30 Participants Needed

Gemcitabine + Ascorbate for Sarcoma

Recruiting at 2 trial locations
JK
JR
Varun Monga, MD profile photo
Mohammed Milhem, MBBS profile photo
Overseen ByMohammed Milhem, MBBS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 6 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you must stop taking your current medications. However, you cannot participate if you are on certain drugs like flecainide, methadone, amphetamines, quinidine, and chlorpropamide, unless you can switch to a different medication. Also, you must not have received chemotherapy or any investigational drug within 2 weeks prior to starting the study drug.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it does mention that patients on certain drugs like warfarin, flecainide, methadone, amphetamines, quinidine, and chlorpropamide may need substitutions. It's best to discuss your specific medications with the trial team.

What safety data exists for Gemcitabine + Ascorbate treatment in sarcoma?

The safety of pharmacological ascorbate combined with gemcitabine has been evaluated in a phase I clinical trial for pancreatic cancer, which aimed to establish safety and tolerability. While this trial was not specific to sarcoma, it provides some insight into the safety profile of the combination treatment. Additionally, ascorbate (vitamin C) has been studied for its potential anticancer effects, though its role remains controversial. The preventive effect of vitamin C on sarcoma induction in mice has been noted, but it did not achieve significant therapeutic levels. Overall, while some safety data exists, specific safety data for Gemcitabine + Ascorbate in sarcoma is limited.12345

Is the combination of Gemcitabine and Ascorbate safe for humans?

A phase I clinical trial found that pharmacological ascorbate (vitamin C) combined with gemcitabine was safe and tolerable in patients with advanced pancreatic cancer, suggesting it may be generally safe for human use.12345

Is Vitamin C a promising treatment for sarcoma?

Yes, Vitamin C, when used in high doses, shows promise as a treatment for sarcoma. It can be easily added to existing treatments and helps kill cancer cells without harming normal cells. This makes it a potentially effective and safe option to improve current sarcoma therapies.23678

What makes the drug Gemcitabine + Ascorbate unique for treating sarcoma?

The combination of Gemcitabine and high-dose intravenous ascorbate (vitamin C) is unique because it leverages ascorbate's ability to produce hydrogen peroxide, which selectively kills cancer cells without harming normal cells. This approach takes advantage of cancer cells' altered oxidative metabolism, potentially enhancing the effectiveness of existing treatments for sarcoma.23678

What data supports the idea that Gemcitabine + Ascorbate for Sarcoma is an effective treatment?

The available research shows that vitamin C (ascorbate) has been studied for its potential in cancer treatment, including sarcoma. In one study, vitamin C was found to prevent the development of sarcomas in mice, although it did not significantly reduce the size or weight of existing tumors. This suggests that vitamin C might help in preventing sarcoma but may not be as effective in treating it once it has developed. There is no direct evidence from the provided research that Gemcitabine + Ascorbate is effective for sarcoma specifically, but vitamin C has shown some preventive effects in animal studies. Additionally, vitamin C combined with another drug, gemcitabine, has been tested for safety in pancreatic cancer, which might suggest potential for use in other cancers, but more specific research would be needed for sarcoma.235910

What data supports the effectiveness of the drug Gemcitabine + Ascorbate for Sarcoma?

Research shows that vitamin C (ascorbate) can prevent the development of certain types of sarcomas in mice, suggesting it might help in preventing tumor growth. Additionally, high doses of ascorbate have shown potential antitumor effects in various cancers, including pancreatic cancer, when used with other treatments like gemcitabine.235910

Who Is on the Research Team?

JR

John Rieth, MD

Principal Investigator

University of Iowa Hospitals & Clinics

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.
I have advanced sarcoma, have had chemotherapy, and my tumor is at least 1cm big.
I have treated brain metastases with no current signs of worsening and don't need steroids.
See 4 more

Exclusion Criteria

Serum bilirubin >1.5 x ULN
Serum sodium < 130
Pregnancy (positive pregnancy test) or lactation.
See 31 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive gemcitabine and high-dose ascorbate. Ascorbate is administered on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. Gemcitabine is administered on Days 1, 8, and 15, after the infusion of ascorbate. Treatment continues for 6 cycles.

