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IND Protocols & Publications

IND #: 9817 (E75)

HER-2/neu Peptide (369-377, Multiple Peptide Systems) with Granulocyte-Macrophage Colony-Stimulating Factor (Immunex) Adjuvant

Trials:

  1. Phase Ib Trial of HER2/neu Peptide (E75) Vaccine in Patients at High Risk for Recurrence after Surgical Extirpation of Prostate Cancer (2000-2008) COMPLETED

    Publications:
    1. Hueman MT, Dehqanzada ZA, Novak TE, Gurney JM, Woll MM, Ryan GB, Storrer CE, Fisher C, McLeod DG, Moul JW, Ioannides CG, Ponniah S, Peoples GE. Phase I of a HER-2/neu peptide (E75) for the prevention of prostate-specific antigen recurrence in high-risk prostate cancer patients. Clin Cancer Res 2005;11:7470-9.
    2. Gates, JD, Carmichael MG, Benavides LC, Holmes JP, Hueman MT, Woll MM, Ioannides CG, Robson CH, McLeod DG, Ponniah S, Peoples GE. Long-term follow-up assessment of a HER2/neu peptide (E75) vaccine for the prevention of recurrence in high-risk prostate cancer patients. J Am Coll Surg 2009;208:193-201.

     

  2. Phase Ib Trial of HER2/neu Peptide (E75) Vaccine in Node Negative Breast Cancer Patients (2003-2013) COMPLETED
  3. Phase Ib Trial of HER2/neu Peptide (E75) Vaccine in Breast Cancer Patients at High Risk for Recurrence after Surgical and Medical Therapies (2000-2013) COMPLETED

    Publications:
    1. Peoples GE, Gurney JM, Hueman MT, Woll MM, Ryan GB, Storrer CE, Fisher C, Shriver CD, Ioannides CG, Ponniah S. Clinical trial results of a HER2/neu (E75) vaccine to prevent recurrence in high risk breast cancer patients. J Clin Oncol 2005;23:7536-45.
    2. Peoples GE, Holmes JP, Hueman MT, Mittendorf EA, Amin A, Khoo S, Dehqanzada ZA, Gurney JM, Woll MM, Ryan GB, Storrer CE, Craig D, Ioannides CG, Ponniah S. Combined clinical trial results of a HER2/neu (E75) vaccine for the prevention of recurrence in high-risk breast cancer patients: United States Military Cancer Institute Clinical Trials Group Study I-01&I-02. Clin Cancer Res 2008;14:797-803.
    3. Mittendorf EA, Clifton GT, Holmes JP, Clive KS, Patil R, Benavides LC, Gates JD, Sears AK, Stojadinovic A, Ponniah S, Peoples GE.  Clinical trial results of the HER-2/neu (E75) vaccine to prevent breast cancer recurrence in high-risk patients: From US Military Cancer Institute Clinical Trials Group Study I-01 and I-01.  Cancer2012;118:2594-602.
    4. Mittendorf EA, Clinton GT, Holmes JP, Schneble E, van Echo D, Ponniah S, Peoples GE. Final report of the phase I/II clinical trial of the E75 (nelipepimut-S) vaccine with booster inoculations to prevent disease recurrence in high-risk breast cancer patients. Ann Oncol 2014 Jun6 [Epub ahead of print].

 


IND # 11730 (GP2)

HER-2/neu Peptide (GP2, Multiple Peptide Systems) with Granulocyte Macrophage Colony-Stimulating Factor (Immunex) Adjuvant

Trials:

  1. Phase Ib Trial of HER2/neu Peptide (GP2) Vaccine in Breast Cancer Patients 2004-2014 COMPLETED

    Publications
    1. Carmichael MG, Benavides LC, Holmes JP, Gates JD, Mittendorf EA, Ponniah S, Peoples GE. Results of the first phase I clinical trial of the HER-2/neu peptide (GP2) vaccine in disease-free breast cancer patients: United States Military Cancer Institute Clinical Trials Group Study 1-04. Cancer 2010;116:292-301.

