Yeni Tanı Almış Diffüz Pontin Tümör ve Yüksek Dereceli Astrositomu Olan Çocuk ve Genç Erişkinlerde Dış Işın Radyoterapisi ve Cetuximab Sonrası İrinotekan ve Cetuximab

Sade dilde özet

Bu çalışma, yeni tanı almış diffüz pontin tümör veya yüksek dereceli astrositom (beyin sapı/beyin tümörleri) olan çocuk ve genç erişkinlerde dış ışın radyoterapisi ve Cetuximab sonrasında İrinotekan ve Cetuximab tedavisini inceliyor. Bu tümörlerin patolojik veya MR ile tanısı konmuş hastalar dahil edilmiştir. Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

Memorial Sloan Kettering Cancer Center

Müdahale

cetuximab in conjunction with external beam radiation therapy, followed by cetuximab and irinotecan

Başlangıç

30.10.2009

Tahmini bitiş

15.01.2018

Ülkeler

United States, Canada

İlgili genler

Merkezler

• Phoenix, United States
• Denver, United States
• Gainesville, United States
• Orlando, United States
• Atlanta, United States
• Baltimore, United States
• Boston, United States
• Kansas City, United States
• New York, United States
• Houston, United States
• Seattle, United States
• Calgary, Canada

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

Inclusion Criteria:

* Patients must have either (1) histologic proof of a high-grade astrocytoma reviewed by a POETIC institutional pathologist or (2) a radiological diagnosis via MRI scan of a typical diffuse pontine tumor made by a POETIC institutional neuroradiologist. Patients with a radiological diagnosis via MRI scan of a typical diffuse pontine tumor will be enrolled on the diffuse pontine tumor arm of the study regardless of histology in cases that are biopsied. Note: For collaborating non-POETIC institutions, the reviews may be done by an institutional pathologist/neuroradiologist.
* Patients must begin study prescribed therapy within 42 days of neurosurgical resection or biopsy of the tumor (high-grade astrocytoma patients) or radiological diagnosis (diffuse pontine tumor patients).
* Age ≥ 3-years and \< 22-years-old.
* Brain MRI (and any other studies done according to clinical indications) must not show any definitive evidence of leptomeningeal or extra-neural metastases.
* ANC ≥ 1000/μL and platelet count ≥ 100,000/μL
* Patients must have adequate organ function as defined by:
* Hepatic: total bilirubin \< 1.5 mg/dl, AST ≤ 2.5 x the upper limit of normal.
* Renal: serum creatinine ≤ 1.5 x the upper limit of normal for age, or calculated creatinine clearance or nuclear GFR ≥ 70 ml/min/1.73 m2.
* The patient, or for minors, a parent or legal guardian, must give informed written consent indicating they are aware of the investigational nature of this study.

Exclusion Criteria:

* Evidence of leptomeningeal or extra-neural metastatic disease.
* Prior radiation therapy or chemotherapy
* Pregnancy, mothers unwilling to refrain from breast-feeding, and sexually mature patients unwilling to practice an effective form of birth control.
* Other significant concomitant medical illnesses that would compromise the patient's ability to receive all prescribed study therapy.
* Prior therapy which specifically and directly targets the EGFR pathway.
* Prior severe infusion reaction to a monoclonal antibody.
* Significant history of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
* Patients with known Gilbert's Syndrome.