- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00635245
CP-751871 In Treating Women With Early-Stage Breast Cancer That Can Be Removed By Surgery
A Phase 1 Pharmacodynamic Study Of CP-751,871 As Neoadjuvant Treatment For Early Breast Cancer
RATIONALE: Monoclonal antibodies, such as CP-751871, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase I trial is studying the side effects and best way to give CP-751871 in treating patients with early-stage breast cancer that can be removed by surgery.
연구 개요
상태
정황
상세 설명
Primary
- To evaluate the change in total tumor choline levels in women with operable early breast cancer in response to neoadjuvant CP-751871 treatment.
Secondary
- To assess changes in tumor glucose levels after CP-751871 treatment using magnetic resonance spectroscopy in these patients.
- To assess the safety, tolerability, and immunogenicity of CP-751871 in these patients.
- To assess the effect of CP-751871 on Insulin-like Growth Factor 1 receptor (IGF-1R) signaling markers in tumor tissues in these patients.
- To assess the clinical efficacy of CP-751871 in these patients (MRI and pathological responses).
OUTLINE: Patients receive CP-751871 IV over 5 hours on days 1 and 22 and undergo magnetic resonance spectroscopy on days 8 and 29. Patients may also undergo surgery between days 29-43 to obtain a tumor sample for analysis of markers related to the IGR-1R pathway.
After completion of study treatment, patients will be followed for 5 months.
연구 유형
단계
- 1단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Histologically confirmed early operable adenocarcinoma of the breast
- No evidence of invasive lobular breast disease
- Measurable disease, defined as at least 1 lesion ≥ 2 cm by MRI
- Measurable levels of total choline according to institutional criteria by magnetic resonance spectroscopy
- Must have available or scheduled core breast biopsy procedure
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- ECOG performance status 0-1
- Platelet count ≥ 100,000/mm^³
- Neutrophil count ≥ 1,500/mm³
- Creatinine < 1.5 times upper limit of normal (ULN)
- Bilirubin < 1.5 times ULN
- ALT and AST < 2.5 times ULN
- Fertile patients must use adequate barrier method contraception during and for at least 150 days after completion of study treatment
- Ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
- No known hypersensitivity to monoclonal antibodies
- No prior or active malignancies other than curatively treated in situ carcinoma of the cervix, uterus, or basal cell or squamous cell carcinoma of the skin
- No serious uncontrolled medical disorder or active infection that would impair the ability to receive study treatment
No significant active cardiac disease including any of the following:
- Uncontrolled high blood pressure (i.e., systolic blood pressure [BP] > 160 mm Hg and diastolic BP > 95 mm Hg)
- Unstable angina
- Deep venous thrombosis
- Pulmonary embolism
- Cerebrovascular attack
- Valvular disease
- Congestive heart failure
- Myocardial infarction with the past 6 months
- Serious cardiac arrhythmias
- No dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with study requirements
PRIOR CONCURRENT THERAPY:
- More than 4 weeks since prior surgery and recovered
- More than 2 weeks since high-dose corticosteroid therapy (i.e., ≥ 100 mg prednisone per day or > 40 mg dexamethasone per day)
- No prior anti-IGF-1R based investigational therapy
- No prior systemic therapy for primary disease
No concurrent chronic systemic high-dose immunosuppressive steroid therapy
- Low-dose steroids for nausea and vomiting control allowed
- Topical corticosteroid applications, inhaled sprays, eye drops or local injections (e.g., intraocular) allowed
- No concurrent other anticancer drugs or therapy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 마스킹: 없음(오픈 라벨)
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
---|
Tumor total choline (tCho) changes determined by magnetic resonance spectroscopy
|
2차 결과 측정
결과 측정 |
---|
병리학적 반응
|
Safety, tolerability and human anti-human antibodies (HAHA) response
|
Tissue markers
|
Measure of tumor glucose levels
|
Tumor size by MRI
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Douglas Yee, MD, Masonic Cancer Center, University of Minnesota
연구 기록 날짜
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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