Gemcitabine Plus Ascorbate for Sarcoma in Adults (Pilot)

Running, not enrolling · Early Phase 1

Conditions studied: Sarcoma, Soft Tissue Sarcoma, Unresectable Soft Tissue Sarcoma, Metastatic Bone Tumor, Bone Sarcoma

In brief

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.

Key facts

Study ID

NCT04634227

Run by

University of Iowa

People needed

30

Starts

2020-11-24

Expected to finish

2026-12-31

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients aged ≥ 18 years old
• ECOG Performance Status of ≤ 2
• Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed
• Tolerate a 15g ascorbate infusion (screening dose)
• Any patient with the 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 or neo-adjuvant therapy for the treatment of sarcoma. 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 if they received anthracycline-based therapy prior to eribulin. Patients with a diagnosis of myxoid liposarcoma should have received trabectedin. Patients with angiosarcoma should have received either taxol or docetaxel. Patients must have measurable disease defined as at least 1 lesion ≥ 1cm in the greatest dimension.
• Patients with metastatic bone sarcomas who have failed all available therapies that have demonstrated clinical benefit. Available therapies include but not limited to methotrexate, adriamycin and cisplatin for osteosarcoma and vincristine, adriamycin and Cytoxan, ifosfamide, etoposide (VAC/IE) for Ewing's sarcoma.
• Patients must have had disease progression on or following their most recent treatment regimen or on presentation for the first time with locally advanced unresectable or metastatic disease.
• Patients with NO known CNS disease, except for treated brain metastasis: Treated brain metastases are defined as having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and brain imaging (MRI or CT) during the screening period. Anticonvulsants (stable dose) are allowed. Treatment for brain metastases may include whole brain radiotherapy (WBRT), radiosurgery (RS; Gamma Knife, LINAC, or equivalent) or a combination as deemed appropriate by the treating physician. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 3 months prior to Day 1 will be excluded

You may not qualify if…

• Lab values in the below ranges:
• Neutrophil count of </=1500/mm3
• Platelet count of </= 100,000/mm3L
• Hemoglobin < 9 g/dL (transfusion to meet eligibility allowed)
• AST/SGOT and ALT/SGPT > 2.5 x upper limit of normal (ULN) or >5.0 x ULN if the transaminase elevation is due to disease involvement
• Alkaline phosphatase > 5 x ULN without known bony metastases
• Serum bilirubin >1.5 x ULN
• Serum creatinine > 1.5 x ULN or 24-hour creatinine clearance <50 ml/min
• Total serum calcium < LLN or if calcium is below LLN then corrected calcium for serum albumin should be >/= LLN
• Serum potassium < 3.0
• Serum sodium < 130
• Serum albumin <2.5g/dl
• G6PD (glucose-6-phosphate dehydrogenase) deficiency
• Prior exposure to gemcitabine for metastatic disease
• Subjects with prior doxorubicin exposure with a MUGA or ECHO demonstrating LVEF < the lower limit of the institutional normal.
• New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix E)
• History of myocardial infarction or unstable angina within 6 months prior to Day 1
• History of stroke or transient ischemic attack within 6 months prior to Day 1
• Actively receiving insulin or requiring fingerstick glucose monitoring at time of ascorbate infusion
• Patients on warfarin and unable to be substituted to another anticoagulant
• Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
• Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
• Pregnancy (positive pregnancy test) or lactation.
• Women of childbearing potential (WOCBP) who are not willing to use two methods of contraception one of them being a barrier method during the study and for 3 months after last study drug administration
• Patients who are on the following drugs and cannot have a drug substitution: flecainide, methadone, amphetamines, quinidine, and chlorpropamide. High dose ascorbic acid may affect urine acidification and, as a result, may affect clearance rates of these drugs.

Where it is running

• John — Iowa City, Iowa, United States

Full record on ClinicalTrials.gov

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