Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Closed 20 to 80 NCI YALE-HIC-4911 NCI-T88-0217D, T88-0217

Objectives

I.  Determine a safe dose and the acute effects on normal tissue of 
porfiromycin when given as an adjuvant to radiotherapy in the treatment of 
epidermoid carcinoma of the head and neck.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients 20 to 80 years of age with 
biopsy-proven epidermoid carcinoma of the head and neck limited to the oral 
cavity, pharynx, or larynx (as defined by the AJCC).  The presence of distant 
metastases excludes.  Newly diagnosed patients must present with AJCC Stage IV 
disease deemed incurable by surgery and/or radiotherapy (less than 15% 5-year 
survival) by the Joint Head and Neck Tumor Board of the Yale Comprehensive 
Cancer Center; those with advanced neck disease from an unknown primary are 
also eligible.  Patients with recurrent disease who have previously undergone 
surgery for any stage head and neck cancer are also eligible.  Patients must 
be receiving external beam radiotherapy or external beam radiotherapy with 
brachytherapy for their disease.  Surgery prior to radiotherapy is allowed, 
but there may have been no prior radiotherapy within the proposed treatment 
site and no chemotherapy during the 3 years prior to entry.  An ECOG 
performance status of 2 or better and a life expectancy of at least 6 months 
are required, as are the following laboratory parameters:  WBC at least 3,400, 
platelets greater than 125,000, hematocrit at least 34.0% in men and 31.0% in 
women, and serum creatinine and total bilirubin each less than 1.5 mg/dl.  The 
following conditions exclude:  a greater than 15% weight loss attributable to 
the present illness; known bleeding disorder; history of other active 
malignancy within the past 5 years (other than basal or squamous cell 
carcinoma of the skin outside the radiation portals or in situ carcinoma of 
the cervix); and any other life-threatening illness.

Expected Enrollment

At least 3 patients will be treated at each dose level of Porfiromycin; a 
study duration of 1 year is anticipated.  The two patient groups (external 
beam radiotherapy alone vs. external beam radiotherapy plus brachytherapy) 
will be accrued and toxicities assessed separately.

Outline

Nonrandomized study.  Patients are treated on Regimen A or B, as appropriate.
Regimen A:  Radiotherapy plus Adjuvant Single-agent Chemotherapy.  External 
beam radiotherapy using supervoltage sources with energies of at least 4 MeV; 
plus Porfiromycin, NSC-56410.
Regimen B:  Radiotherapy plus Adjuvant Single-agent Chemotherapy.  External 
beam radiotherapy as in Regimen A plus brachytherapy using temporary implants 
of Ir-192 seeds or permanent implants of I-125; plus Porfiromycin.

Trial Contact Information

Trial Lead Organizations

Yale Cancer Center

James Fischer, MD, PhD, Protocol chair		Ph: 203-785-2956; 866-925-3226