NCT02369458已完成2 期
Phase II Trial of Mitomycin C in Patients With Incurable p16 Positive Oropharyngeal and p16 Negative Head and Neck Squamous Cell Carcinoma (HNSCC) Resistant to Standard Therapies
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Tumor Response Rate (TRR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 resection).
- •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.
- •Tissue available (either initial diagnostic or recurrent tissue specimen) for p16 testing.
- •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 institutional normal
- •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).
排除标准
- •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 study requirements.
- •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.
研究组 & 干预措施
Cohort A: p16+ OPSCC
Experimental
- Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
- Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
干预措施: Mitomycin-C (Drug)
Cohort A: p16+ OPSCC
Experimental
- Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
- Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
干预措施: Pegfilgrastim (Drug)
Cohort 2: p16- HNSCC
Experimental
- Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
- Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
干预措施: Mitomycin-C (Drug)
Cohort 2: p16- HNSCC
Experimental
- Mitomycin C given on Day 1 every 5 weeks (each cycle is 5 weeks).
- Pegfilgrastim will be given on Day 2 of each cycle (subcutaneous injection)
干预措施: Pegfilgrastim (Drug)
结局指标
主要结局
Tumor Response Rate (TRR)
时间窗: Approximately 6 months (median 5.6 months with full range of 0.1-33.7 months)
* TRR will be evaluated separately in p16- (HPV-unrelated) HNSCC patients and in p16+ (HPV positive) OPSCC patients using two optimal two-stage Simon designs. In both cases, the expected TRR is 10%. A TRR of 30% is considered a clinically significant increase. * RECIST 1.1 will be used for this outcome.
Tumor Response Rate (TRR) for Participants Enrolled Post October 2020
时间窗: Approximately 6 months (median 4.0 months with full range of 0.5-12.0 months)
* TRR will be evaluated in p16+ (HPV positive) OPSCC HNSCC patients * RECIST 1.1 will be used for this outcome.
次要结局
- Progression-free Survival (PFS)(Approximately 6 months (median 5.6 months with full range of 0.1-33.7 months))
- Number of Participants With Grade 3/4/5 Adverse Events(28 days after completion of treatment (median length of follow-up was 96 days, full range of 3-463 days))
- Overall Survival (OS)(Through completion of follow-up (median length of follow-up Cohort A= 6.6 months IQR 2.7-12.0 months, median length of follow-up Cohort B=3.2 months IQR 1.5-9.4 months))
研究者
研究点 (1)
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