     

  2. Prospective, Randomized, Single-Blinded, Multi-Center Phase II Trial of the HER2/neu Peptide GP2 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2+ UORU the Modified HER2/neu Peptide AE37 + GM-CSF Vaccine versus GM-CSF alone in HLA-A2 Node-Positive and High-Risk Node-Negative Breast Cancer Patients to Prevent Recurrence (2007 to Present) ONGOING
  3. Phase Ib Trial of Combination Immunotherapy with HER2/neu Peptide GP2 + GM-CSF Vaccine and Trastuzumab in BreastCancer Patients 2008-2014 COMPLETED

 


IND # 12229 (AE37)

HER-2/neu Peptide (776-790 [AE37], NeoMPS) with Granulocyte-  Macrophage Colony-Stimulating Factor (Immunex) Adjuvant; Administered Intradermal

Trials:

  1. Phase Ib Trial of a HER2/neu Hybrid Peptide (AE37) Vaccine in Breast Cancer Patients (2005-2013) COMPLETED

    Publications:
    1. Holmes JP, Benavides LC, Gates JD, Carmichael MG, Hueman MT, Mittendorf EA, Murray JL, Amin A, Craig D, von Hofe E, Ponniah S, Peoples GE. Results of the first phase I clinical trial of the novel Ii-key hybrid preventive HER2/neu peptide (AE37) vaccine: United States Military Cancer Institute Clinical Trials Group Study I-03. J Clin Oncol 2008; 26: 3426-33.

     

  2. Prospective, Randomized, Single-Blinded, Multi-Center Phase II Trial of the HER2/neu Peptide GP2 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2+ UORU the Modified HER2/neu Peptide AE37 + GM-CSF Vaccine versus GM-CSF alone in HLA-A2 Node-Positive and High-Risk Node-Negative Breast Cancer Patients to Prevent Recurrence (2007-Present)

 

Publications:
  1. Mittendorf, EA, Ardavanis, A, Symanowski, J, Murray, JL, Shumway, NM, Litton, JK, Hale DF, Perez, SA, Anastasopoulou, EA, Pistamaltzian, NF, Ponniah, S, Baxevanis, CN, Von Hofe, E, Papamichail, M, Peoples GE. Primary Analysis of a Prospective, Randomized, Single-Blinded Phase II Trial Evaluating the HER2 Peptide AE37 Vaccine in Breast Cancer Patients to Prevent Recurrence. Ann Oncol 2016 March 30 [Epub ahead of print].

IND # 12391 (E39)

Folate Binding Protein Peptide (E39, NeoMPS) with Granulocyte-Macrophage Colony-Stimulating Factor (Immunex) Adjuvant;Administered Interdermal (2006 –Present)

Trials:

  1. Phase I/IIa Trial of Folate Binding Protein (FBP) Peptides (E39 and J65) Vaccines in Ovarian and Endometrial Cancer Patients (2013-Present) ONGOING

 


IND #: 15305 (J65 now referred to as E39’)

Folate Binding Protein (FBP) Attenuated Peptide J65 Vaccine (2013 – Present)

Trials:

  1. Phase Ib Trial of Folate Binding Protein (FBP) Peptide (E39) Vaccine in Ovarian and Endometrial Cancer Patients (2006- Present) ONGOING

 


IND # 13740 (AE37 + GP2)

HER-2/neu Peptide (GP2, NeoMPS) with Granulocyte-Macrophage Colony-Stimulating Factor and HER2/neu Peptide (AE37, NeoMPS) with Granulocyte-Macrophage Colony-Stimulating Factor

Trials:

  1. A Multi-Center Phase I Evaluation of the Doublet MCH Class I and II HER2/neu Peptide Vaccines (GP2 and AE37, respectively) in HLA-A2+ or HLA-A3+ Patients with Intermediate- to High-Risk Breast and/or Ovarian Cancer (2008 – 2014) COMPLETED

 


IND # 14919 (E75 + Herceptin)

Combination Immunotherapy with Herceptin and the HER2 Vaccine E75 in Low and Intermediate HER2-Expressing Breast Cancer Patients to Prevent Recurrence (2011 – Present)

Trials:

  1. Combination immunotherapy with Herceptin and the HER2 vaccine E75 in low and intermediate HER2-expressing breast cancer patients to prevent recurrence ONGOING
  2. Phase II Trial of Combination Immunotherapy with nelipepimut-S + GM-CSF (NeuVax) and Trastuzumab in high-risk HER2+ Breast Cancer Patients (2014-0443) ONGOING

 


IND # 16101 (TL + YCWP + DC)

Trials:

  1. A prospective, randomized, blinded, placebo-controlled, phase IIb trial of an autologous tumor lysate (TL) + yeast cell wall particles (YCWP) + dendritic cells (DC) vaccine vs. unloaded YCWP + DC in stage III and stage IV (resected) melanoma to prevent recurrence ONGOING
  2.  Multi-center phase I/IIa trial of an autologous tumor lysate (TL) + yeast cell wall particles (YCWP) + dendritic cells (DC) vaccine in addition to standard of care checkpoint inhibitor of choice in metastatic melanoma patients with stable or slowly progressing disease. ONGOING