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Gemcitabine + Ascorbate for Sarcoma

Phase < 1

Recruiting

Led By John Rieth, MD

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG Performance Status of ≤ 2

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.

Must not have

Actively receiving insulin or requiring fingerstick glucose monitoring at time of ascorbate infusion

G6PD (glucose-6-phosphate dehydrogenase) deficiency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up every 2 months for first 6 months, then every 3 months up to 2 years post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial will enroll patients with metastatic sarcoma who have not responded to prior treatment.

Who is the study for?

Adults aged 18+ with advanced, inoperable or metastatic soft tissue or bone sarcoma (excluding GIST and Kaposi's) who have tried at least one chemotherapy regimen. Participants must be physically capable of tolerating a high-dose vitamin C infusion and not have certain heart conditions, uncontrolled medical issues, recent major surgeries, HIV, or severe kidney stones.

What is being tested?

The trial is testing the effectiveness of combining Gemcitabine (a chemotherapy drug) with Ascorbate (high-dose vitamin C) to treat various types of sarcomas. The study aims to see if this combination can help control the disease better than existing treatments.

What are the potential side effects?

Potential side effects may include typical reactions to infusions such as discomfort at the injection site, fatigue, nausea; possible impact on blood sugar levels for diabetics; increased risk of kidney stones; and potential interactions with certain medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself but might not be able to do heavy physical work.

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I have advanced sarcoma, have had chemotherapy, and my tumor is at least 1cm big.

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I have treated brain metastases with no current signs of worsening and don't need steroids.

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My cancer has worsened after the last treatment or was already advanced when first diagnosed.

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My bone sarcoma has not responded to any effective treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I use insulin or check my blood sugar levels during ascorbate infusions.

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I have G6PD deficiency.

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My heart condition limits my physical activity.

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My kidney function is below normal levels.

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I have been treated with gemcitabine for cancer that has spread.

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My heart function is below normal after receiving doxorubicin.

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I am on warfarin and cannot switch to another blood thinner.

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I do not have any severe or uncontrolled medical conditions.

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My alkaline phosphatase levels are high, but I don't have bone metastases.

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I haven't taken chemotherapy or experimental drugs in the last 2 weeks and have recovered from any side effects.

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I am HIV positive but haven't been required to test for it at baseline.

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I have not had a stroke or mini-stroke in the last 6 months.

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I have had more than one painful kidney stone or visible stone on a CT scan in the last 6 months.

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I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 2 months for first 6 months, then every 3 months up to 2 years post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~every 2 months for first 6 months, then every 3 months up to 2 years post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and every 2 months for first 6 months, then every 3 months up to 2 years post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Determine the 12 weeks progression free survival (PFS 12) at 12 weeks post treatment initiation

Secondary study objectives

Assess overall survival of patients with unresectable or metastatic soft tissue and bone sarcoma treated with high dose ascorbate when administered intravenously concurrently with gemcitabine

Neoplasms

Incidence of Adverse Events (AE) Per CTCAE 4.03

Side effects data

From 2024 Phase 1 & 2 trial • 25 Patients • NCT03508726

67%

Nausea

67%

Lymphocyte count decreased

50%

Investigations - Other, specify

50%

Hypertension

50%

Fatigue

33%

Dermatitis radiation

33%

Alanine aminotransferase increased

33%

Dry mouth

33%

Anemia

33%

Neutrophil count decreased

33%

White blood cell decreased

33%

Headache

17%

Blood bilirubin increased

17%

Hyperglycemia

17%

Abdominal pain

17%

Hypoalbuminemia

17%

Pain

17%

Rash maculo-papular

17%

Skin and subcutaneous tissue disorders - Other, specify

17%

Tumor pain

17%

Infections and infestations - Other, specify

17%

Aspartate aminotransferase increased

17%

Thrush

17%

Urinary tract infection

17%

Alkaline phosphatase increased

17%

Gastrointestinal disorders - Other, specify

17%

Vomiting

17%

Colitis

17%

Rectal pain

17%

Diarrhea

17%

Hemorrhoids

17%

Platelet count decreased

17%

Anorexia

17%

Presyncope

17%

Dysuria

17%

Cough

17%

Dyspnea

17%

Hyperhidrosis

17%

Pruritus

100%

80%

60%

40%

20%

Study treatment Arm

Phase I: Ascorbate 75 mg IV Infusion

Phase II: Ascorbate 75 mg IV Infusion

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Gemcitabine + High-Dose AscorbateExperimental Treatment1 Intervention

Ascorabte is administered 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 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ascorbate

2019

Completed Phase 2

~30

0 / 19Eligibility criteria met