A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer - Study Results - ClinicalTrials.gov

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A Phase 2 Clinical Trial of the Safety and Effects of IRX-2 in Treating Patients With Operable Head and Neck Cancer

This study has been completed.

Study NCT00210470 Information provided by IRX Therapeutics

First Received on September 13, 2005. Last Updated on January 6, 2012 History of Changes

Results First Received: January 6, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Squamous Cell Carcinoma of the Head and Neck
Interventions:	Biological: IRX-2 Drug: Cyclophosphamide Drug: Indomethacin Drug: Zinc Drug: Omeprazole

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
IRX-2 Regimen	The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.

Participant Flow: Overall Study

	IRX-2 Regimen
STARTED	27
COMPLETED	26
NOT COMPLETED	1
Subject did not continue to surgery	1

Baseline Characteristics

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Reporting Groups

	Description
IRX-2 Regimen	The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.

Baseline Measures

	IRX-2 Regimen
Number of Participants [units: participants]	27
Age [units: participants]
<=18 years	0
Between 18 and 65 years	24
>=65 years	3
Age [units: years] Mean ± Standard Deviation	57.4 ± 9.4
Gender [units: participants]
Female	7
Male	20
Region of Enrollment [units: participants]
United States	26
Mexico	1

Outcome Measures

1. Primary:

Safety [ Time Frame: Enrollment through 30 days post-surgery ]

Show Outcome Measure 1

2. Secondary:

Clinical and Histological Tumor Responses [ Time Frame: At approx. 21 days, prior to surgery ]

Results not yet posted. Anticipated Posting Date: 09/2012 Safety Issue: No

3. Secondary:

Evaluate Patient Tolerance of Surgery and Post-operative Adjuvant Therapy; [ Time Frame: Following surgery and post-operative therapy ]

Results not yet posted. Anticipated Posting Date: 09/2012 Safety Issue: No

4. Secondary:

Immune Competence as Measured by Lymphocyte Infiltration [ Time Frame: At approx. 21 days, prior to surgery ]

Results not yet posted. Anticipated Posting Date: 09/2012 Safety Issue: No

5. Secondary:

Disease-free Survival [ Time Frame: Time from cyclophosphamide administration and time from surgery to death or confirmed recurrent or progressive disease ]

Results not yet posted. Anticipated Posting Date: 09/2012 Safety Issue: No

6. Secondary:

Overall Survival [ Time Frame: Time from cyclophosphamide administration and time from surgery to death or confirmed recurrent or progressive disease ]

Results not yet posted. Anticipated Posting Date: 09/2012 Safety Issue: No

7. Secondary:

Correlation of Tumor Response or Immune Competence (Lymphocyte Infiltration) With Disease-Free Survival or Overall Survival [ Time Frame: Time from cyclophosphamide administration and time from surgery to death or confirmed recurrent or progressive disease ]

Results not yet posted. Anticipated Posting Date: 09/2012 Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: At least 60 days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy of all such manuscripts and materials, and allow Sponsor 60 days to review and comment on them. If Sponsor requests, the Site shall remove any Confidential Information (other than Study results) prior to submitting or presenting the materials.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Zygmund Roth, Ph.D., V.P., Regulatory Affairs and QA
Organization: IRX Therapeutics, Inc.
phone: 631-465-2028
e-mail: zroth@irxtherapeutics.com

Publications of Results:

Freeman SM, Franco JL, Kenady DE, Baltzer L, Roth Z, Brandwein HJ, Hadden JW. A phase 1 safety study of an IRX-2 regimen in patients with squamous cell carcinoma of the head and neck. Am J Clin Oncol. 2011 Apr;34(2):173-8.

Wolf GT, Fee WE Jr, Dolan RW, Moyer JS, Kaplan MJ, Spring PM, Suen J, Kenady DE, Newman JG, Carroll WR, Gillespie MB, Freeman SM, Baltzer L, Kirkley TD, Brandwein HJ, Hadden JW. Novel neoadjuvant immunotherapy regimen safety and survival in head and neck squamous cell cancer. Head Neck. 2011 Dec;33(12):1666-74. Epub 2011 Jan 31.

