Health Condition 1: null- Muscle Invasive Urothelial Carcinoma of Urinary Bladder
Conditions
Interventions
Intervention1: Hydroxychloroquin 600 mg BD daily for 12 weeks: Gemcitabine 100mg/m2 and Cisplatin 60mg/m2 3cycles of 21 days duration
Control Intervention1: Not applicable: Single-arm open label trial
Sponsors
SERB
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed muscle invasive transitional cell carcinoma of the bladder 2. MIBC Clinical stage T2b through T4a N0/X M0 disease qualifying for neoadjuvant chemotherapy 3. Both male and female participants, aged >= 18 years
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity to HCQ 2. Chronic and serious hepatic disease with impaired hepatic function 3. Chronic and serious renal disease with impaired renal function 4. Chronic and serious gastro-intestinal disease 5. Chronic Neurological disease (including epilepsy) 6. Chronic and serious hematological disease 7. Psoriasis 8. Porphyria 9. G6PD deficiency 10. Prior systemic chemotherapy (prior intravesical therapy is allowed) 11. Serious intercurrent psychiatric illness. 12. Prior radiation therapy to the bladder. 13. Concomitant use of any other investigational drugs 14. Any of the following within the 6 months prior to study drug administration: myocardial infarction, grade 2 or greater peripheral vascular disease, arterial thrombotic event, visceral arterial ischemia, cerebrovascular ischemia, transient ischemic attack, percutaneous transluminal angioplasty or stent, or unstable angina. 15. Symptomatic and/or serious uncontrolled arrhythmia 16. Symptomatic congestive heart failure 17. History of interstitial lung disease e.g. pneumo nitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. 18. Major surgery requiring general anesthesia within 21 days or minor surgery within 14 days of study enrollment. Subjects must have recovered from surgery related toxicities. 19. Pulmonary embolism, deep vein thrombosis, or other significant venous event 19. Active infection requiring systemic treatment or any uncontrolled infections 20. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness. 21. Concurrent treatment on another clinical trial. Supportive care trials, surgical clinical trials or non-treatment trials, e.g. QOL, are allowed. 22. Ongoing treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg daily for thromboembolic prophylaxis is allowed). 23. Pregnancy or breast-feeding. All female patients would undergo pregnancy test before start of therapy. Alternatively they may be surgically sterile or be postmenopausal, or must agree to use effective contraception during the period of therapy Male patients must be surgically sterile or agree to use effective contraception. 24. History of any medical or psychiatric condition or laboratory abnormality that in the opinion of the investigator may increase the risk associated with the study participation or investigational product(s) administration or may interfere with the interpretation of the results. Concurrent treatment on another clinical trial. Supportive care trials, surgical clinical trials or non-treatment trials, e.g. QOL, are allowed. 26. Ongoing treatment with therapeutic doses of warfarin (low dose warfarin up to 2 mg daily for thromboembolic prophylaxis is allowed).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Pathological response rate (CPRR)Timepoint: 12weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety of HCQ [Automated Threshold Visual Fields (Subjective, Functional);. Spectral-Domain Optical Coherence Tomography (Objective, Structural);Fundus Autofluorescence (Objective, Structural)] Timepoint: 1, 2, 3, 6, 12 months | — |
Countries
India
Contacts
Public ContactDr S K Singh
Post Graduate Institute of Medical Education and Research
Outcome results
None listed