Phase I Safety Trial of Concurrent Adjuvant Immunotherapy and Radiation Therapy for the Treatment of Urothelial Bladder Cancer
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Urothelial Carcinoma Bladder
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Safety of concurrent adjuvant immunotherapy and radiation therapy
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief Summary
The primary objective of this Phase I study is to establish the safety of adjuvant concurrent immunotherapy and radiation therapy for urothelial bladder cancer.
Detailed Description
Patients in this study will receive the standard of care procedures and follow-up for immunotherapy and radiation therapy. The part of this study that is research is receiving both of these treatments at the same time. Safety will be based on acute toxicity.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pure or mixed variant urothelial carcinoma
- •o Allowable mixed variant subtypes include:
- •squamous differentiation
- •glandular differentiation
- •nested pattern
- •microcystic
- •micropapillary
- •lymphoepthelioma-like
- •plasmacytoid and lymphoma-like
- •sarcomatoid/carcinosarcoma
Exclusion Criteria
- •Urinary diversion with an orthotopic neobladder
- •History of inflammatory bowel disease
- •Prior partial or complete small bowel obstruction either before or after radical cystectomy
- •Prior radiotherapy to the pelvis;
- •o Prior radiation therapy for a different cancer or disease process is allowed, provided there will be no overlap of radiation therapy fields between the participant's prior and current course of radiation therapy, radiotherapy was completed more than four weeks from enrolling in this study.
- •Planned concurrent chemotherapy or other investigational drug to be given with radiation treatments
- •o Prior chemotherapy or investigational drug for bladder cancer or a different cancer is allowed, provided that:
- •The therapy was completed more than two weeks prior to the start of adjuvant pelvic radiation
- •The participant has recovered to Grade ≤1 toxicity from agents previously administered, excluding toxicities that would not be expected to impact eligibility for radiation therapy including but not limited to neuropathy, alopecia and hearing loss.
- •Subtotal surgical resection with clinically evident residual disease by physical exam or axial imaging.
Outcomes
Primary Outcomes
Safety of concurrent adjuvant immunotherapy and radiation therapy
Time Frame: Within 18 weeks from start of radiation therapy
The primary study endpoint is acute grade 3 or higher pelvic radiation related toxicity. A toxicity will be classified as related to pelvic radiation if the toxicity involves or is the result of effects on tissues that are within the 50% isodose bath of the radiation treatment as defined on the radiation treatment planning simulation scan. Toxicities will be graded by CTCAE Version 5.0. Concurrent adjuvant immunotherapy and radiation will be deemed safe if it is likely (i.e. a posterior probability of 50% or greater) that the acute grade 3 or higher pelvic radiation related toxicity rate is \<20%.