24 weeks
Visits on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment. Disease progression is assessed by CT or MRI every 2 cycles.

12 weeks
Every 2 cycles

Extension

Participants whose disease has not progressed and who are tolerating therapy may continue treatment beyond 6 cycles at the discretion of the investigator.

Indefinite, based on disease progression

What Are the Treatments Tested in This Trial?

Interventions

  • Ascorbate
Trial Overview 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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Gemcitabine + High-Dose AscorbateExperimental Treatment1 Intervention

Ascorbate is already approved in United States, European Union, Canada, Japan, China, Switzerland for the following indications:

🇺🇸
Approved in United States as Ascorbic Acid for:
🇪🇺
Approved in European Union as Vitamin C for:
🇨🇦
Approved in Canada as Ascorbate for:
🇯🇵
Approved in Japan as Ascorbic Acid for:
🇨🇳
Approved in China as Vitamin C for:
🇨🇭
Approved in Switzerland as Ascorbate for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials
486
Recruited
934,000+

Mohammed Milhem

Lead Sponsor

Trials
9
Recruited
240+

Varun Monga, MD

Lead Sponsor

Trials
7
Recruited
130+

Mohammed Milhem, MBBS

Collaborator

Trials
2
Recruited
40+

University of Iowa Adolescent and Young Adult (AYA) Cancer Program

Collaborator

Trials
2
Recruited
40+

St. Baldrick's Foundation

Collaborator

Trials
19
Recruited
9,100+

Published Research Related to This Trial

In a phase I clinical trial involving 9 patients with stage IV pancreatic adenocarcinoma, pharmacological ascorbate (vitamin C) combined with gemcitabine was found to be well tolerated, with few adverse effects reported.
The treatment resulted in significantly higher plasma ascorbate levels and a mean survival of 13 months for patients who completed at least two cycles, suggesting potential efficacy that warrants further investigation.
Pharmacological ascorbate with gemcitabine for the control of metastatic and node-positive pancreatic cancer (PACMAN): results from a phase I clinical trial.Welsh, JL., Wagner, BA., van't Erve, TJ., et al.[2022]
A case study suggests that mega ascorbic acid therapy may have been effective in treating reticulum cell sarcoma, indicating potential therapeutic benefits of high-dose vitamin C in cancer treatment.
Despite the initial success with ascorbic acid, the patient later developed papillary thyroid carcinoma, raising questions about the long-term efficacy and role of ascorbic acid in cancer prevention and body resistance.
Development of a papillary thyroid carcinoma in a patient while on high dosage ascorbic acid therapy.Campbell, A.[2019]
Vitamin C (VC) significantly prevented the induction of malignant sarcomas in mice when administered in drinking water, demonstrating its potential as a prophylactic treatment against cancer.
However, VC did not significantly reduce the size or weight of existing tumors, indicating that while it may help prevent cancer development, it is not effective as a therapeutic intervention once tumors have formed.
Preventive effect of vitamin C (L-ascorbic acid) on methylcholanthrene-induced soft tissue sarcomas in mice.Abdel-Galil, AM.[2018]

Citations

Pharmacological ascorbate with gemcitabine for the control of metastatic and node-positive pancreatic cancer (PACMAN): results from a phase I clinical trial. [2022]
Development of a papillary thyroid carcinoma in a patient while on high dosage ascorbic acid therapy. [2019]
Preventive effect of vitamin C (L-ascorbic acid) on methylcholanthrene-induced soft tissue sarcomas in mice. [2018]
The prospects of vitamin C in cancer therapy. [2021]
Ascorbate induces autophagy in pancreatic cancer. [2021]
Relationship between ascorbyl radical intensity and apoptosis-inducing activity. [2017]
Regulation of collagen synthesis in human dermal fibroblasts by the sodium and magnesium salts of ascorbyl-2-phosphate. [2019]
Palmitoyl ascorbate liposomes and free ascorbic acid: comparison of anticancer therapeutic effects upon parenteral administration. [2021]
Redox active metals and H2O2 mediate the increased efficacy of pharmacological ascorbate in combination with gemcitabine or radiation in pre-clinical sarcoma models. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
High-dose parenteral ascorbate enhanced chemosensitivity of ovarian cancer and reduced toxicity of chemotherapy. [2015]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security