PMID- 20539208
OWN - NLM
STAT- MEDLINE
DCOM- 20110602
LR  - 20210103
IS  - 1537-453X (Electronic)
IS  - 0277-3732 (Linking)
VI  - 34
IP  - 2
DP  - 2011 Apr
TI  - A phase 1 safety study of an IRX-2 regimen in patients with squamous cell 
      carcinoma of the head and neck.
PG  - 173-8
LID - 10.1097/COC.0b013e3181dbb9d8 [doi]
AB  - OBJECTIVES: Head and neck squamous cell carcinoma (HNSCC) is associated with 
      profound defects in cellular immunity. IRX-2, a primary cell-derived biologic 
      containing multiple cytokines, has enhanced immune responses and induced tumor 
      rejection in preclinical studies. This phase 1 open label study aimed to 
      determine the clinical and laboratory safety of an IRX-2 regimen in patients with 
      HNSCC. METHODS: Patients with HNSCC who had failed surgery and/or radiation 
      therapy were enrolled. IRX-2 was injected subcutaneously at 115 units per dose, 2 
      doses/d over 10 days, starting on day 4. Patients received low-dose 
      cyclophosphamide infusion on day 1 and took oral indomethacin and zinc daily from 
      day 1 through day 21. Safety and laboratory assessments were undertaken 
      throughout the treatment and 4 weeks after completion of the regimen. RESULTS: A 
      total of 13 patients with advanced disease were enrolled in the 
      safety/intent-to-treat population; all experienced treatment-emergent adverse 
      events (AEs). The most frequent AEs were blood and lymphatic disorders, followed 
      by gastrointestinal disorders. Most AEs were mild to moderate in severity. Three 
      patients discontinued the study due to an AE, including 2 deaths. Two patients 
      died after the study period due to tumor progression. No death or discontinuation 
      was considered related to the study drugs. Antitumor responses were noted by 
      radiographic assessment. In the 8 patients who had antitumor data at day 21, 1 
      patient had complete response, 5 had stable disease, and 2 had progressive 
      disease. CONCLUSIONS: The IRX-2 regimen was tolerated in patients with advanced 
      HNSCC who failed surgery and/or radiation therapy. The safety and antitumor 
      activity observed warrants further studies.
FAU - Freeman, Scott M
AU  - Freeman SM
AD  - IRX Therapeutics, Inc, New York, NY 10010, USA. info@irxtherapeutics.com
FAU - Franco, Jose Luis Barrera
AU  - Franco JL
FAU - Kenady, Daniel E
AU  - Kenady DE
FAU - Baltzer, Lorraine
AU  - Baltzer L
FAU - Roth, Zygmund
AU  - Roth Z
FAU - Brandwein, Harvey J
AU  - Brandwein HJ
FAU - Hadden, John W
AU  - Hadden JW
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Am J Clin Oncol
JT  - American journal of clinical oncology
JID - 8207754
RN  - 0 (Cytokines)
RN  - 0 (Gluconates)
RN  - 0 (IRX 2)
RN  - 8N3DW7272P (Cyclophosphamide)
RN  - R4R8J0Q44B (gluconic acid)
RN  - XXE1CET956 (Indomethacin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Carcinoma, Squamous Cell/drug therapy/*therapy
MH  - Cyclophosphamide/administration & dosage
MH  - Cytokines/adverse effects/*therapeutic use
MH  - Drug Administration Schedule
MH  - Female
MH  - Gluconates/administration & dosage
MH  - Head and Neck Neoplasms/drug therapy/*therapy
MH  - Humans
MH  - *Immunotherapy
MH  - Indomethacin/administration & dosage
MH  - Intention to Treat Analysis
MH  - Male
MH  - Middle Aged
MH  - Safety
EDAT- 2010/06/12 06:00
MHDA- 2011/06/03 06:00
CRDT- 2010/06/12 06:00
PHST- 2010/06/12 06:00 [entrez]
PHST- 2010/06/12 06:00 [pubmed]
PHST- 2011/06/03 06:00 [medline]
AID - 10.1097/COC.0b013e3181dbb9d8 [doi]
PST - ppublish
SO  - Am J Clin Oncol. 2011 Apr;34(2):173-8. doi: 10.1097/COC.0b013e3181dbb9d8.