- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00253474
PEG-Interferon Alfa-2b in Treating Young Patients With Plexiform Neurofibroma
A Phase I Trial of Peginterferon Alfa-2b (PEG-Intron) for Plexiform Neurofibromas
RATIONALE: PEG-interferon alfa-2b may interfere with the growth of tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of PEG-interferon alfa-2b in treating young patients with plexiform neurofibroma.
연구 개요
상세 설명
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of PEG-interferon alfa-2b in patients with unresectable plexiform neurofibroma. (Dose escalation portion of study closed to accrual as of 2/2005.)
- Determine the toxicity profile of this drug in these patients.
Secondary
- Obtain, preliminary, information about the efficacy of this drug in these patients.
- Evaluate the growth rate of plexiform neurofibroma using volumetric MRI analysis in patients treated with this drug.
- Evaluate the impact of this drug, in terms of "worst symptom" score, in these patients.
OUTLINE: This is a dose-escalation, multicenter study. (Dose-escalation portion of the study closed to accrual as of 2/2005.)
Patients receive PEG-interferon alfa-2b subcutaneously once weekly for 2 years in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of PEG-interferon alfa-2b until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 6 patients experience dose-limiting toxicity. A total of 12 patients receive treatment at the MTD.
After completion of study treatment, patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
연구 유형
등록 (예상)
단계
- 1단계
연락처 및 위치
연구 장소
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District of Columbia
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Washington, District of Columbia, 미국, 20010-2970
- Children's National Medical Center
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Illinois
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Chicago, Illinois, 미국, 60614
- Children's Memorial Hospital - Chicago
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Maryland
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Bethesda, Maryland, 미국, 20892-1182
- Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국, 15213
- Children's Hospital of Pittsburgh
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS:
- Diagnosis of plexiform neurofibroma which is progressive, symptomatic, or life threatening and for which there is no other standard medical management or surgical option
Histologic confirmation of tumor is not required in the presence of consistent clinical and radiographic findings provided the following are true:
- No clinical observation or scan suggestive of malignant transformation
Meets ≥ 1 of the following diagnostic criteria for neurofibroma type 1 (NF1):
- Six or more cafe-au-lait spots (> 0.5 cm in prepubertal patients or > 1.5 cm in post pubertal patients)
- Freckling in axilla or groin
- Optic glioma
- Two or more Lisch nodules
- A distinctive bony lesion (e.g., dysplasia of the sphenoid bone, dysplasia, or thinning of long bone cortex)
- A first degree relative with NF1
- No history of malignant peripheral nerve sheath tumor
- No active visual pathway glioma
- No active brain tumor or brain metastases
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-2
Life expectancy
- At least 12 months
Hematopoietic
- Absolute neutrophil count > 1,500/mm^3
- Hemoglobin > 10 g/dL
- Platelet count > 100,000/mm^3
Hepatic
- Bilirubin < 1.5 mg/dL
- SGPT ≤ 2 times upper limit of normal
- No significant hepatic dysfunction
Renal
Creatinine based on age as follows:
- ≤ 0.8 mg/dL (for patients age 5 years and under)
- ≤ 1.0 mg/dL (for patients age 6 to 10 years)
- ≤ 1.2 mg/dL (for patients age 11 to 15 years)
- ≤ 1.5 mg/dL (for patients age 16 to 21 years) OR
- Creatinine clearance ≥ 70 mL/min
Cardiovascular
- No significant cardiac dysfunction
- No severe cardiovascular disease
- No cardiac arrhythmia requiring chronic treatment
- No congestive heart failure
- No symptomatic ischemic heart disease
Pulmonary
- No significant pulmonary dysfunction
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No serious infection
- No other significant unrelated systemic illness
- No significant organ dysfunction
- No other malignancy except surgically cured nonmelanoma skin cancer or carcinoma in situ of the cervix
- No history of severe psychiatric condition or psychiatric disorder requiring hospitalization
- No history of suicidal ideation or attempt
- No thyroid dysfunction unresponsive to therapy
- No uncontrolled diabetes mellitus
- No history of HIV positivity
- No alcohol or drug abuse
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent immunotherapy
- No concurrent colony-stimulating factors (e.g., erythropoietin or filgrastim [G-CSF])
Chemotherapy
- No concurrent chemotherapy for this disease
Endocrine therapy
- No concurrent chronic systemic corticosteroids
- No concurrent hormonal therapy for this disease
Radiotherapy
- No concurrent radiotherapy for this disease
Surgery
- Prior surgery allowed provided it has been at least 21 days since surgery and there is presence of residual tumor
Other
- Recovered from prior therapy
- More than 30 days since prior investigational agents
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 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
- 050232
- 05-C-0232
- NCI-P6670
- CDR0000448811
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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