CLINICAL TRIAL

Ascorbate for Sarcoma

Recruiting · 18+ · All Sexes · Iowa City, IA

This study is evaluating whether a drug called pembrolizumab may help treat sarcoma.

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About the trial for Sarcoma

Eligible Conditions
Sarcoma, Bone · Sarcoma · Soft Tissue Sarcoma (STS) · Unresectable Soft Tissue Sarcoma · Osteosarcoma · Metastatic Bone Tumor

Treatment Groups

This trial involves 2 different treatments. Ascorbate is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Ascorbate
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Male or female patients aged ≥ 18 years old
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.
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.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Every 2 months for first 6 months, then every 3 months up to 2 years post treatment
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Every 2 months for first 6 months, then every 3 months up to 2 years post treatment.
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Ascorbate will improve 1 primary outcome and 3 secondary outcomes in patients with Sarcoma. Measurement will happen over the course of 12 weeks post-treatment.

Determine the tumor response as per RECIST 1.1 criteria
12 WEEKS POST-TREATMENT
Tumor response will be defined using the RECIST 1.1 guidelines as below Complete response is the disappearance of all target lesions; Any pathological lymph nodes ( whether target or Non-target) must have reduction in short axis to <10mm. Partial response is a 30% decrease in the sum of the longest dimension (LD) of target lesions, relative to baseline measurement; Progressive disease is an increase of 20% or more in the sum of the LD of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm.Or appearance of a new malignant lesion. Stable disease is a decrease in tumor size of less than 30% or increase of less than 20%.
Determine the 12 weeks progression free survival (PFS 12) at 12 weeks post treatment initiation
12 WEEKS POST-TREATMENT
The primary endpoint of interest is PFS12 defined as the proportion of patients without progressive disease per RECIST 1.1 at 12 weeks after treatment initiation. A sample size of 10 evaluable patients per disease cohort (soft tissue and bone) will allow for the estimation of PFS12 per the 90% exact confidence intervals as follows: PFS12 Exact 90% confidence interval: 1/10 10% (1-39%); 2/10 20% (4-51%); 3/10 30% (9-61%); 4/10 40% (15-70%); 5/10 50% (22-78%); 6/10 60% (30-85%); 7/10 70% (39-91%); 8/10 80% (49-96%); 9/10 90% (61-99%);
Incidence of Adverse Events (AE) Per CTCAE 4.03
UP TO 30 DAYS AFTER COMPLETION OF STUDY TREATMENT
Evaluate the safety and tolerability of this regimen by the incidence of AEs per CTCAE 4.03
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
EVERY 2 MONTHS FOR FIRST 6 MONTHS, THEN EVERY 3 MONTHS UP TO 2 YEARS POST TREATMENT
Time from start of therapy (day 1, cycle 1) to death.

Patient Q & A Section

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

How many people get sarcoma a year in the United States?

There is approximately 1.3 million new cases of leukaemia and 1.4 million new cases of soft-tissue sarcoma per year in the United States. Soft-tissue sarcomas are the most common primary cancer in patients under 30 years of age.

Anonymous Patient Answer

What is sarcoma?

A sarcoma is a malignancy that arises in the connective tissues. The most common form is soft tissue sarcoma and the less common forms include mesenchymal tumors that affect the limbs. Sarcomas can be categorized into soft tissue sarcomas and germ cell tumors which originate from the gonads. The most common subtype of soft tissue sarcoma is liposarcoma. Mesenchymal tumors of the soft tissue that affect the limbs and muscles include Ewing sarcoma, GIST, and synovial sarcoma.

Anonymous Patient Answer

What are common treatments for sarcoma?

Most sarcomiogenic tumor cells are sensitive to chemotherapy. Radiation can be used to shrink solid tumors. Local chemotherapy may be of limited efficacy in sarcomas. Local chemotherapy may have value with inoperable or incurable sarcomas. Targeted therapy is available now in the United States for metastatic sarcoma. Targeted treatment includes the use of imatinib in the treatment of gastrointestinal and pancreatic cancers.\n

Anonymous Patient Answer

What are the signs of sarcoma?

There is no single sign of sarcoma; therefore, a thorough history and physical examination to look for any potentially visible sign of an tumour is recommended. The physical examination must be supplemented with an appropriate imaging review. When an tumour seems potentially visible, a biopsy is often indicated to exclude a sarcoma.

Anonymous Patient Answer

Can sarcoma be cured?

Current research in sarcoma suggests that it might be possible to devise effective means of eradicating cancer cells with the use of immune-mediated cytotoxic agents.

Anonymous Patient Answer

What are the latest developments in ascorbate for therapeutic use?

Currently ascorbic acid has not been shown to be an effective treatment. A possible explanation for this discrepancy is that people with a severe disease, such as that of chronic neutropenia have little in their diets that stimulates ascorbic acid synthesis as they lack neutrophils. To date, there have been four published studies on ascorbic acid and neoplastic conditions; three showed a positive effect while one showed none. This indicates that ascorbic acid supplementation may be unnecessary in those patients already receiving ascorbic acid.

Anonymous Patient Answer

Have there been any new discoveries for treating sarcoma?

The last five years have ushered in a new era in which new drugs and therapeutics are being developed, and they may eventually become more easily accessible, so we may one day be able to offer treatment for sarcoma. But as Dr. Segev states, it will be “one long, hard road,” until then - until it gets a little bit better. Still, there are new developments in the area from the discovery of new drugs, like cilengitide, as well as biologics, like cetuximab. It may not necessarily mean that the next breakthrough is coming soon, but it can signify that sarcoma will get better treatment.

Anonymous Patient Answer

What is the average age someone gets sarcoma?

The average age the patients diagnosed was 41 years. Patients diagnosed earlier than 39 years of age are more likely to have a more aggressive form of the disease. If sarcoma is found on a patient who's <40 years of age and has no family history, a more aggressive type is more likely.

Anonymous Patient Answer

Have there been other clinical trials involving ascorbate?

No placebo controlled trials exist to assess its long-term effects in children with cancer. Studies in rats have shown the efficacy of oral ascorbyl phosphate. There is no indication of harmful health effects of ascorbate in children with cancer and their parents. The most important point is the requirement for dose adjustment of ascorbate and its potential role as an adjuvant treatment with standard treatments. Further investigations are needed.

Anonymous Patient Answer

What is the survival rate for sarcoma?

In the majority of sarcomas, the tumor can be eliminated surgically and hence the prognosis is excellent except for a few sarcomas like Ewing's sarcoma and soft tissue sarcoma which are often associated with a higher risk of relapse and hence prognosis is more guarded.\n\nSarcoma is one of the ten most common cancers worldwide. Sarcoma is the second most common cancer in the UK.

Anonymous Patient Answer
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