NCT01017601终止2 期
A Randomized Double-Blinded Phase II Study of NTX-010, a Replication-Competent Picornavirus, After Standard Platinum-Containing Cytoreductive Induction Chemotherapy in Patients With Extensive Stage Small Cell Lung Cancer
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 59
- 试验地点
- 196
- 主要终点
- Progression-free Survival
研究概览
简要总结
RATIONALE: A virus called Seneca Valley virus-001 (NTX-010) may be able to kill tumor cells without damaging normal cells. It is not yet known whether NTX-010 is more effective than a placebo in treating small cell lung cancer.
PURPOSE: This randomized phase II trial is studying NTX-010 to see how well it works compared with a placebo when given after chemotherapy in treating patients with extensive-stage small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To compare the progression-free survival (PFS) of patients with extensive-stage small cell lung cancer treated with Seneca Valley virus-001 (NTX-010) vs placebo.
Secondary
- To compare the overall survival (OS) of patients treated with NTX-010 vs placebo.
- To describe the adverse events profile and safety of NTX-010 in this patient population.
- To determine the antitumor response rate, as assessed by RECIST criteria, and duration of tumor response in this patient population.
- To assess the quality of life of this patient population.
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
- Double (Participant, Investigator)
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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed diagnosis of extensive-stage small cell lung cancer (SCLC)
- •No mixed histology
- •Presence of ≥ 1 neuroendocrine marker (synaptophysin, chromogranin, or CD56) in tumor tissue
- •Achieved partial response (PR), complete response (CR), or stable disease (SD) ≤ 12 weeks of completing 4-6 courses of platinum-based chemotherapy regimen for extensive-stage SCLC
- •Patients with PR or SD must have measurable disease, defined as ≥ 1 lesion whose longest diameter can be accurately measured as ≥ 2.0 cm but < 10 cm by chest x-ray OR as ≥ 1.0 cm but < 10 cm by CT scan, CT component of a PET/CT scan, or MRI
- •If CT scan is used, it must be used for both pre- and post-treatment tumor assessments
- •Measurable disease is not required for patients with CR
- •Brain metastases allowed provided they have been stable for ≥ 4 weeks after completion of prior radiotherapy
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0 or 1
- •Life expectancy of ≥ 8 weeks
- •ANC ≥ 1,500/μL
- •Platelet count ≥ 100,000/μL
- •Hemoglobin ≥ 9 g/dL
- •Total bilirubin ≤ 1.5 times upper limit of normal (ULN) OR direct bilirubin normal
- •AST ≤ 3 times ULN (≤ 5 times ULN if liver has tumor involvement)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use adequate contraception
- •Able to comply with study procedures to minimize virus exposure to others
- •Willing to provide required biologic specimens
- •Willing to return to NCCTG/CTSU enrolling institution for follow-up
- •Adequate lung function (i.e., not oxygen dependent)
- •The patient is eligible if not on a 24-hour oxygen schedule
- •No second primary malignancy within the past 5 years, except for the following:
- •Carcinoma in situ of the cervix
- •Non-melanomatous skin cancer
- •History of low-grade (Gleason score ≤ 6) localized prostate cancer (even if diagnosed < 5 years prior to study entry)
- •Stage I breast cancer that was treated ≥ 5 years before study entry
- •Transitional cell carcinoma of the bladder (in situ)
- •No active hepatitis B or hepatitis C
- •No clinically significant infection
- •No significant traumatic injury within the past 4 weeks
- •No concurrent uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •More than 4 weeks since prior radiotherapy (2 weeks for palliative radiotherapy to skeletal metastases)
- •Other prior radiation therapy (including WBRT, PCI, or Gamma Knife) is permitted as long as the following are true:
- •Recovered from prior radiotherapy (alopecia allowed)
- •No prior consolidation radiation therapy to the chest
- •No prior radiotherapy to > 25% of bone marrow
- •For patients without brain metastases, WBRT or standard of care PCI completed ≥ 2 weeks before administration of NTX- 010/placebo
- •More than 365 days since prior immunotherapy or biologic therapy
- •More than 4 weeks since prior major surgery* (i.e., laparotomy) or open biopsy
- •More than 2 weeks since prior minor surgery*
- •No prior exposure to the Seneca Valley virus (NTX-010), as determined by negative serum antibodies
- •No concurrent combination antiretroviral therapy for HIV-positive patients NOTE: *Insertion of a vascular access device is not considered major or minor surgery.
