Pilot Study of the Intravesical Administration of EOquin Immediately Following Transurethral Resection in Patients with Superficial Bladder Cancer. - Not applicable

Spectrum Pharmaceuticals, Inc.0 个研究点目标入组 20 人开始时间: 2006年6月28日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•All of the following inclusion criteria must be met in order for the patient to be eligible for the study:
•1. Transitional-cell carcinoma of the bladder, clinical TNM stage Ta or T1 and histologic grade G1 or G2 before transurethral resection.
•2. Absolute neutrophil count =1.5 x109/L, platelets = 100 x109/L, serum creatinine and bilirubin = 1.5 x upper limit of local norm (ULN), serum GOP and GPT = 3 xULN
•3. Women of child-bearing age must have a negative pregnancy test.
•4. All patients must agree to use an effective method of contraception
•5. ECOG performance status of 0-2
•6. Age =18
•7. Patient fully informed of the investigational nature of the study; signed written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. Likelihood of muscle-invasive (T2) or higher stage disease, or carcinoma in situ.
•2. Recurrence within 3 months from the last previous manifestation of SBC
•3. More than 5 lesions or largest diameter = 4 cm
•4. Prior intravesical treatment (chemotherapy or immunotherapy) within the last 3 months
•5. Previous treatment with EOquin™ by intravesical or intravenous administration
•6. Patients with other malignancies except resected basal cell cancer/squamous carcinoma of the skin
•7. Patients with any significant GU disease
•8. Patients with prior intravesical BCG therapy
•9. Patients with bladder perforation, suspected bladder perforation, or deep resection exposing perivesical fat.
•10. Active urinary tract infection or recurrent severe bacterial cystitis
•11. Urogenital tumors with histology other than transitional cell carcinoma (i.e., squamous cell or adenocarcinoma) or with transitional carcinoma involving the upper tract or the prostatic urethra
•12. Patients who, in the opinion of the investigator, cannot tolerate general anesthesia, intravesical administration or intravesical surgical manipulation (cystoscopy, biopsy) due to the presence of concomitant serious illness (i.e. uncontrolled cardiac or respiratory disorders)
•13. Pregnancy or lactation. Any immune deficiency condition or known HIV infection
•14. Patient unlikely to comply with the provisions of the protocol

发起方