Status:
RECRUITING
Intravenous Ascorbate Plus Gemcitabine/Carboplatin: A Novel and Cost-Effective Alternative With Evident Efficacy in Patients With Muscle Invasive Bladder Cancer
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Bladder Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 down...
Detailed Description
The investigator has hypothesized adding IVC to carbo/gem NAC will enhance pathological downstaging and improve QOL. The patients eligible for this study (cisplatin ineligible or declined with MIBC) t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Simultaneously enrolled in any therapeutic clinical trial
- Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
- Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
- Is pregnant or breastfeeding. There is a potential for congenital abnormalities and for this regimen to harm breast feeding infants
- Women of childbearing age expecting to conceive children while receiving study treatment and for 6 months after the last dose of study treatment. Men expecting to conceive children while receiving study treatment and for 3 months after the last dose of study treatment
- Has a severe known allergic reaction to any excipient contained in the study drug formulation
- Active Grade 3 or 4 (per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0109) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment.
- Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, as determined per treating physician.
- Histology of pure adenocarcinoma, pure squamous cell carcinoma, or pure small cell carcinoma in the TURBT sample
- Current consumption of tobacco products, patients may be asked to quit for 2 weeks prior to enrollment
- If tobacco use is suspected at any point during the trial, cotinine level will be obtained
- History of G6PD deficiency
- History of oxalate renal calculi - per discretion of treating physician
Key Trial Info
Start Date :
January 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06493370
Start Date
January 16 2025
End Date
December 1 2030
Last Update
February 20 2025
Active Locations (2)
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1
Holden Comprehensive Cancer Center - The University of Iowa
Iowa City, Iowa, United States, 52242
2
The University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160