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

NCT00075387 | Unknown Phase 2 DMC

• 9 other identifiers: IRB00000922NCI-2013-00781eIRB #922ONC-02019-LCR00023930MR00041590CR00021317CR00018679CR00022743
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 3

Brief Summary

This randomized phase II trial studies how well giving combination chemotherapy with or without sodium thiosulfate works in preventing low platelet count while treating patients with malignant brain tumors. Drugs used in chemotherapy, such as carboplatin, cyclophosphamide, and etoposide phosphate, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Sodium thiosulfate may prevent low platelet counts in patients receiving chemotherapy. It is not yet known whether combination chemotherapy is more effective with or without sodium thiosulfate in preventing low platelet count during treatment for brain tumors.

Conditions

Malignant Glioma

Outcome Measures

Primary Outcomes (1)

• 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

  The Pearson chi-square test will be the primary test to compare rates.

  Up to 4 weeks after completion of study treatment

Secondary Outcomes (8)

• Number of dose reductions and transfusions due to platelet toxicity

  Up to 30 days after completion of study treatment

• Tumor response (complete response + partial response + stable disease) assessed by neurologic exams, radiographic studies, and steroid dose

  Up to 10 years

• Time to response

  Up to 10 years

• Time to disease progression

  Up to 10 years

• Granulocyte count

  Up to 30 days after completion of study treatment

Study Arms (2)

Arm I (combination chemotherapy)

EXPERIMENTAL

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.

Drug: Carboplatin; Drug: Cyclophosphamide; Drug: Etoposide Phosphate; Other: Quality-of-Life Assessment

Arm II (combination chemotherapy, sodium thiosulfate)

EXPERIMENTAL

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.

Drug: Carboplatin; Drug: Cyclophosphamide; Drug: Etoposide Phosphate; Other: Quality-of-Life Assessment; Drug: Sodium Thiosulfate

Interventions

Carboplatin DRUG

Given IA

Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Arm I (combination chemotherapy); Arm II (combination chemotherapy, sodium thiosulfate)

Cyclophosphamide DRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719

Arm I (combination chemotherapy); Arm II (combination chemotherapy, sodium thiosulfate)

Etoposide Phosphate DRUG

Given IV

Also known as: Etopophos

Arm I (combination chemotherapy); Arm II (combination chemotherapy, sodium thiosulfate)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (combination chemotherapy); Arm II (combination chemotherapy, sodium thiosulfate)

Sodium Thiosulfate DRUG

Given IV

Also known as: Cyanide Antidote Package, Disodium Thiosulfate, S-Hydril, Sodium Hyposulfate, Sodium Thiosulfate Pentahydrate, Sodium Thiosulphate, Sodothiol, Thiosulfate, Sodium, Pentahydrate, Thiosulfuric acid disodium salt

Arm II (combination chemotherapy, sodium thiosulfate)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with histologically confirmed high-grade glioma are eligible; diagnosis of high-grade glioma will be made on the basis of needle biopsy, open biopsy, or surgical resection
• Subjects may have had prior focal or systemic radiation or chemotherapy; at least 14 days must have elapsed since radiation treatment and 28 days since prior chemotherapy
• Performance status (Eastern Cooperative Oncology Group \[ECOG\]) must be less than or equal to 2 (Karnofsky greater than or equal to 50)
• White blood cell count \>= 2.5 x 10\^3/mm\^3
• Absolute granulocyte count \>= 1.2 x 10\^3/mm\^3
• Platelets \>= 100 x 10\^3/mm\^3
• Creatinine \< 1.8
• Bilirubin \< 2.0
• Baseline aspartate aminotransferase (AST)/alanine aminotransferase (ALT) serum glutamic oxaloacetic transaminase (SGOT)/serum glutamate pyruvate transaminase (SGPT) must be \< 2.5 x institutional upper limits of normal
• Subject (or legal guardian) must sign a written informed consent in accordance with institutional guidelines
• Sexually active women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; or abstinence) prior to study treatment and for the duration of study treatment; should a female become pregnant or suspect she is pregnant while participating in this study, she should inform the investigator

You may not qualify if:

• Subjects with rapidly progressing central nervous system (CNS) disease with associated neurological deterioration
• Subjects with uncontrolled (over the last 30 days) clinically significant confounding medical conditions such as congestive heart failure
• Subjects who are pregnant, have a positive serum human chorionic gonadotropin (hCG) or are lactating
• Subjects who have contraindications to carboplatin, cyclophosphamide, etoposide phosphate, or sodium thiosulfate

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Oregon Health and Science University: collaborator

Study Sites (3)

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Glioma

Interventions

Carboplatin; Cyclophosphamide; etoposide phosphate; sodium thiosulfate

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds

Study Officials

• Edward A Neuwelt

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2004
• First Posted: January 12, 2004
• Study Start: March 7, 2003
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2024
• Last Updated: May 3, 2022

Record last verified: 2022-04

Locations

US (3)