ACTRN12614001181695招募中1 期
A pilot study to assess the safety and feasibility of stereotactic ablative body radiosurgery combined with MK-3475 in patients with oligometastases from breast cancer.
Peter MacCallum Cancer Centre0 个研究点目标入组 15 人开始时间: 2014年11月11日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Be willing and able to provide written informed consent/assent for the trial.
- •2. Be 18 years of age on day of signing informed consent.
- •3. Have histologically or cytologically confirmed breast cancer. Oligometastatic lesions do not need to be biopsied but they must be strongly suspected to represent metastatic disease.
- •4. CT scan (Chest, Abdo + Pelvis), Whole Body Bone scan, and FDG-PET scan evidence of 1 to 5 metastases within 8 weeks of study registration.
- •Note: At least 1 of the 5 metastases must be deemed suitable for SABR treatment.
- •5. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumour lesion. Newly-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1. Participants for whom newly-obtained samples cannot be provided (e.g. inaccessible or participant safety concern) may submit an archived specimen only upon agreement from the study P.I’s.
- •6. Have a performance status of 0-2 on the ECOG Performance Scale.
- •7. Demonstrate adequate organ function.
- •8. Life expectancy > 12 months.
- •9. Be willing and able to comply with all study requirements, including treatment, attending assessments and follow-up.
- •10. Female patients of childbearing potential must have a negative urine or serum pregnancy within 7 days of study registration and re-tested within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •11. Female patients of childbearing potential must be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through to 120 days after the last dose of MK-3475. Patients of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.
- •12. Male patients must agree to use an adequate method of contraception starting with the first SABR treatment, through to 120 days after the last dose of MK-3475.
排除标准
- •1. Previous high dose radiotherapy (BED > 20Gy) to an area to be treated which includes vertebral bodies.
- •2. Evidence of brain metastases.
- •3. Intention to treat with any chemotherapy agent within +/- 3 weeks of study treatment.
- •4. Evidence of Spinal Cord Compression.
- •5. Spinal Instability Neoplastic Score greater than or equal to 7 unless lesion reviewed by a neurosurgical service and considered stable. A dose of 28Gy in 2 fractions can be considered after review at SABR chart round.
- •6. Surgical fixation of bone lesion required for stability.
- •7. Lytic metastases in a long bone (femur or humerus) that erodes the cortex.
- •8. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and is planned to receive study therapy or used an investigational device within 4 weeks of study treatment.
- •9. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy at time of study registration.
- •10. Has a plan to receive or did receive a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study treatment or has not recovered from adverse events (i.e. AEs not at = Grade 1 or at baseline values) due to agents administered more than 4 weeks earlier.
- •11. Is planned to receive chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study treatment or who has not recovered from adverse events (i.e. AEs not at = Grade 1 or at baseline values) due to a previously administered agent.
- •12. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
- •13. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to study registration and any neurological symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
- •14. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- •15. Has known history of, or any evidence of active, non-infectious pneumonitis.
- •16. Has an active infection requiring systemic therapy.
- •17. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient’s participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator.
- •18. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- •19. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting w
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