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| Sponsors and Collaborators: |
Oregon Health and Science University National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00238173 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, etoposide phosphate, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Mannitol may help chemotherapy work better by making it easier for these drugs to get to the tumor. Chemoprotective drugs, such as acetylcysteine and sodium thiosulfate, may protect normal cells from the side effects of chemotherapy. Giving acetylcysteine together with mannitol, combination chemotherapy, and sodium thiosulfate may be an effective treatment for malignant brain tumors.
PURPOSE: This phase I trial is studying the side effects and best dose of acetylcysteine when given together with mannitol, combination chemotherapy, and sodium thiosulfate in treating children with malignant brain tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Cancer-Related Problem/Condition |
Biological: filgrastim Drug: acetylcysteine Drug: carboplatin Drug: cyclophosphamide Drug: etoposide phosphate Drug: mannitol Drug: sodium thiosulfate |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Dose Escalation Study of N-Acetylcysteine Administered in Conjunction With Carboplatin, Cyclophosphamide, and Etoposide Phosphate BBBD, in Children With Malignant Brain Tumors |
| Study Start Date: | December 2004 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a dose-escalation study of acetylcysteine.
Patients receive acetylcysteine IV over 30-60 minutes followed, at least 15 minutes later, by x-ray-guided femoral artery catheterization under general anesthesia on days 1 and 2. After placement of the catheter, patients receive cyclophosphamide IV over 10 minutes, etoposide phosphate IV over 10 minutes, mannitol intra-arterially (IA) over 30 seconds, and carboplatin IA over 10 minutes also on days 1 and 2. Patients then receive high-dose sodium thiosulfate IV over 15 minutes 4 hours after completion of carboplatin. Some patients may receive a second dose of sodium thiosulfate 8 hours after completion of carboplatin. Beginning 48 hours after the last dose of chemotherapy on day 2, patients receive filgrastim (G-CSF) subcutaneously once daily for 7-10 days or until blood counts recover. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of acetylcysteine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. An additional 3 patients are treated at the MTD.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 1 Year to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed brain tumors, including any of the following:
Diagnosis based on any of the following:
PATIENT CHARACTERISTICS:
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Chemotherapy
Radiotherapy
Surgery
Contacts and Locations| United States, Oregon | |
| Cancer Institute at Oregon Health and Science University | |
| Portland, Oregon, United States, 97239-3098 | |
| Principal Investigator: | Edward A. Neuwelt, MD | Oregon Health and Science University |
More Information
| Study ID Numbers: | CDR0000445041, OHSU-8522, OHSU-SOL-04085-L |
| Study First Received: | October 12, 2005 |
| Last Updated: | April 4, 2009 |
| ClinicalTrials.gov Identifier: | NCT00238173 History of Changes |
| Health Authority: | United States: Federal Government |
|
drug/agent toxicity by tissue/organ bone marrow suppression long-term effects secondary to cancer therapy in children recurrent childhood brain stem glioma untreated childhood brain stem glioma childhood central nervous system germ cell tumor recurrent childhood supratentorial primitive neuroectodermal tumor recurrent childhood visual pathway and hypothalamic glioma recurrent childhood brain tumor recurrent childhood cerebellar astrocytoma childhood high-grade cerebral astrocytoma childhood low-grade cerebral astrocytoma recurrent childhood cerebral astrocytoma |
recurrent childhood medulloblastoma childhood oligodendroglioma childhood infratentorial ependymoma childhood supratentorial ependymoma recurrent childhood ependymoma childhood central nervous system choriocarcinoma childhood central nervous system embryonal tumor childhood central nervous system germinoma childhood central nervous system mixed germ cell tumor childhood central nervous system teratoma childhood central nervous system yolk sac tumor recurrent childhood central nervous system embryonal tumor |
|
Antioxidants Neuroectodermal Tumors, Primitive Immunologic Factors Diuretics Central Nervous System Neoplasms Cyclophosphamide Brain Diseases Etoposide phosphate Ependymoma Anti-Bacterial Agents Mannitol Neoplasm Metastasis Neuroepithelioma Acetylcysteine Glioma |
Alkylating Agents Etoposide Nervous System Neoplasms Astrocytoma Choriocarcinoma Sodium thiosulfate Central Nervous System Diseases Brain Tumor, Childhood Cardiovascular Agents Carboplatin Immunosuppressive Agents Antiviral Agents Recurrence Neuroectodermal Tumors Brain Neoplasms |
|
Respiratory System Agents Anti-Infective Agents Antioxidants Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Diuretics Physiological Effects of Drugs Cyclophosphamide Central Nervous System Neoplasms Brain Diseases Etoposide phosphate Anti-Bacterial Agents Neoplasms by Site Mannitol |
Therapeutic Uses Free Radical Scavengers Acetylcysteine Alkylating Agents Etoposide Nervous System Neoplasms Antidotes Diuretics, Osmotic Nervous System Diseases Sodium thiosulfate Central Nervous System Diseases Cardiovascular Agents Carboplatin Immunosuppressive Agents Protective Agents |
