CMV chemotherapy for pure squamous cell cancer of the urinary tract

Phase 2

Completed

• Conditions: Squamous cell carcinoma of the bladder; Cancer; Bladder cancer

• Registration Number: ISRCTN84356042
• Lead Sponsor: Medical Research Council

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/30650143 results (added 22/01/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2001-05-01
• Study Start: 2018-04-03
• Last Update Posted: 20 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Pure squamous cell carcinoma of the urinary tract in one of the following groups:
1.1. initial presentation with T3-T4 disease
1.2. pelvic relapse after radiotherapy or surgery
1.3. nodal or metastatic disease
2. At least one site of disease assessable for response by clinical examination or imaging. One or more of the sites below can be used to assess response:
2.1. primary bladder tumour (satisfactory measurements of the primary tumour if present and measureable, must have been made by bimanual examination after transurethral resection (TUR))
2.2. other primary tumours in the urinary tract (satisfactory measurements of the primary tumour in the urinary tract, if present and measureable, must have been made by clinical examination or appropriate imaging)
2.3. pelvic relapse after radiotherapy or surgery (at least one indicator lesion must be measurable by clinical examination or appropriate imaging)
2.4. nodal or metastatic disease (at least one indicator lesion must be measurable by clinical examination or appropriate imaging. NB: Bone metastases cannot be used as an indicator lesion.
3. Calculated glomerular filtration rate (GFR), calculated by the method of Cockcroft and Gault (1976) >50 ml/min. In patients with impaired renal function secondary to ureteric obstruction this may be relieved by ureteric stents or nephrostomies, and if the renal function then recovers the patient will be eligible.
4. White blood cell count >3.5 x 10(9)/l and platelet count >100 x 10(9)/l
5. No previous systemic treatment with chemotherapy
6. No concomitant or previous malignancy other than basal cell carcinoma of skin or carcinoma in-situ of the cervix
7. Fit to tolerate CMV

Exclusion Criteria

1. Transitional cell carcinoma with squamous metaplasia, or other mixed tumours
2. Co-existing illness (e.g. cardiac failure) that may compromise administration of CMV chemotherapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified