Clinical trial NCT06704191: In-home Intravesical Chemotherapy for the Treatment of Bladder Cancer, INVITE Trial
Official title: MC240502: Cancer CARE (Connected Access and Remote Expertise) Beyond Walls In-home iNtraVesIcal ThErapy (INVITE) Study - A Phase Ib/II, Single-Arm Trial of Delivering Intravesical Therapy for Bladder Cancer in Patients' Homes
Conditions: Non-Muscle Invasive Bladder Carcinoma
Stage 0a Bladder Cancer AJCC v8
Stage I Bladder Cancer AJCC v8
Stage 0is Bladder Cancer AJCC v8
Summary: This phase Ib/II trial compares the safety, tolerability and acceptability of intravesical chemotherapy given at home to in-clinic administration in patients with non-muscle invasive bladder cancer. Chemotherapy drugs, such as bacillus Calmette-Guerin (BCG), gemcitabine, docetaxel, and mitomycin C, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Standard of care chemotherapy for non-invasive bladder cancer is usually given directly into the bladder through a catheter (intravesical). This process requires numerous visits and can be disruptive to the lives of patients and caregivers. Bringing cancer care to the patients with in-home intravesical therapy may help reduce the disruption to daily lives. In-home intravesical chemotherapy may be safe and tolerable and may also be preferable to in-clinic administration in patients with non-muscle invasive bladder cancer.
Interventions:
description: Given intravesically
name: BCG Solution
other_name: Bacillus Calmette Guerin Solution
Bacillus Calmette-Guerin Solution
TICE BCG Solution
type: Biological
description: Undergo cystoscopy
name: Cystoscopy
other_name: CS
type: Procedure
description: Given intravesically
name: Docetaxel
other_name: Docecad
RP 56976
RP-56976
RP56976
Taxotere
Taxotere Injection Concentrate
type: Drug
description: Given intravesically
name: Gemcitabine
other_name: Difluorodeoxycytidine
dFdC
dFdCyd
type: Drug
description: Receive access to CCBW home health visits
name: Home Health Encounter
other_name: HH
Home
Home Care Visit
Home Health
type: Other
description: Given intravesically
name: Mitomycin
other_name: Ametycine
Jelmyto
MITO
Mito-C
Mito-Medac
Mitocin
Mitocin-C
Mitolem
Mitomycin C
Mitomycin pyelocalyceal
Mitomycin-C
Mitomycin-X
Mitomycine C
Mitosol
Mitozytrex
Mutamycin
Mutamycine
NCI-C04706
type: Drug
description: Ancillary studies
name: Questionnaire Administration
type: Other
Study arms:
design_group_description: INDUCTION (PHASE IB COHORT AND PHASE II COHORT): Patients receive BCG intravesically over 1-2 hours, gemcitabine intravesically over 1-2 hours, gemcitabine intravesically over 1 hour followed by docetaxel intravesically over 1 hour or mitomycin C intravesically over 1-2 hours in the urology clinic. Treatment repeats once weekly in the home for up to 5 weeks in the absence of disease progression or unacceptable toxicity.<br/>MAINTENANCE (PHASE II COHORT ONLY): Patients receive in-home BCG intravesically over 1-2 hours once weekly for 3 weeks, gemcitabine intravesically over 1-2 hours once monthly for 3 months, gemcitabine intravesically over 1 hour followed by docetaxel intravesically over 1 hour once monthly for 3 months or mitomycin C intravesically over 1-2 hours once monthly for 3 months in the absence of disease progression or unacceptable toxicity.<br/>Additionally, patients undergo cystoscopy at end of study and receive access to CCBW home health visits throughout the study.
design_group_title: Treatment (BCG, gemcitabine, docetaxel, mitomycin)
design_group_type: Experimental
Sponsor: Mayo Clinic
Collaborators: National Center for Advancing Translational Sciences
Drug name mappings:
name: 丝裂霉素
lang: CN
name: Mitomycin
lang: EN
name: マイトマイシンC
lang: JP
name: 盐酸吉西他滨
lang: CN
name: Gemcitabine Hydrochloride
lang: EN
name: ゲムシタビン塩酸塩
lang: JP
name: 多西他赛
lang: CN
name: Docetaxel
lang: EN
name: ドセタキセル
lang: JP