Trial record 1 of 1 for:
ACNS0831
Maintenance Chemotherapy or Observation Following Induction Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Ependymoma
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| ClinicalTrials.gov Identifier: NCT01096368 |
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Recruitment Status :
Recruiting
First Posted : March 31, 2010
Last Update Posted : October 18, 2018
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Sponsor:
Children's Oncology Group
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
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Brief Summary:
This partially randomized phase III trial is studying maintenance chemotherapy to see how well it works compared to observation following induction chemotherapy and radiation therapy in treating young patients with newly diagnosed ependymoma. Drugs used in chemotherapy, such as vincristine sulfate, carboplatin, cyclophosphamide, etoposide, and cisplatin, 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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving chemotherapy with radiation therapy may kill more tumor cells and allow doctors to save the part of the body where the cancer started.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cellular Ependymoma Childhood Anaplastic Ependymoma Childhood Infratentorial Ependymoma Childhood Supratentorial Ependymoma Clear Cell Ependymoma Ependymoma Newly Diagnosed Childhood Ependymoma Papillary Ependymoma | Radiation: 3-Dimensional Conformal Radiation Therapy Drug: Carboplatin Drug: Cisplatin Other: Clinical Observation Drug: Cyclophosphamide Drug: Etoposide Other: Laboratory Biomarker Analysis Drug: Vincristine Sulfate Liposome | Phase 3 |
Show Detailed Description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 500 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients With Newly Diagnosed Ependymoma Ages 1 to 21 Years |
| Actual Study Start Date : | March 29, 2010 |
| Estimated Primary Completion Date : | December 31, 2021 |
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| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm I (radiotherapy, chemotherapy)
Patients receive vincristine sulfate IV over 1 minute on days 1 and 8 of courses 1 and 2, carboplatin IV over 15-60 minutes on day 1 of courses 1 and 2, and cyclophosphamide IV over 30-60 minutes on days 1-2 of course 1 only. Patients also receive etoposide IV over 60-120 minutes on days 1-3 of course 2 only. Course 1 continues for 3 weeks and course 2 continues for 4 weeks in the absence of disease progression or unacceptable toxicity.
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Drug: Carboplatin
Given IV
Other Names:
Drug: Cyclophosphamide Given IV
Other Names:
Drug: Etoposide Given IV
Other Names:
Other: Laboratory Biomarker Analysis Optional correlative studies Drug: Vincristine Sulfate Liposome Given IV
Other Name: Marqibo |
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Experimental: Arm II (radiotherapy, chemotherapy)
Patients undergo conformal radiotherapy over 6-7 weeks. Patients then receive vincristine sulfate IV on days 1, 8, and 15 of courses 1-3 only, etoposide IV over 60-120 minutes on days 1-3, cisplatin IV over 1-8 hours on day 1, and cyclophosphamide IV over 30-60 minutes on days 2-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
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Radiation: 3-Dimensional Conformal Radiation Therapy
Patients undergo conformal radiotherapy
Other Names:
Drug: Cisplatin Given IV
Other Names:
Drug: Cyclophosphamide Given IV
Other Names:
Drug: Etoposide Given IV
Other Names:
Other: Laboratory Biomarker Analysis Optional correlative studies Drug: Vincristine Sulfate Liposome Given IV
Other Name: Marqibo |
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Active Comparator: Arm III (radiotherapy, observation)
Patients undergo conformal radiotherapy over 6-7 weeks and then undergo observation.
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Radiation: 3-Dimensional Conformal Radiation Therapy
Patients undergo conformal radiotherapy
Other Names:
Other: Clinical Observation Patients undergo observation
Other Name: observation Other: Laboratory Biomarker Analysis Optional correlative studies |
Primary Outcome Measures :
- Event-free survival (EFS) [ Time Frame: From first occurrence of disease progression, disease recurrence, second malignant neoplasm, or death from any cause, assessed up to 5 years ]Using Kaplan-Meier curves to estimate the observed EFS for the two randomization arms (post-radiation maintenance arm and post-radiation observation only arm). Log rank tests will be used to compare the observed EFS between the two randomization arms. Stratified log rank test will also be performed to examine the treatment difference with consideration and adjustment for the randomization groups. If outcome data on ACNS0121 or this study suggest a difference or a different pattern in outcome between the 2 randomization strata, the primary analyses will be supplemented with log-rank tests performed separately in each stratum in order not to confound the overall conclusions of the study with respect to the effect of maintenance therapy.
- Overall survival (OS) [ Time Frame: From the time of randomization to death, assessed up to 5 years ]Using Kaplan-Meier curves to estimate the observed OS for the two randomization arms (post-radiation Maintenance arm and post-radiation Observation only arm). Log rank tests will be used to compare the observed OS between the two randomization arms. Stratified log rank test will also be performed to examine the treatment difference with consideration and adjustment for the randomization groups. If outcome data on ACNS0121 or this study suggest a difference or a different pattern in outcome between the 2 randomization strata, the primary analyses will be supplemented with log-rank tests performed separately in each stratum in order not to confound the overall conclusions of the study with respect to the effect of maintenance therapy.
