Intravenous Ascorbate Plus Gemcitabine/Carboplatin: A Novel and Cost-Effective Alternative With Evident Efficacy in Patients With Muscle Invasive Bladder Cancer

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a phase II, single arm, Simon two-stage design, trial, enrolling patients with cisplatin ineligible MIBC and/or those patients who decline cisplatin based NAC. Assess rates of pathologic downstaging and quality of life in MIBC cisplatin-ineligible/declined patients when IVC is added to gemcitabine-carboplatin NAC.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Ability of participant to understand this study, and participant willingness to sign a written informed consent

• Consent to participate in biorepository protocol number GUB-BCR-001, KU IRB Approved HSC # STUDY00141546

• Males and females age ≥ 18 years

• ECOG Performance Status (PS) 0 - 2

• Women of childbearing potential must have a negative serum pregnancy test 72 hours prior to initiating treatment.

• Diagnosis/disease status Cisplatin-ineligible or declined muscle invasive bladder cancer. Cisplatin ineligibility will be defined based on Galsky criteria: CTCAE ver. 5.0 Grade 2 or greater peripheral neuropathy; CTCAE ver. 5.0 Grade 2 or greater hearing loss; Creatinine clearance estimated or calculated \< 60 ml/min; NYHA class II or greater congestive heart failure

• Adequate organ function, defined as follows: Absolute Neutrophil Count \>1.5K/UL. (NOTE: Patients with established diagnosis of benign neutropenia are eligible to participate with ANC between 1000-1500 based on discretion of the treating physician.); Platelets \>100K/UL; Hemoglobin ≥ 9 g/dL; Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation; Total bilirubin ≤ 2.0 x ULN; Aspartate aminotransferase (AST \[SGOT\]) and alanine aminotransferase (ALT \[SGPT\]) ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN; Normal Glucose-6-phosphate dehydrogenase (G6PD) status

• Women of child-bearing potential (WOCBP) and men with partners of child-bearing potential must agree not to donate sperm (men), to practice sexual abstinence or to use the forms of contraception listed in Child-Bearing Potential/Pregnancy section for the duration of study participation and for WOMEN: 6 months after EOT, MEN: 3 months after EOT following completion of therapy.

Locations
United States
Iowa
Holden Comprehensive Cancer Center - The University of Iowa
NOT_YET_RECRUITING
Iowa City
Kansas
The University of Kansas Cancer Center
RECRUITING
Kansas City
Contact Information
Primary
KUCC Navigation
kucc_navigation@kumc.edu
913-588-3671
Backup
Faith Rahman
frahman2@kumc.edu
913-588-2502
Time Frame
Start Date: 2025-01-16
Estimated Completion Date: 2030-12-01
Participants
Target number of participants: 48
Treatments
Experimental: Intravenous ascorbic acid/vitamin C
2 Cycles Carboplatin Day 1 and Gemcitabine Days 1 and 8 (NAC)~\+ Intravenous Vitamin C Days 1-28
Sponsors
Leads: University of Kansas Medical Center

This content was sourced from clinicaltrials.gov

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