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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


Phase 2
18 Years
75 Years
Open (Enrolling)
Both
Brain and Central Nervous System Tumors, Thrombocytopenia

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Trial Information

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


OBJECTIVES:

Primary

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

Secondary

- Determine the effect of delayed administration of high-dose sodium thiosulfate on
granulocyte and erythrocyte counts in patients treated with this chemotherapy regimen.

- Determine the tumor response in patients treated with this chemotherapy regimen with or
without delayed high-dose sodium thiosulfate.

- 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.

- Determine the quality of life of patients treated with these regimens.

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 1: no STS or Arm 2: STS).

- 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. Alternatively, one dose of Neulasta
(Pegfilgrastim) instead of G-CSF 24-72 hrs after chemotherapy.

- Arm II: Patients receive cyclophosphamide, etoposide phosphate or etoposide and
carboplatin as in arm 1. At 4 and 8 hours after carboplatin administration, patients
receive high-dose sodium thiosulfate IV over 15 minutes. Then, G-CSF as in arm 1.
Alternatively, one dose of Neulasta (Pegfilgrastim) instead of G-CSF 24-72 hrs after
chemotherapy.

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.

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

Inclusion Criteria


INCLUSION CRITERIA:

- Signed written informed consent form in accordance with institutional guidelines

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

- Age 18 to 75 years

- Performance status ECOG 0-2 OR Karnofsky 50-100%

- WBC at least 2,500/mm^3

- Absolute granulocyte count at least 1,200/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin less than 2.0 mg/dL

- SGOT/SGPT less than 2.5 times upper limit of normal

- Creatinine less than 1.8 mg/dL

- Fertile patients must use effective contraception for at least 2 months before and
during study participation

EXCLUSION CRITERIA:

- Rapidly progressing CNS disease with associated neurological deterioration

- Uncontrolled clinically significant confounding medical condition within the past 30
days such as congestive heart failure

- Pregnant or lactating, or positive serum HCG.

- Contraindications to the study medications

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Up to 12 months

Safety Issue:

No

Principal Investigator

Edward A. Neuwelt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

OHSU-922

NCT ID:

NCT00075387

Start Date:

March 2003

Completion Date:

December 2014

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Thrombocytopenia
  • thrombocytopenia
  • adult glioblastoma
  • recurrent adult brain tumor
  • adult anaplastic astrocytoma
  • adult mixed glioma
  • Glioma
  • Nervous System Neoplasms
  • Thrombocytopenia
  • Central Nervous System Neoplasms

Name

Location

Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098
University of MinnesotaMinneapolis, Minnesota  55455
Good Samaritan Hospital Cancer Treatment Center, Hatton InstituteCincinnati, Ohio  45220