No agent is known to have efficacy in patients with incurable HNSCC that progressed with
prior platin, 5-FU, cetuximab and taxane. Herein lies the unmet need to be addressed by this
trial. Based on the preclinical and clinical data presented, the investigators propose that
mitomycin C will have anti-tumor activity in these patients.
- Histologically or cytologically confirmed incurable HNSCC of the oral cavity,
oropharynx, larynx, hypopharynx, and/or Level 1-3 neck node with non-cutaneous SCC and
unknown primary. "Incurable" is defined as metastatic disease or a local or regional
recurrence in a previously irradiated site that is unresectable (or patient declines
- Progression following platin and immunotherapy given for incurable disease.
- Measurable disease defined as lesions that can be accurately measured in at least one
dimension (longest diameter to be recorded) as ≥ 10 mm with CT scan, as ≥ 20 mm by
chest x-ray, or ≥ 10 mm with calipers by clinical exam per RECIST 1.1.
- Tissue available (either initial diagnostic or recurrent tissue specimen) for p16
- At least 18 years of age.
- ECOG performance status ≤ 3
- Adequate hematologic, renal, and hepatic function as defined below:
- Absolute neutrophil count ≥ 1,000/mcl
- Platelets ≥ 75,000/mcl
- Total bilirubin ≤ 1.5 mg/dL
- AST(SGOT)/ALT(SGPT) ≤ 2.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN, unless bone
metastasis is present in the absence of liver metastasis
- Creatinine below ULN (males 0.7-1.30 mg/dl; females 0.6-1.10 mg/dl) OR Creatinine
clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above
- Women of childbearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control, abstinence) prior to study entry, for
the duration of study participation, and for 1 month after completing treatment.
Should a woman become pregnant or suspect she is pregnant while participating in this
study, she must inform her treating physician immediately.
- Ability to understand and willingness to sign an IRB approved written informed consent
document (or that of legally authorized representative, if applicable).
- Other active malignancy with the exception of basal cell or squamous cell carcinoma of
the skin which were treated with local resection only, carcinoma in situ of the
cervix, or synchronous H&N primaries.
- Currently receiving any other investigational agents.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
- Pregnant and/or breastfeeding. Patient must have a negative pregnancy test within 7
days of start of study treatment.
- Known active central nervous system (CNS) metastases. Subjects with previously treated
brain metastases may participate provided they are stable (without evidence of
progression by imaging for at least four weeks prior to the first dose of trial
treatment and any neurologic symptoms have returned to baseline), have no evidence of
new or enlarging brain metastases, and are not using steroids for at least 28 days
prior to treatment.
- A history of allergic reactions attributed to compounds of similar chemical or
biologic composition to mitomycin C or other agents used in the study.
- Known HIV-positivity on combination antiretroviral therapy because of the potential
for pharmacokinetic interactions with the study drugs. In addition, these patients are
at increased risk of lethal infections when treated with marrow-suppressive therapy.
Appropriate studies will be undertaken in patients receiving combination
antiretroviral therapy when indicated.