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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Porfiromycin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Porfiromycin | Drug |
|
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patients who meet any of the following clinical laboratory criteria:
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
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D011160 | Porfiromycin |
| ID | Term |
|---|---|
| D008937 | Mitomycins |
| D045563 | Indolequinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
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| D001389 |
| Azirines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |