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Alkylating agents

Chemotherapy +/− Sodium Thiosulfate for Brain Tumor

Phase 2

Waitlist Available

Led By Edward A Neuwelt

Research Sponsored by OHSU Knight Cancer Institute

Eligibility Criteria Checklist

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

Must have

Subjects with histologically confirmed high-grade glioma

Performance status (Eastern Cooperative Oncology Group [ECOG]) must be less than or equal to 2 (Karnofsky greater than or equal to 50)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

Study Summary

This trial studies how well giving chemotherapy with or without sodium thiosulfate works in preventing low platelet count while treating patients with brain tumors.

Who is the study for?

This trial is for patients with high-grade malignant brain tumors who've had a break from prior treatments. They must have stable vital signs, agree to use birth control if applicable, and not be pregnant or breastfeeding. Those with rapid disease progression or serious unrelated health issues are excluded.Check my eligibility

What is being tested?

The study tests whether adding sodium thiosulfate to standard chemotherapy (carboplatin, cyclophosphamide, etoposide phosphate) prevents low platelet counts in brain tumor treatment. Patients are randomly assigned to receive either the chemo alone or with sodium thiosulfate.See study design

What are the potential side effects?

Chemotherapy may cause nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts, and potential organ damage. Sodium thiosulfate's role is being studied for its ability to protect against these side effects.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with a high-grade brain tumor.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Erythrocyte counts

Granulocyte count

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (combination chemotherapy, sodium thiosulfate)Experimental Treatment5 Interventions

Patients receive cyclophosphamide IV, etoposide phosphate IV, and carboplatin IA as in Arm I. Patients also receive sodium thiosulfate IV over 15 minutes 4 and 8 hours later. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Group II: Arm I (combination chemotherapy)Experimental Treatment4 Interventions

Patients receive cyclophosphamide IV, etoposide phosphate IV, and carboplatin IA over 10 minutes. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Carboplatin

2014

Completed Phase 3

~6670

Cyclophosphamide

1995

Completed Phase 3

~3780

Etoposide Phosphate

2011

Completed Phase 2

~160

Sodium Thiosulfate

2014

Completed Phase 3

~90

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Oregon Health and Science UniversityOTHER

973 Previous Clinical Trials

6,845,981 Total Patients Enrolled

OHSU Knight Cancer InstituteLead Sponsor

230 Previous Clinical Trials

2,090,678 Total Patients Enrolled

Edward A NeuweltPrincipal InvestigatorOHSU Knight Cancer Institute

5 Previous Clinical Trials

160 Total Patients Enrolled

Media Library

Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00075387 — Phase 2

Malignant Glioma Research Study Groups: Arm I (combination chemotherapy), Arm II (combination chemotherapy, sodium thiosulfate)

Malignant Glioma Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT00075387 — Phase 2

Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00075387 — Phase 2

Frequently Asked Questions

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

How many participants are partaking in this research experiment?

"Unfortunately, no patients are being accepted for this trial anymore. It was first posted on March 7th 2003 and last modified April 29th 2022. If you're interested in alternative studies, 355 trials recruiting participants with glioma and 1539 clinical trials actively looking for Carboplatin candidates are available at the moment."

Answered by AI

Does this experiment accept participants who are older than twenty-five?

"The criteria for enrolment into this trial specifies that applicants should be aged between 18 and 75. 482 studies have been conducted on those below the age of majority, while 1529 clinical trials focus on patients over 65."

Answered by AI

How has Carboplatin been evaluated for safety in humans?

"Prior clinical data suggests Carboplatin is relatively safe, resulting in the compound receiving a score of 2. At this stage there is no evidence to suggest it has efficacy properties."

Answered by AI

Which patients may participate in this experimental research?

"To be eligible for this glioma trial, prospective participants must meet the age criteria of between 18 and 75 years old. A total of 48 individuals will be inducted into the program."

Answered by AI

Are there any precedents for Carboplatin to be tested in a clinical environment?

"Presently, 1539 Carboplatin studies are ongoing globally with 369 in the final stage of research. Although Philadelphia is a hub for these trials, there exist 70125 sites spread across the globe conducting investigations into this therapy."

Answered by AI

Are there any slots still available to enrollees for this research study?

"At this moment in time, clinicaltrials.gov does not indicate that any additional participants are required for the study posted on 3/7/2003 and last updated 4/29/2022. Nevertheless, there exists an abundance of other medical trials actively recruiting volunteers at present."

Answered by AI

What medicinal purpose is Carboplatin typically employed for?

"Primarily employed to treat Merkel cell cancer, Carboplatin is also capable of treating other malignancies such as leukemia, prostate cancer and providing initial treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination Chemotherapy With or Without Sodium Thiosulfate in Preventing Low Platelet Count While Treating Patients With Malignant Brain Tumors

Edward Neuwelt 2003. "Combination Chemotherapy With or Without Sodium Thiosulfate in Preventing Low Platelet Count While Treating Patients With Malignant Brain Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00075387.

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