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Gemcitabine + Ascorbate for Sarcoma

Phase < 1
Recruiting
Led By Mohammed Milhem, MBBS
Research Sponsored by Mohammed Milhem
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.
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

Study 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.Check my eligibility
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.See study design
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 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.
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My brain metastases are treated and stable, with no current need for steroids.
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I have advanced sarcoma, have had chemotherapy, and my tumor is at least 1cm big.
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I am 18 years old or older.
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I can take care of myself and am up and about more than half of my waking hours.
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I can handle a vitamin C infusion without severe side effects.
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My bone cancer has not responded to any treatment, including methotrexate or adriamycin.

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
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determine the 12 weeks progression free survival (PFS 12) at 12 weeks post treatment initiation
Secondary outcome measures
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

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.

Find a Location

Who is running the clinical trial?

Mohammed MilhemLead Sponsor
6 Previous Clinical Trials
104 Total Patients Enrolled
4 Trials studying Sarcoma
77 Patients Enrolled for Sarcoma
University of IowaOTHER
444 Previous Clinical Trials
878,960 Total Patients Enrolled
6 Trials studying Sarcoma
140 Patients Enrolled for Sarcoma
Varun Monga, MDLead Sponsor
6 Previous Clinical Trials
96 Total Patients Enrolled
3 Trials studying Sarcoma
69 Patients Enrolled for Sarcoma

Media Library

Ascorbate (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04634227 — Phase < 1
Sarcoma Research Study Groups: Gemcitabine + High-Dose Ascorbate
Sarcoma Clinical Trial 2023: Ascorbate Highlights & Side Effects. Trial Name: NCT04634227 — Phase < 1
Ascorbate (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04634227 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being actively recruited for this trial?

"Affirmative. Clinicaltrials.gov displays that the clinical trial, which was initially advertised on November 24th 2020, is currently inviting participants to join. The research requires 20 people from a single location."

Answered by AI

Have investigators conducted any other experiments regarding Ascorbate?

"Currently, there are 493 Ascorbate-focused clinical trials with 141 Phase 3 experiments. Adelaide, South Australia houses numerous of these tests; however, other medical centres in a total of 25061 locations around the world are also running investigations into this compound's efficacy."

Answered by AI

What conditions may Ascorbate be administered to alleviate?

"Small cell lung cancer (SCLC), head and neck carcinoma, as well as cervical cancers can all be managed with the help of Ascorbate."

Answered by AI

What is the total capacity of participants for this clinical experiment?

"Affirmative. Data on clinicaltrials.gov shows that this medical trial, which was initially published on November 24th 2020 is actively accepting candidates. The study requires 20 patients who are willing to visit one location for participation."

Answered by AI
~4 spots leftby Aug 2024