Berinstein NL, Wolf GT, Naylor PH, Baltzer L, Egan JE, Brandwein HJ, Whiteside TL, Goldstein LC, El-Naggar A, Badoual C, Fridman WH, White JM, Hadden JW. Increased lymphocyte infiltration in patients with head and neck cancer treated with the IRX-2 immunotherapy regimen. Cancer Immunol Immunother. 2011 Nov 6; [Epub ahead of print]

Whiteside TL, Butterfield LH, Naylor PH, Egan JE, Hadden JW, Baltzer L, Wolf GT, Berinstein NL. A short course of neoadjuvant IRX-2 induces changes in peripheral blood lymphocyte subsets of patients with head and neck squamous cell carcinoma. Cancer Immunol Immunother. 2011 Nov 23; [Epub ahead of print]

Other Publications:

Schilling B, Harasymczuk M, Schuler P, Egan JE, Whiteside TL. IRX-2, a novel biologic, favors the expansion of T effector over T regulatory cells in a human tumor microenvironment model. J Mol Med (Berl). 2012 Feb;90(2):139-47. Epub 2011 Sep 14.

Czystowska M, Szczepanski MJ, Szajnik M, Quadrini K, Brandwein H, Hadden JW, Whiteside TL. Mechanisms of T-cell protection from death by IRX-2: a new immunotherapeutic. Cancer Immunol Immunother. 2011 Apr;60(4):495-506. Epub 2010 Dec 23.

Naylor PH, Hernandez KE, Nixon AE, Brandwein HJ, Haas GP, Wang CY, Hadden JW. IRX-2 increases the T cell-specific immune response to protein/peptide vaccines. Vaccine. 2010 Oct 8;28(43):7054-62. Epub 2010 Aug 13.

Naylor PH, Hadden JW. Preclinical studies with IRX-2 and thymosin alpha1 in combination therapy. Ann N Y Acad Sci. 2010 Apr;1194:162-8. Review.

Rapidis AD, Wolf GT. Immunotherapy of head and neck cancer: current and future considerations. J Oncol. 2009;2009:346345. Epub 2009 Aug 9.

Czystowska M, Han J, Szczepanski MJ, Szajnik M, Quadrini K, Brandwein H, Hadden JW, Signorelli K, Whiteside TL. IRX-2, a novel immunotherapeutic, protects human T cells from tumor-induced cell death. Cell Death Differ. 2009 May;16(5):708-18. Epub 2009 Jan 30.

Bright J, Al-Shamahi A. BioPartnering Europe--15th Annual Conference. Highlights from open house and emerging company presentations--Part 1. IDrugs. 2007 Dec;10(12):855-7. No abstract available.

Egan JE, Quadrini KJ, Santiago-Schwarz F, Hadden JW, Brandwein HJ, Signorelli KL. IRX-2, a novel in vivo immunotherapeutic, induces maturation and activation of human dendritic cells in vitro. J Immunother. 2007 Sep;30(6):624-33.

Hadden JW, Verastegui E, Hadden E. IRX-2 and thymosin alpha1 (Zadaxin) increase T lymphocytes in T lymphocytopenic mice and humans. Ann N Y Acad Sci. 2007 Sep;1112:245-55. Epub 2007 Jun 28.

Naylor PH, Quadrini K, Garaci E, Rasi G, Hadden JW. Immunopharmacology of thymosin alpha1 and cytokine synergy. Ann N Y Acad Sci. 2007 Sep;1112:235-44. Epub 2007 Jun 13.

Bayes M, Rabasseda X, Prous JR. Gateways to clinical trials. Methods Find Exp Clin Pharmacol. 2004 Sep;26(7):587-612. Review.

Hadden JW. Immunodeficiency and cancer: prospects for correction. Int Immunopharmacol. 2003 Aug;3(8):1061-71. Review.

Responsible Party:	IRX Therapeutics
ClinicalTrials.gov Identifier:	NCT00210470 History of Changes
Other Study ID Numbers:	IRX-2 2005-A
Study First Received:	September 13, 2005
Results First Received:	January 6, 2012
Last Updated:	January 6, 2012
Health Authority:	United States: Food and Drug Administration

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