Full Text View
Tabular View
No Study Results Posted
Related Studies
Carboplatin, Cyclophosphamide, and Etoposide or Etoposide Phosphate With or Without Sodium Thiosulfate in Treating Patients With High-Grade Glioma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), June 2009
First Received: January 9, 2004   Last Updated: June 25, 2009   History of Changes
Sponsors and Collaborators: Oregon Health and Science University
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00075387
  Purpose

RATIONALE: Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, etoposide, and etoposide phosphate, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells. Chemoprotective drugs, such as sodium thiosulfate, may protect blood platelets from the side effects of chemotherapy.

PURPOSE: This randomized phase II trial is studying combination chemotherapy and sodium thiosulfate to see how well they work compared to combination chemotherapy alone in treating patients with high-grade glioma.


Condition Intervention Phase
Brain and Central Nervous System Tumors
Thrombocytopenia
 Drug: carboplatin
Drug: cyclophosphamide
Drug: etoposide
Drug: etoposide phosphate
Drug: sodium thiosulfate
 Phase II

Study Type: Interventional
Study Design: Supportive Care, Randomized, Active Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Cyclophosphamide Sodium thiosulfate Etoposide Carboplatin Etoposide phosphate Sodium hyposulfite
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Protection against severe thrombocytopenia as measured by the number of patients requiring platelet transfusions based on labs obtained weekly during treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor response positive or negative for sodium thiosulfate (STS) as measured by radiographic response from the first day of treatment until tumor progression [ Designated as safety issue: No ]
  • Effect of STS on granulocytes and erythrocytes as measured by complete blood count lab values obtained weekly during treatment [ Designated as safety issue: No ]
  • Hearing changes assessed by audiology hearing test every 2 months during treatment [ Designated as safety issue: No ]
  • Quality of life assessed by EORTC QOL before treatment, at 6 months, and at completion of treatment [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2003
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm I: Active Comparator
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.
Drug: carboplatin
Etoposide, carboplatin, and cyclophosphamide given IV; etoposide phosphate given intrarterially
Drug: cyclophosphamide
Etoposide, carboplatin, and cyclophosphamide given IV; etoposide phosphate given intrarterially
Drug: etoposide
Etoposide, carboplatin, and cyclophosphamide given IV; etoposide phosphate given intrarterially
Drug: etoposide phosphate
Etoposide, carboplatin, and cyclophosphamide given IV; etoposide phosphate given intrarterially
Arm II: Experimental
Patients receive cyclophosphamide, etoposide phosphate or etoposide, and carboplatin as in arm I. At 4 and 8 hours after carboplatin administration, patients receive high-dose sodium thiosulfate IV over 15 minutes.
Drug: carboplatin
Etoposide, carboplatin, and cyclophosphamide given IV; etoposide phosphate given intrarterially
Drug: cyclophosphamide
Etoposide, carboplatin, and cyclophosphamide given IV; etoposide phosphate given intrarterially
Drug: etoposide
Etoposide, carboplatin, and cyclophosphamide given IV; etoposide phosphate given intrarterially
Drug: etoposide phosphate
Etoposide, carboplatin, and cyclophosphamide given IV; etoposide phosphate given intrarterially
Drug: sodium thiosulfate
Given IV

Detailed Description:

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 intra-arterial 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 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.

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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/mm^3
  • Absolute granulocyte count at least 1,200/mm^3
  • Platelet count at least 100,000/mm^3

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075387

Locations
United States, Ohio
Good Samaritan Hospital Cancer Treatment Center Recruiting
Cincinnati, Ohio, United States, 45220
Contact: Robert E. Albright, MD     513-936-5370     ralbright@ohcmail.com    
United States, Oregon
Knight Cancer Institute at Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea     503-494-1080     trials@ohsu.edu    
Sponsors and Collaborators
Oregon Health and Science University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Edward A. Neuwelt, MD OHSU Knight Cancer Institute
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Knight Cancer Institute at Oregon Health and Science University ( Edward A. Neuwelt )
Study ID Numbers: CDR0000346101, OHSU-7328, OHSU-ONC-02059-L, CASE-CCF-6385
Study First Received: January 9, 2004
Last Updated: June 25, 2009
ClinicalTrials.gov Identifier: NCT00075387     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
thrombocytopenia
adult glioblastoma
adult anaplastic ependymoma
adult anaplastic oligodendroglioma
recurrent adult brain tumor
adult giant cell glioblastoma
 adult gliosarcoma
adult anaplastic astrocytoma
adult pineal gland astrocytoma
adult brain stem glioma
adult mixed glioma

Study placed in the following topic categories:
Anti-Infective Agents
Glioblastoma
Antioxidants
Immunologic Factors
Central Nervous System Neoplasms
Cyclophosphamide
Etoposide phosphate
Ependymoma
Anti-Bacterial Agents
Thrombocytopenia
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Alkylating Agents
Etoposide
 Nervous System Neoplasms
Astrocytoma
Hematologic Diseases
Blood Platelet Disorders
Sodium thiosulfate
Carboplatin
Immunosuppressive Agents
Recurrence
Neuroectodermal Tumors
Brain Neoplasms
Thrombocytopathy
Oligodendroglioma
Chelating Agents
Antitubercular Agents
Antineoplastic Agents, Alkylating

Additional relevant MeSH terms:
Anti-Infective Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Central Nervous System Neoplasms
Cyclophosphamide
Etoposide phosphate
Anti-Bacterial Agents
Neoplasms by Site
Thrombocytopenia
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
 Glioma
Alkylating Agents
Etoposide
Nervous System Neoplasms
Antidotes
Neoplasms by Histologic Type
Hematologic Diseases
Blood Platelet Disorders
Nervous System Diseases
Sodium thiosulfate
Carboplatin
Protective Agents
Immunosuppressive Agents
Pharmacologic Actions
Neuroectodermal Tumors

ClinicalTrials.gov processed this record on September 04, 2009



Contact Help Desk
Lister Hill National Center for Biomedical Communications,  U.S. National Library of Medicine,
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services