CLINICAL TRIAL

Sodium Thiosulfate for Glioma

Waitlist Available · 18+ · All Sexes · Portland, OR

This study is evaluating whether a combination of chemotherapy and sodium thiosulfate is more effective than chemotherapy alone in preventing low platelet counts in patients with malignant brain tumors.

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About the trial for Glioma

Eligible Conditions
Glioma · Gliomas, Malignant

Treatment Groups

This trial involves 2 different treatments. Sodium Thiosulfate is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Carboplatin
DRUG
+
Cyclophosphamide
DRUG
+
Quality-of-Life Assessment
OTHER
+
Etoposide Phosphate
DRUG
Experimental Group 2
Sodium Thiosulfate
DRUG
+
Carboplatin
DRUG
+
Cyclophosphamide
DRUG
+
Quality-of-Life Assessment
OTHER
+
Etoposide Phosphate
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Thiosulfuric acid
FDA approved
Carboplatin
FDA approved
Cyclophosphamide
FDA approved
Etoposide
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
A white blood cell count of more than 2.5 x 10^3/mm^3 is considered high. show original
Subjects may have had prior focal or systemic radiation or chemotherapy; at least 14 days must have elapsed since radiation treatment and 28 days since prior chemotherapy show original
The patient's performance status must be less than or equal to 2 and their Karnofsky score must be greater than or equal to 50. show original
A blood test result shows that the absolute granulocyte count is 1.2 x 10^3/mm^3 or greater. show original
The subject or legal guardian must sign a written informed consent in accordance with the institutional guidelines. show original
Subjects with histologically confirmed high-grade glioma are eligible; diagnosis of high-grade glioma will be made on the basis of needle biopsy, open biopsy, or surgical resection
Platelets >= 100 x 10^3/mm^3
Creatinine < 1.8
Bilirubin < 2.0
(ULN) The level of aspartate aminotransferase (AST), alanine aminotransferase (ALT), serum glutamic oxaloacetic transaminase (SGOT), and serum glutamate pyruvate transaminase (SGPT) in your serum must be lower than 2.5 times the institutional upper limit of normal (ULN) for you to be eligible for the study. show original
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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: Up to 10 years
Screening: ~3 weeks
Treatment: Varies
Reporting: Up to 10 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Up to 10 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- 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 Sodium Thiosulfate will improve 1 primary outcome and 8 secondary outcomes in patients with Glioma. Measurement will happen over the course of Up to 60 days after completion of study treatment.

Quality of life assessed by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and Quality of Life Questionnaire-Brain Module-20
UP TO 60 DAYS AFTER COMPLETION OF STUDY TREATMENT
Summarized by means over time and by plots of values over time for each patient. Quality of life data comparisons between the groups will use repeated measure analysis of covariance (baseline assessment as the covariate).
UP TO 60 DAYS AFTER COMPLETION OF STUDY TREATMENT
Erythrocyte counts
UP TO 30 DAYS AFTER COMPLETION OF STUDY TREATMENT
The Pearson chi-square test will be the primary test to compare rates.
UP TO 30 DAYS AFTER COMPLETION OF STUDY TREATMENT
Granulocyte count
UP TO 30 DAYS AFTER COMPLETION OF STUDY TREATMENT
The Pearson chi-square test will be the primary test to compare rates.
UP TO 30 DAYS AFTER COMPLETION OF STUDY TREATMENT
Change in hearing levels, if any, at the higher frequencies in the standard testing range (4000 and 8000 Hz), and at higher frequencies above standard testing (9000 to 16000 Hz) based on American Speech-Language-Hearing Association criteria
BASELINE UP TO 30 DAYS AFTER COMPLETION OF STUDY TREATMENT
Descriptive summaries for hearing levels will include means by time and plots of hearing levels by patient over time. The analyses for hearing will include both a time to oto-toxicity (based on American Speech-Language-Hearing Association criteria) comparison using the log rank test and a repeated measure analysis of covariance of the actual hearing levels (with baseline hearing levels as the covariate). Separate analyses will be performed for each hearing frequency with no adjustment for multiple comparisons (as these analyses are descriptive in nature).
BASELINE UP TO 30 DAYS AFTER COMPLETION OF STUDY TREATMENT
Number of dose reductions and transfusions due to platelet toxicity
UP TO 30 DAYS AFTER COMPLETION OF STUDY TREATMENT
Analyzed using generalized estimating equations and/or a generalized mixed model (for repeated measures analysis of variance) and the third using mixed model repeated measures analysis of variance model.
UP TO 30 DAYS AFTER COMPLETION OF STUDY TREATMENT
Rate of platelet toxicities (i.e. platelet count less than 20,000), graded according to the National Cancer Institute Common Toxicity Criteria version 3.0
UP TO 4 WEEKS AFTER COMPLETION OF STUDY TREATMENT
The Pearson chi-square test will be the primary test to compare rates.
UP TO 4 WEEKS AFTER COMPLETION OF STUDY TREATMENT
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Who is running the study

Principal Investigator
E. N.
Edward Neuwelt, Principal Investigator
OHSU Knight Cancer Institute

Patient Q & A Section

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

What causes glioma?

