Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors

A Phase I Intensive Pharmacokinetic Study of Porfiromycin in Head and Neck Cancer and Other Cancer Patients With Solid Tumors Who Receive Radiation Therapy

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02209701

Enrollment

Registered

2014-08-06

Start date

1999-12-31

Completion date

Unknown

Last updated

2014-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Neoplasms

Brief summary

Study to determine the steady-state pharmacokinetics and urinary excretion of porfiromycin and major metabolites in head and neck cancer and other cancer patients with solid tumors who receive radiation therapy.

Interventions

DRUGPorfiromycin

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with histologically proven advanced head and neck cancer or other solid tumors undergoing radiation therapy * Patients with prior chemotherapy will be considered if chemotherapy occurred more than 30 days prior to this study * Patients must be receiving concomitant radiotherapy (RT) * Performance status of ≥ 70% on the Karnofsky performance scale (KPS) * Must be ≥ 18 years of age * Expected survival of at least three months * Written informed consent

Exclusion criteria

* Patients who meet any of the following clinical laboratory criteria: * Granulocyte count of \< 2000/mm\*\*3 * Platelets \< 75,000/mm\*\*3 * Serum creatinine \> 1.5 times the upper limit of normal * Bilirubin \> 1.5 times the upper limit of normal * Prothrombin time and partial thromboplastin time \> 1.5 times the upper limit of normal * Women who are pregnant * Men and women of child-bearing potential who are unwilling to utilize a medically acceptable method of contraception * Patients who have any known bleeding disorder at the discretion of the investigator * Presence of any other life-threatening illness, such as unstable angina, severe oxygen dependent chronic obstructive pulmonary disease, or unstable liver or renal disease * Treatment with granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor or Interleukin-1l within 30 days prior to the start of RT * Patients who have had prior exposure to mitomycin C or porfiromycin

Design outcomes

Primary

Measure	Time frame
Assessment of serum concentrations of the analyte	up to 6 hours after drug infusion
Amount of analyte excreted in urine	0-3 and 3-6 hours after infustion

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026