Secondary Outcome Measures :
- Event free survival (EFS) of children with incompletely resected ependymoma who are unable to achieve a complete response (CR) by post-operative induction chemotherapy or by second surgery [ Time Frame: Up to 5 years ]Kaplan-Meier curves will be used to estimate the EFS for patients who were non-randomly assigned to receive maintenance chemotherapy after incomplete resection
- Overall survival (OS) of children with incompletely resected ependymoma who are unable to achieve a complete response (CR) by post-operative induction chemotherapy or by second surgery [ Time Frame: Up to 5 years ]Kaplan-Meier curves will be used to estimate the OS for patients who were non-randomly assigned to receive maintenance chemotherapy after incomplete resection
- Event free survival (EFS) of children with supratentorial classic ependymoma who achieve complete resection at first or second surgery or children who achieve complete response (CR) after induction chemo assigned to observation [ Time Frame: Up to 5 years ]Estimated using Kaplan-Meier curves for patients with supratentorial classic disease that achieve complete resection or CR to induction chemotherapy and are assigned to observation only.
- Overall survival (OS) of children with supratentorial classic ependymoma who achieve complete resection at first or second surgery or children who achieve complete response (CR) after induction chemo assigned to observation [ Time Frame: Up to 5 years ]Estimated using Kaplan-Meier curves for patients with supratentorial classic disease that achieve complete resection or CR to induction chemotherapy and are assigned to observation only.
- Neurologic, neuropsychological, and endocrine long-term sequelae of surgery, conformal radiotherapy, and maintenance chemotherapy [ Time Frame: At 9, 30, and 60 months post diagnosis ]Will be observed.
- Gene expression signatures and genomic alterations in pediatric ependymoma [ Time Frame: At the time of first or second surgery ]Will be observed.
- Telomere maintenance [ Time Frame: Up to 5 years ]Descriptive statistics will be used to summarize the various telomere maintenance measures. Log rank tests and multivariate Cox proportional hazards models will be used to explore the association between a telomere maintenance measurement and EFS/OS, with potential adjustments for the effects of other possible prognostic factors. Reliability of human telomerase reverse transcriptase (hTERT) immunohistochemistry results versus telomeric repeat amplification protocol (TRAP) assay results will be calculated using the kappa statistic.
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| Ages Eligible for Study: | 13 Months to 20 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients must be newly diagnosed with histologically confirmed intracranial ependymoma; patients with classic ependymoma (WHO II) or anaplastic ependymoma (WHO III) are eligible, as are various subtypes described as clear cell, papillary, cellular or a combination of the above
- There is no minimum performance level; children with ependymoma may suffer neurologic sequelae as a result of their tumor or surgical measures taken to establish a diagnosis and resect the tumor; in the majority of cases, there is neurologic recovery; neurologic recovery is not likely to be impeded by protocol therapy
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
- Patients with evidence of metastatic disease will be excluded; any evidence of non-contiguous spread beyond the primary site as determined by pre or post-operative magnetic resonance (MR) imaging of brain, pre or post-operative MR imaging of the spine, and post-operative cerebrospinal fluid (CSF) cytology obtained from the lumbar CSF space (the requirement for lumbar CSF examination may be waived if deemed to be medically contraindicated); CSF cytology from a ventriculostomy or permanent ventriculoperitoneal (VP) shunt that reveals the presence of tumor cells is indicative of metastatic disease
- Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, or mixed glioma are NOT eligible
- No prior treatment other than surgical intervention and corticosteroids; patients are allowed to have had more than one attempt at resection prior to enrollment
- Pregnant female patients are not eligible for this study
- Post-menarchal females may not participate unless a pregnancy test with a negative result has been obtained
- Males and females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method
- Lactating females may not participate unless they have agreed not to breastfeed a child while on this study
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096368
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Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Amy Smith | Children's Oncology Group |
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT01096368 History of Changes |
| Other Study ID Numbers: |
ACNS0831 NCI-2011-02029 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) COG-ACNS0831 CDR0000668560 10-01676 ACNS0831 ( Other Identifier: Childrens Oncology Group ) ACNS0831 ( Other Identifier: CTEP ) U10CA180886 ( U.S. NIH Grant/Contract ) U10CA098543 ( U.S. NIH Grant/Contract ) |
| First Posted: | March 31, 2010 Key Record Dates |
| Last Update Posted: | October 18, 2018 |
| Last Verified: | August 2018 |
Additional relevant MeSH terms:
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Ependymoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Etoposide phosphate Cisplatin Cyclophosphamide Carboplatin Etoposide Vincristine |
Podophyllotoxin Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Myeloablative Agonists Antineoplastic Agents, Phytogenic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Tubulin Modulators |