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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)

Must not have

Subjects with rapidly progressing central nervous system (CNS) disease with associated neurological deterioration

Subjects who have contraindications to carboplatin, cyclophosphamide, etoposide phosphate, or sodium thiosulfate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My brain condition is getting worse quickly.

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I cannot take certain chemotherapy drugs due to adverse reactions.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~6120

Cyclophosphamide

2010

Completed Phase 4

~2310