排除标准
- 未提供
研究组 & 干预措施
Arm II
Placebo Comparator
Patients receive a single dose of placebo IV over 1 hour on day 1.
干预措施: placebo (Other)
Arm I
Experimental
Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
干预措施: Seneca Valley virus-001 (Biological)
结局指标
主要结局
Progression-free Survival
时间窗: Time from randomization to the disease progression or death (up to 5 years)
The progression-free survival (PFS) was defined as the time from date of randomization to the documentation of disease progression or death as a result of any cause, whichever comes first.
次要结局
- Number of Participants With at Least One Grade 3 or Above Adverse Events Assessed by NCI CTCAE v4.0(Up to 23 months)
- Clinical Significance Change From Baseline to Day 30-59 in the LASA QOL(Day 1 Cycle 1 prior to treatment (baseline) and day 30-59 (during the active monitoring phase))
- Overall Survival(Time from randomization to death or last follow-up (up to 5 years))
- Response Rate (Complete Response and Partial Response) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST)(Up to 5 years)
- Duration of Response(Up to 5 years)
- Change From Baseline to Day 20-29 in the LASA QOL(Day 1 Cycle 1 prior to treatment (baseline) and day 20-29 (during the active monitoring phase))
- Change From Baseline to Day 30-59 in the LASA QOL(Day 1 Cycle 1 prior to treatment (baseline) and day 30-59 (during the active monitoring phase))
- Clinical Significance Change From Baseline to Day 20-29 in the LASA QOL(Day 1 Cycle 1 prior to treatment (baseline) and day 20-29 (during the active monitoring phase))
研究者
研究点 (196)
Loading locations...
相似试验
已完成
1 期
Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine FeaturesNeuroblastomaRetinoblastomaGastrointestinal Carcinoid TumorKidney CancerAdrenocortical CarcinomaSarcomaNCT01048892Children's Oncology Group22
已完成
1 期
Recombinant Measles Virus Vaccine Therapy and Oncolytic Virus Therapy in Treating Patients With Progressive, Recurrent, or Refractory Ovarian Epithelial Cancer or Primary Peritoneal CancerPrimary Peritoneal Cavity CancerOvarian CancerNCT00408590Mayo Clinic37
进行中（未招募）
1 期
A Phase 2 Study to Evaluate Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib In Patients with BRCA or ATM Mutant Tumorslocally advanced (primary or recurrent) or metastatic solid tumors with a pathogenic or likely pathogenic germline or loss-of-function somatic BRCA1, or BRCA2, or ATM gene defectMedDRA version: 20.0 Level: LLT Classification code 10065147 Term: Malignant solid tumor System Organ Class: 100000004864MedDRA version: 20.0 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 100000004864EUCTR2018-000345-39-NLPfizer Inc., 235 East 42nd Street, New York, NY 10017541
已完成
2 期
A Phase 2 Study to Evaluate Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib In Patients with BRCA or ATM Mutant Tumorslocally advanced or metastatic solid tumorsmaligne tumor10027655NL-OMON48840Pfizer22
进行中（未招募）
1 期
A Phase 2 Study to Evaluate Safety and Anti-tumor Activity of Avelumab in Combination with Talazoparib In Patients with BRCA or ATM Mutant Tumorslocally advanced (primary or recurrent) or metastatic solid tumors with a pathogenic or likely pathogenic germline or loss-of-function somatic BRCA1, or BRCA2, or ATM gene defectMedDRA version: 20.0Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864MedDRA version: 20.0Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864EUCTR2018-000345-39-FRPfizer Inc., 235 East 42nd Street, New York, NY 10017541