep 15;64(18):6827-30. doi: 10.1158/0008-5472.CAN-04-2048.

Results Reference

background

PubMed Identifier

16962496

Citation

Lin AM, Hershberg RM, Small EJ. Immunotherapy for prostate cancer using prostatic acid phosphatase loaded antigen presenting cells. Urol Oncol. 2006 Sep-Oct;24(5):434-41. doi: 10.1016/j.urolonc.2005.08.010.

Results Reference

background

PubMed Identifier

11452116

Citation

Pulendran B, Palucka K, Banchereau J. Sensing pathogens and tuning immune responses. Science. 2001 Jul 13;293(5528):253-6. doi: 10.1126/science.1062060.

Results Reference

background

PubMed Identifier

15172445

Citation

Moss P, Khan N. CD8(+) T-cell immunity to cytomegalovirus. Hum Immunol. 2004 May;65(5):456-64. doi: 10.1016/j.humimm.2004.02.014.

Results Reference

background

PubMed Identifier

12074049

Citation

Keilholz U, Weber J, Finke JH, Gabrilovich DI, Kast WM, Disis ML, Kirkwood JM, Scheibenbogen C, Schlom J, Maino VC, Lyerly HK, Lee PP, Storkus W, Marincola F, Worobec A, Atkins MB. Immunologic monitoring of cancer vaccine therapy: results of a workshop sponsored by the Society for Biological Therapy. J Immunother. 2002 Mar-Apr;25(2):97-138. doi: 10.1097/00002371-200203000-00001.

Results Reference

background

PubMed Identifier

17020987

Citation

Grover A, Kim GJ, Lizee G, Tschoi M, Wang G, Wunderlich JR, Rosenberg SA, Hwang ST, Hwu P. Intralymphatic dendritic cell vaccination induces tumor antigen-specific, skin-homing T lymphocytes. Clin Cancer Res. 2006 Oct 1;12(19):5801-8. doi: 10.1158/1078-0432.CCR-05-2421.

Results Reference

background

PubMed Identifier

15725923

Citation

Torabian S, Kashani-Sabet M. Biomarkers for melanoma. Curr Opin Oncol. 2005 Mar;17(2):167-71. doi: 10.1097/01.cco.0000154039.07466.5d.

Results Reference

background

PubMed Identifier

25837513

Citation

Carreno BM, Magrini V, Becker-Hapak M, Kaabinejadian S, Hundal J, Petti AA, Ly A, Lie WR, Hildebrand WH, Mardis ER, Linette GP. Cancer immunotherapy. A dendritic cell vaccine increases the breadth and diversity of melanoma neoantigen-specific T cells. Science. 2015 May 15;348(6236):803-8. doi: 10.1126/science.aaa3828. Epub 2015 Apr 2.

Results Reference

derived

PubMed Identifier

23867552

Citation

Carreno BM, Becker-Hapak M, Huang A, Chan M, Alyasiry A, Lie WR, Aft RL, Cornelius LA, Trinkaus KM, Linette GP. IL-12p70-producing patient DC vaccine elicits Tc1-polarized immunity. J Clin Invest. 2013 Aug;123(8):3383-94. doi: 10.1172/JCI68395. Epub 2013 Jul 11.

Results Reference

derived

Links:

URL

http://www.siteman.wustl.edu

Description

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

Dendritic Cells (White Blood Cells) Vaccination for Advanced Melanoma

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