NCT04877587

Gemcitabine With Ascorbate Including Adolescents

A Pilot Study of Gemcitabine Plus High-Dose Ascorbate in Locally Advanced Unresectable or Metastatic Soft Tissue and Bone Sarcomas Including Adolescents

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: David Dickens · Academic / Other
• Sex: All
• Age: 13 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to see if a high dose of ascorbate (Vitamin C), in combination with the chemotherapy drug gemcitabine, is safe and effective in adolescents with locally advanced unresectable or metastatic soft tissue and bone sarcomas

Detailed description

The primary objective of the expansion cohort of this pilot study is to evaluate preliminary evidence of anti-tumor activity of intravenous ascorbate in combination with gemcitabine as assessed by overall response rate to inform a subsequent Phase II trial.

Conditions

• Soft Tissue Sarcoma
• Bone Sarcoma
• Unresectable Soft Tissue Sarcoma
• Metastatic Bone Sarcoma
• Metastatic Soft-tissue Sarcoma
• Unresectable Bone Sarcoma

Interventions

Type	Name	Description
DRUG	Ascorbate	A patient-individualized pharmacokinetically-guided dose escalation design will be used for Ascorbate. The goal of the within-patient dose escalation is to achieve a target plasma ascorbate level between 20mM and 30mM. The administered dose levels under consideration are listed below. Dose Level Ascorbate * 2 60 g/m2 IV Days (1,2,8,9,15,16) * 1 50 g/m2 IV Days (1,2,8,9,15,16) 0 (Starting dose) 40 g/m2 IV Days (1,2,8,9,15,16) * 1 30 g/m2 IV Days (1,2,8,9,15,16)
DRUG	Gemcitabine	Gemcitabine 900 mg/m2 given at a fixed dose rate of 10 mg/m2/min on D1, D8 and D15 to be given over 90 min every 28 days

Timeline

• Start date: 2023-01-01
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2021-05-07
• Last updated: 2023-02-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study