NCT03468075

Gemcitabine Plus Ascorbate for Sarcoma in Adults

A Phase II Trial of Gemcitabine Plus High-Dose Ascorbate in Locally Advanced Unresectable or Metastatic Soft Tissue and Bone Sarcomas in Adults

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Mohammed Milhem, MBBS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will enroll patients who have a diagnosis of locally advanced, unresectable or metastatic soft tissue or bone sarcoma (except gastrointestinal stromal tumors and Kaposi's sarcoma) from any site.

Detailed description

This study will enroll male and female patients 18 years old or older who have a diagnosis of locally advanced, unresectable or metastatic soft tissue or bone sarcoma (except GIST and Kaposi's) from any site. A minimum of 1 prior chemotherapy regimen, including adjuvant and neo-adjuvant therapy for the treatment of sarcoma, must have been given. Patients eligible for an anthracycline should have received a prior anthracycline containing regimen. Patients who decline or are not eligible for anthracycline treatment may be considered for this protocol as a first line treatment. Patients with a diagnosis of liposarcoma should also have received eribulin. During screening, subjects will receive a test dose (15g) of ascorbate. If the test dose results in any toxicity \>/= CTCAE grade 3 or a significant medical event in the opinion of the principal investigator, the patient will be considered a screen failure. Subjects who pass screening will then receive ascorbate, 75g, on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Gemcitabine will be administered on Days 1, 8 and 15, after the infusion of ascorbate. Concomitant treatment will continue for at least 6 cycles. Patients whose disease has not progressed while receiving gemcitabine and ascorbate and who are tolerating therapy may continue either single agent gemcitabine or concomitant treatment beyond 6 cycles at the discretion of the investigator. Treatment will be terminated with progression of disease. Disease will be assessed by CT of the chest, abdomen and pelvis or MRI of the lesion every 2 cycles for progression.

Conditions

• Sarcoma
• Soft Tissue Sarcoma
• Unresectable Soft Tissue Sarcoma
• Metastatic Bone Tumor
• Bone Sarcoma

Interventions

Type	Name	Description
DRUG	Ascorbate	Following 15g test dose, 75g administered on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle
DRUG	Gemcitabine	Administered on Days 1, 8 and 15, after the infusion of ascorbate

Timeline

• Start date: 2018-07-11
• Primary completion: 2019-04-16
• Completion: 2020-10-19
• First posted: 2018-03-16
• Last updated: 2020-12-10
• Results posted: 2020-12-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study