Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate With or Without Sodium Thiosulfate in Treating Patients With High-Grade Glioma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Supportive care, Treatment	Active	18 to 75	NCI	OHSU-7328 OHSU-922, OHSU-ONC-02059-L, NCT00075387, CASE-CCF-6385

Objectives

Primary

1. Determine the effect of delayed administration of high-dose sodium thiosulfate on platelet counts in patients with high-grade glioma undergoing treatment with intra-arterial carboplatin, cyclophosphamide, and etoposide or etoposide phosphate.

Secondary

1. Determine the effect of delayed administration of high-dose sodium thiosulfate on granulocyte and erythrocyte counts in patients treated with this chemotherapy regimen.
2. Determine the tumor response in patients treated with this chemotherapy regimen with or without delayed high-dose sodium thiosulfate.
3. Determine hearing changes at higher frequencies in the standard testing range (i.e., 4,000 and 8,000 Hz) and at higher frequencies above standard testing range (i.e., 9,000 and 16,000 Hz) in patients treated with these regimens.
4. Determine the quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically confirmed high-grade glioma by needle biopsy, open biopsy, or surgical resection



• No rapidly progressing CNS disease with associated neurological deterioration

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• At least 4 weeks since prior chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• At least 2 weeks since prior focal or systemic radiotherapy

Surgery

• Prior surgery or biopsy allowed

Patient Characteristics:

Age

• 18 to 75

Performance status

• ECOG 0-2

  OR

• Karnofsky 50-100%

Life expectancy

• Not specified

Hematopoietic

• WBC at least 2,500/mm³
• Absolute granulocyte count at least 1,200/mm³
• Platelet count at least 100,000/mm³

Hepatic

• Bilirubin less than 2.0 mg/dL
• SGOT/SGPT less than 2.5 times upper limit of normal

Renal

• Creatinine less than 1.8 mg/dL

Cardiovascular

• Adequate cardiovascular function to tolerate monitored anesthesia

Pulmonary

• Adequate pulmonary function to tolerate monitored anesthesia

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception for at least 2 months before and during study participation
• No uncontrolled clinically significant confounding medical condition within the past 30 days
• No contraindication to the study medications

Expected Enrollment

A total of 60 patients (30 per treatment arm) will be accrued for this study.

Outcomes

Protection against severe thrombocytopenia as measured by the number of patients requiring platelet transfusions based on labs obtained weekly during treatment

Tumor response positive or negative for sodium thiosulfate (STS) as measured by radiographic response from the first day of treatment until tumor progression
Effect of STS on granulocytes and erythrocytes as measured by complete blood count lab values obtained weekly during treatment
Hearing changes assessed by audiology hearing test every 2 months during treatment
Quality of life assessed by EORTC QOL before treatment, at 6 months, and at completion of treatment

Outline

This is a randomized, multicenter study. Patients are stratified according to histology type (glioblastoma multiforme vs other high-grade glioma). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive cyclophosphamide IV over 10 minutes, etoposide phosphate IV over 10 minutes (or etoposide IV), and carboplatin intra-arterially over 10 minutes on day 1. Beginning on day 3, patients receive filgrastim (G-CSF) subcutaneously once daily for 7-10 days until blood counts recover.



• Arm II: Patients receive cyclophosphamide, etoposide phosphate or etoposide, carboplatin, and G-CSF as in arm I. At 4 and 8 hours after carboplatin administration, patients receive high-dose sodium thiosulfate IV over 15 minutes.

In both arms, treatment repeats every 4 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every 6 months during study treatment, and then within 30 days after the final study treatment.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Knight Cancer Institute at Oregon Health and Science University

Edward Neuwelt, MD, Principal investigator		Ph: 503-494-5626; 800-494-1234 Email: Neuwelte@ohsu.edu

U.S.A.
Ohio
	Cincinnati
	Good Samaritan Hospital Cancer Treatment Center
		Robert Albright, MD	Ph:  513-936-5370
			Email: ralbright@ohcmail.com
Oregon
	Portland
	Knight Cancer Institute at Oregon Health and Science University
		Clinical Trials Office - Knight Cancer Institute at Oregon Health and Science University	Ph:  503-494-1080
			Email: trials@ohsu.edu

Registry Information
Official Title		Phase II Clinical Trial Of Patients With High-Grade Glioma Treated With Intra-Arterial Carboplatin-Based Chemotherapy, Randomized To Treatment With Or Without Delayed Intravenous Sodium Thiosulfate As A Potential Chemoprotectant Against Severe Thrombocytopenia
Trial Start Date		2003-03-07
Trial Completion Date		2010-01-01 (estimated)
Registered in ClinicalTrials.gov		NCT00075387
Date Submitted to PDQ		2003-11-11
Information Last Verified		2009-06-24
NCI Grant/Contract Number		CA69533

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