Exposure to asbestos and drinking large amounts of alcohol are associated with increased risk of glioma. Poor immune system function and exposure to mutagenic chemicals appear to be major factors in the development of this disabling and rarely curable brain cancer.

Anonymous Patient Answer

What are the signs of glioma?

The most common sign of a malignant brain tumour is headaches, often with a sudden onset. Other signs include signs of increased intracranial pressure, including vomiting, ocular abnormalities and papilledema. Tumour markers, such as alpha-fetoprotein and neurofilament light, may be useful. Neurological examination often reveals signs of a new or worsening tumour. On MRI, the most common lesion in a glioma is a ring-enhancing ring, which also tends to cause increased intracranial pressure, as can the ring-enhancing boundary around an anaplastic astrocytoma.

Anonymous Patient Answer

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

Approximately 2,400 people per year in the United States are diagnosed with glioma. This makes up 0.3% of people in the US. Although glioma has a low annual incidence of diagnosis in the United States at 0.3% of all cancers, mortality is 0.4%, suggesting that glioma may still be a significant cause of morbidity and mortality in the United States.

Anonymous Patient Answer

Can glioma be cured?

The treatment of glioma has shifted from the traditional surgical management to a multimodality approach, with increased use of adjuvant or neoadjuvant treatments. The extent of surgical resection is only one of the factors in deciding how to plan and deliver therapy. The extent of surgery may also be performed in conjunction with additional concurrent or adjuvant treatments to induce a dramatic, rapid, and durable clinical response, which helps optimize neurologic and functional outcomes.

Anonymous Patient Answer

What are common treatments for glioma?

Glioma treatments can be divided into surgery, radiotherapy, chemotherapy, and targeted therapies. Surgical removal is not always curative, but the extent of resection can be increased by radiotherapy and chemotherapy, and also improved with targeted therapies. As an important component of cancer care, surgeons should take time to learn and understand the principles of cancer research and treatment.

Anonymous Patient Answer

What is glioma?

Gliomas are often misdiagnosed and misclassified into noncompliant tumors, due in part to the ambiguous nature of the radiologic images that lead to their misinterpretation. A review of diagnostic criteria for diagnosing and treating gliomas is warranted.

Anonymous Patient Answer

Is sodium thiosulfate typically used in combination with any other treatments?

The authors nsay only low-dose sodium thiosulphate is associated with increased efficacy. The combination of low-dose sodium thiosulphate with nthe adjuvant gemcitabine treatment, a chemotherapeutic drug, produces a statistically significant increase in the median survival of rats with low-grade astrocytoma"

"Lehmannia granifer\n\nLehmannia granifer is a species of air-breathing land snail, a terrestrial pulmonate gastropod mollusk in the family Streptaxidae.

Anonymous Patient Answer

Who should consider clinical trials for glioma?

This analysis suggests that high-risk patients are the most likely to benefit from clinical trial enrollment. However, a reasonable number of patients must be included in clinical trials before they are considered for inclusion in high-risk patient treatment protocols.

Anonymous Patient Answer

Does sodium thiosulfate improve quality of life for those with glioma?

Although thiosulfate does not influence the average overall survival time of people with malignant glioma, it has a beneficial effect on QoL during the initial phases of treatment. This effect was not observed at 1 or 2 years after treatment cessation.

Anonymous Patient Answer

What is the primary cause of glioma?

Most gliomas develop from normal brain tissue. A primary cause of glioma is not always found in patients. Patients who have a family history of glioma do not have a primary cause of glioma. About 20 percent of pediatric patients with glioma have hereditary cancer syndromes with germline mutations in one of about 15 genes, with mutations in the p16 gene being the most common. About 40 percent of adult patients have one or more hereditary cancers. If cancer in an individual is known to be hereditary, it is generally thought that a germline mutation in one of these genes is responsible for susceptibility to that kind of cancer.

Anonymous Patient Answer

What are the latest developments in sodium thiosulfate for therapeutic use?

The most recent developments included the discovery of several novel agents with pharmacological activity, and many studies of the mechanisms of action of sodium thiosulfate in the CNS, including its effects on glutamate, ammonia and glycine. In addition, a new sodium thiosulfate-labeled compound for clinical trials was developed at DCE-CRC.

Anonymous Patient Answer

Does glioma run in families?

There is strong evidence for an inherited association of brain tumours. This association may arise as a consequence of the genetics of the tumour cell itself, the patient's genetic background, which may influence tumour behaviour, or may be modifiable in the same way that common disease does. Future large, prospective studies with genetic analysis should validate this finding.

Anonymous Patient Answer
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