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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00352313 |
RATIONALE: ATN-161 may stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving ATN-161 together with carboplatin may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of ATN-161 when given together with carboplatin and to see how well they work in treating patients with recurrent malignant glioma.
Condition | Intervention | Phase |
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Brain and Central Nervous System Tumors |
Drug: ATN-161 Drug: carboplatin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase I/II Study of ATN-161 and Carboplatin in Adult Patients With Recurrent Intracranial Malignant Glioma |
Estimated Enrollment: | 82 |
Study Start Date: | May 2006 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Phase I: Experimental
Patients receive ATN-161 IV over 10 minutes 3 times weekly in weeks 1-6 and carboplatin IV over 20 minutes in week 3 during course 1. Beginning in course 2, patients receive carboplatin IV over 20 minutes in week 1 and ATN-161 IV over 10 minutes 3 times weekly in weeks 1-4. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
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Drug: ATN-161
Given IV
Drug: carboplatin
Given IV
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Phase II: Experimental
Patients receive carboplatin IV in week 1 and ATN-161 IV, at the MTD determined in phase I, 3 times weekly in weeks 1-4. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
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Drug: ATN-161
Given IV
Drug: carboplatin
Given IV
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open-label, phase I dose-escalation study of ATN-161 followed by a phase II study. Patients in the phase II portion of the study are stratified according to tumor type (glioblastoma multiforme vs anaplastic glioma).
Phase I: Patients receive ATN-161 IV over 10 minutes 3 times weekly in weeks 1-6 and carboplatin IV over 20 minutes in week 3 during course 1. Beginning in course 2, patients receive carboplatin IV over 20 minutes in week
1 and ATN-161 IV over 10 minutes 3 times weekly in weeks 1-4. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ATN-161 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 during the first 6 weeks of treatment.
After completion of study treatment, patients are followed for 28 days.
PROJECTED ACCRUAL: A total of 82 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed intracranial malignant glioma
Any of the following diagnoses:
Recurrent disease
Must have failed prior radiotherapy
Prior recent resection of recurrent or progressive tumors allowed if all of the following criteria are met:
Unequivocal evidence of tumor progression by MRI
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
Bethesda, Maryland, United States, 20892-1182 |
Principal Investigator: | Howard A. Fine, MD | NCI - Neuro-Oncology Branch |
Study ID Numbers: | CDR0000487605, NCI-06-C-0170, NCI-P6790, ATN-161-002 |
Study First Received: | July 13, 2006 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00352313 History of Changes |
Health Authority: | United States: Food and Drug Administration |
adult anaplastic oligodendroglioma adult gliosarcoma adult mixed glioma adult anaplastic astrocytoma |
recurrent adult brain tumor adult glioblastoma adult giant cell glioblastoma |
Glioblastoma Astrocytoma Carboplatin Central Nervous System Neoplasms Recurrence Brain Neoplasms Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neuroepithelioma Oligodendroglioma Glioma Gliosarcoma Nervous System Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Antineoplastic Agents Neoplasms, Nerve Tissue Nervous System Diseases Central Nervous System Neoplasms Carboplatin Pharmacologic Actions Neuroectodermal Tumors |
Neoplasms Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Glioma Neoplasms, Neuroepithelial Nervous System Neoplasms Neoplasms, Glandular and Epithelial |