Willard ("Bill") E. Fee, Jr.
A Phase 2 Clinical Trial of the Effectiveness of IRX-2 in Treating Patients With Operable Head and Neck Cancer
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
IRX-2 is designed to activate your own body's immune system so that it can better fight the invasion of head and neck cancer. Researchers hope that IRX-2 will help your immune system to mount a more effective attack on the cancer. IRX-2 has been tested in two clinical studies involving over 50 patients with head and neck cancer. The trials were specifically designed to test the safety of IRX-2. Researchers found that IRX-2 did not appear to have major side effects. In both trials, the researchers found evidence of tumor shrinkage. This may suggest that the immune system was attacking the cancer. Keep in mind that these are only considered to be preliminary results that provide scientists with enough evidence to continue studying IRX-2. They need to conduct more trials to prove that IRX-2 works and can be made publicly available.
Recruiting Status:
No longer recruitingStanford Recruiting Status:
No longer recruitingCondition(s):
Intervention(s):
- Drug: IRX-2
- Drug: Cyclophosphamide
- Drug: Indomethacin
- Drug: Zinc
- Drug: Omeprazole
Phase:
Phase 2Eligibility
Ages Eligible for Study:
18 years to 80 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
- Pathologically confirmed (histology) Squamous Cell Carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx.
- No prior surgery, radiation therapy or chemotherapy of this tumor other than biopsy or emergency procedure required for supportive care.
- Clinically staged Stage II, III, or IVA cancer, assessed to be surgically resectable with curative intent.
- Life Expectancy of greater than 6 months
Key Exclusion Criteria:
- Stage IVB Squamous Cell Carcinoma
- Use of any investigational agent within the previous 30 days
- Uncontrolled cardiovascular disease
- Myocardial infarction within the last 3 months
- Abnormal hemoglobin, neutrophil, lymphocyte or platelet counts
- Positive for hepatitis B or C or HIV
- Evidence of distant metastases
- Clinical gastritis or peptic ulcer within the last 6 months
- Stroke within the last six months
Additional Study Details
Official Title:
A Phase 2, Open-Label Trial of the Safety and Biological Effect of Pre-Operative Peri-Lymphatic Ultralow Dose IRX-2 (With Cyclophosphamide, Indomethacin, and Zinc) in Patients With Resectable Cancer of the Head and NeckAnticipated start date:
6/21/2005Lead Sponsor:
IRX TherapeuticsInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- To demonstrate the safety of the IRX-2 regimen when used as neoadjuvant (preoperative) therapy in a multi-institutional study in the patient population to be studied in a future, randomized Phase 3 trial
Secondary Outcomes:
- Estimate event-free survival (EFS) (defined as time from cyclophosphamide administration to death or clinically apparent, biopsy confirmed recurrent or progressive disease after the completion of initial therapy
- Investigate whether clinical or histological tumor response or improvement in immune competence correlate with EFS and OS
- Evaluate the clinical and histological tumor responses in patients treated with the IRX-2 regimen as evidence of biological activity
- Evaluate patient tolerance of surgery and post-operative adjuvant therapy
- Assess measures of immune competence following administration of the IRX-2 regimen, including total lymphocyte count, peripheral T-cell count and subpopulation studies, and skin test reactivity
Total Number to be Enrolled:
30Total Number to be Enrolled at Stanford:
5More Information
Publications About this Study:
- 9593347: Meneses A, Verastegui E, Barrera JL, Zinser J, de la Garza J, Hadden JW. Histologic findings in patients with head and neck squamous cell carcinoma receiving perilymphatic natural cytokine mixture (IRX-2) prior to surgery. Arch Pathol Lab Med. 1998 May;122(5):447-54.
- 10722007: Barrera JL, Verastegui E, Meneses A, Zinser J, de la Garza J, Hadden JW. Combination immunotherapy of squamous cell carcinoma of the head and neck: a phase 2 trial. Arch Otolaryngol Head Neck Surg. 2000 Mar;126(3):345-51.
- 12860165: Meneses A, Verastegui E, Barrera JL, de la Garza J, Hadden JW. Lymph node histology in head and neck cancer: impact of immunotherapy with IRX-2. Int Immunopharmacol. 2003 Aug;3(8):1083-91.
Secondary ID(s):
- 96011
- ENT0018
- IRX-2 2005-A
- NCT00210470
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
4/17/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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