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Oblimersen Plus Combination Chemotherapy and Dexrazoxane in Treating Children and Adolescents With Relapsed or Refractory Solid Tumors
National Cancer Institute (NCI) tarafından yürütülen bu Faz 1 (Phase 1) çalışması, nükseden veya tedaviye dirençli solid tümörü olan çocuk ve ergenlerde oblimersen sodyumun (G3139, bcl-2 antisens oligodeoksinükleotid, Genasense) kombinasyon kemoterapisi ve deksrazoksan ile birlikte kullanılmasının etkililiğini incelemiştir. Oblimersenin tümör hücrelerini ilaca daha duyarlı hale getirerek doksorubisin ve siklofosfamidin etkisini artırabileceği, deksrazoksan gibi koruyucu ilaçların ise normal hücreleri kemoterapinin yan etkilerinden koruyabileceği düşünülmüştür. Çalışmaya, ilk tanıda histolojik olarak doğrulanmış, standart tedaviye yanıt vermemiş ya da standart tedavisi bulunmayan ve bilinen küratif seçeneği olmayan solid tümörü olan hastalar alınmıştır; çalışma tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Histologically confirmed solid tumor at original diagnosis that has failed standard therapy or for which no standard therapy exists * Patients must have a disease for which there is no known curative potential * Patients must meet the following criteria for bone marrow function: * Status post stem cell transplantation (SCT) * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 (transfusion independent) * Hemoglobin at least 8.0 g/dL (RBC transfusions allowed) * No lymphomas * No CNS tumors or known metastatic disease to the brain or spinal cord * Performance status - Karnofsky 50-100% (age 11 to 21) * Performance status - Lansky 50-100% (age 1 to 10) * At least 8 weeks * See Disease Characteristics * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * ALT no greater than 3 times ULN * No significant hepatic dysfunction * Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min * Creatinine, based on age, as follows: * Age 1 to 5: no greater than 0.8 mg/dL * Age 6 to 10: no greater than 1.0 mg/dL * Age 11 to 15: no greater than 1.2 mg/dL * Age 16 to 21: no greater than 1.5 mg/dL * No significant renal dysfunction * Shortening fraction at least 28% by echocardiogram * Ejection fraction at least 45% by MUGA * No significant pulmonary dysfunction * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No serious uncontrolled infections * No other end-organ dysfunction that would preclude study entry * No other clinically significant systemic illness * See Disease Characteristics * Recovered from prior immunotherapy * At least 1 week since prior growth factors or other biologic agents * At least 6 months since prior autologous SCT * At least 6 months since prior allogeneic bone marrow transplantation and recovered with no evidence of graft-versus-host disease * No concurrent immunomodulating agents * No concurrent prophylactic growth factors during the first course of the study * No concurrent immunotherapy or other biologic therapy * Recovered from prior chemotherapy * At least 2 weeks since prior myelosuppressive chemotherapy (6 weeks for nitrosoureas) * No prior life-time cumulative doxorubicin dose of more than 450 mg/m\^2 or equivalent * No other concurrent chemotherapy * Concurrent chronic steroids allowed * Recovered from prior radiotherapy * More than 2 weeks since prior localized palliative radiotherapy (small port) * More than 6 months since prior substantial radiotherapy to bone marrow (craniospinal radiotherapy, total body irradiation, or hemi-pelvic radiotherapy) * No concurrent radiotherapy * Concurrent chronic medications (e.g., narcotics or antiepileptics) allowed * No other concurrent investigational agents * No other concurrent cancer therapy