- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00004110
Monoclonal Antibody Therapy Plus Etoposide in Treating Patients With Neuroblastoma
Monoclonal Antibody 3F8 and Oral Etoposide for the Treatment of Neuroblastoma
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody therapy plus etoposide in treating patients who have neuroblastoma.
연구 개요
상세 설명
OBJECTIVES:
- Determine the antitumor effects of monoclonal antibody 3F8, etoposide, and isotretinoin using standard imaging methods and tumor marker studies in patients with high-risk neuroblastoma.
- Assess progression-free survival in these patients after this treatment.
- Assess the effects of oral etoposide on human anti-mouse antibody and anti-idiotype response in these patients.
OUTLINE: Patients are stratified according to disease status (evaluable but not measurable vs second or subsequent remission with no measurable or evaluable disease).
Patients receive monoclonal antibody 3F8 (MOAB 3F8) IV over 1.5 hours once daily on days 1-10 and oral etoposide once daily on days 29-49. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression, human anti-mouse antibody (HAMA) response, or unacceptable toxicity.
If HAMA fails to develop after completion of 4 courses of MOAB 3F8, patients continue treatment with MOAB 3F8 on days 1-5 every 8 weeks until HAMA reaches greater than 1,000 U/mL or until month 24, whichever occurs first.
Beginning after completion of 4 courses of etoposide and MOAB 3F8 or if HAMA develops, patients receive oral isotretinoin twice daily for 14 days followed by at least a 14-day rest. Treatment repeats for a total of 6 courses.
PROJECTED ACCRUAL: A total of 50 patients (25 per stratum) will be accrued for this study within 5 years.
연구 유형
단계
- 2 단계
연락처 및 위치
연구 장소
-
-
New York
-
New York, New York, 미국, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
High-risk neuroblastoma by:
- Histopathology OR
- Bone marrow involvement plus elevated urinary catecholamines
Prior tumor progression on standard chemotherapy and poor long-term prognosis as indicated by 1 or more of the following:
- N-myc amplification in tumor cells
- Diploid chromosomal content plus lp loss of heterozygosity in tumor cells
- Distant skeletal metastases
- Unresectable primary tumor infiltrating across the midline
- More than 10% tumor cells in bone marrow
- Less than 30% chance of long-term progression-free survival
- Evaluable (microscopic marrow metastasis, elevated tumor markers, abnormal bone scan or MIBG or PET scan) but not measurable (CT scan, MRI) disease documented at least 4 weeks after completion of prior systemic therapy
No rapidly progressive disease as defined by 1 or more of the following:
- Serum lactic dehydrogenase greater than 1.5 times upper limit of normal due to tumor
- An opiate requirement for pain from tumor
- Greater than 25% increase in tumor by successive imaging studies
- Life expectancy less than 8 weeks
- Second or subsequent remission after chemotherapy and/or radiotherapy allowed provided there is less than 30% chance of survival
- No prior myelodysplastic syndromes or leukemia
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Not specified
Life expectancy:
- See Disease Characteristics
- At least 8 weeks
Hematopoietic:
- Not specified
Hepatic:
- No grade 3 or worse liver toxicity
Renal:
- No grade 3 or worse renal toxicity
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No grade 3 or worse cardiac toxicity
Pulmonary:
- No grade 3 or worse pulmonary toxicity
Other:
- Not pregnant
- No grade 3 or worse gastrointestinal toxicity
- No grade 3 or worse neurologic system toxicity
- No grade 4 hearing deficit
- No active life-threatening infection
- No prior exposure to mouse antibodies and human anti-mouse antibody greater than 1,000 ELISA units/mL
- No allergy to mouse proteins
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- See Disease Characteristics
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
Surgery:
- See Disease Characteristics
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 마스킹: 없음(오픈 라벨)
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MSKCC-IRB-99033
- CDR0000067333 (레지스트리 식별자: PDQ (Physician Data Query))
- NCI-G99-1599
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. .