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Oblimersen, Rituximab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
National Cancer Institute (NCI) tarafından yürütülen bu Faz 1/2 (Phase 1/2) çalışması, nükseden veya tedaviye dirençli agresif non-Hodgkin lenfoma hastalarında oblimersen sodyumun (G3139, bcl-2 antisens oligodeoksinükleotid, Genasense) rituksimab ve kombinasyon kemoterapisiyle birlikte verildiğinde yan etkilerini, en uygun dozunu ve ne kadar iyi çalıştığını incelemiştir. Rituksimab gibi monoklonal antikorlar kanser hücrelerini bulup öldürebilir veya onlara kanser öldürücü maddeler taşıyabilirken; ifosfamid, karboplatin ve etoposid gibi kemoterapi ilaçları hücre bölünmesini durdurur; oblimersenin ise kanser hücrelerini bu ilaçlara daha duyarlı hale getirebileceği düşünülmüştür. Çalışmaya histolojik olarak doğrulanmış agresif B hücreli non-Hodgkin lenfoma (Faz 1 için grade 3 folliküler merkez lenfoma, diffüz büyük B hücreli lenfoma, transforme folliküler lenfoma, mantle hücreli lenfoma veya primer mediastinal lenfoma gibi alt tipler) 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 aggressive B-cell non-Hodgkin's lymphoma
* Any 1 one of the following histological subtypes for phase I:
* Grade 3 follicular center lymphoma
* Diffuse large B-cell lymphoma
* Transformed follicular lymphoma
* Mantle cell lymphoma
* Primary mediastinal B-cell lymphoma
* Any 1 of the following histological subtypes for phase II:
* Diffuse large B-cell lymphoma
* Transformed follicular lymphoma
* Primary mediastinal B-cell lymphoma
* Measurable disease
* At least 1 bidimensionally measurable lesion ≥ 10 mm in longest diameter by CT scan, MRI, x-ray, or clinical exam
* Relapsed disease after 1, and only 1, prior anthracycline-based chemotherapy regimen
* No known brain metastases
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* More than 3 months
* Absolute neutrophil count ≥ 1,000/mm\^3\*
* Platelet count ≥ 100,000/mm\^3\*
* Bilirubin normal\*\*
* AST and ALT ≤ 2.5 times upper limit of normal
* PT and PTT normal
* Creatinine normal
* Creatinine clearance ≥ 60 mL/min
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of allergic reactions attributed to compounds of similar chemical or biological composition to oblimersen or other study drugs
* No currently active second malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix
* Must have completed any prior therapy for a second malignancy and is considered to be at \< 30% risk of relapse
* No ongoing or active infection
* No psychiatric illness or social situation that would preclude study compliance
* No other concurrent uncontrolled illness
* Prior rituximab allowed
* No other concurrent immunotherapy
* See Disease Characteristics
* At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
* No other concurrent chemotherapy
* No concurrent hormonal therapy
* At least 4 weeks since prior radiotherapy and recovered
* No concurrent therapeutic radiotherapy
* At least 4 weeks since prior surgery
* No prior oblimersen or other antisense oligonucleotide therapy
* No other concurrent anticancer agents or therapies
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No other concurrent investigational agents