NEWLY DIAGNOSED CHILDREN (LESS THAN 10 YEARS OLD) WITH MEDULLOBLASTOMA AND OTHER CENTRAL NERVOUS SYSTEM EMBRYONAL TUMORS: CLINICAL AND MOLECULAR RISK-TAILORED INTENSIVE AND COMPRESSED INDUCTION CHEMOTHERAPY FOLLOWED BY CONSOLIDATION WITH EITHER SINGLE CYCLE (LOW RISK PATIENTS) OR RANDOMIZATION (HIGH RISK PATIENTS) TO either SINGLE-CYCLE or TO THREE TANDEM CYCLES OF MARROW-ABLATIVE CHEMOTHERAPY WITH AUTOLOGOUS HEMATOPOIETIC PROGENITOR CELL RESCUE
S
Scott Coven
Primary Investigator
Enrolling By Invitation
10 years and younger
All
Phase
N/A
10 participants needed
3 Locations
Overview
What is the purpose of this study?
This research study would like to learn more information about patients who have been diagnosed with medulloblastoma and other CNS embryonal tumors. This research study will compare two different treatment regimens to see which is better for treating your child’s type of brain cancer.
Goals
· To test tumor for biologic markers that will help us know how to best treat each subject on this treatment study. This includes genetic testing about your cancer.
· To measure any effects that this treatment has on the subjects quality of life (general well-being).
· To measure the brain function of subjects (measuring intelligence, memory, language, non-verbal skills, attention and academic achievement) and to examine the relationship between the child’s level of brain function and is/her quality of life.
· To measure any effects that this treatment has on hearing.
Additional research aims that are optional:
· To test a blood sample for markers that will help us know how to best identify subjects that may have hearing problems during treatment.
· To test a sample of tumor tissue, spinal fluid and blood to see if biological and genetic characteristics of these tissues and blood relate to how well your child responds to treatment.
· To measure any effects that this treatment has on the subjects quality of life (general well-being).
· To measure the brain function of subjects (measuring intelligence, memory, language, non-verbal skills, attention and academic achievement) and to examine the relationship between the child’s level of brain function and is/her quality of life.
· To measure any effects that this treatment has on hearing.
Additional research aims that are optional:
· To test a blood sample for markers that will help us know how to best identify subjects that may have hearing problems during treatment.
· To test a sample of tumor tissue, spinal fluid and blood to see if biological and genetic characteristics of these tissues and blood relate to how well your child responds to treatment.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Description
What will happen during the study?
This research study has two parts. This Consent Form is only for the first part of the study called Induction. During Induction, a test will be done on your child’s tumor for biologic and genetic markers that will help us to know how to best treat your child on this research study. Your child will be given either 3 cycles or 5 cycles of chemotherapy. Your child will also have a procedure performed called leukapheresis in which some of his/her own blood cells are collected and stored for later use.
The second part of the research study is called Consolidation. Based on the results of the tumor marker tests discussed above, your child may receive either a single cycle of Consolidation drug therapy or, your child may be randomized to either a single or multiple (three) cycles of Consolidation drug therapy. If your child will be randomized, the treatment he/she will receive (single or multiple consolidation cycles) is decided by a process called randomization. Randomization means that the treatment is assigned based on chance. It is a lot like flipping a coin, except that it is done by a computer to make sure that there are about the same number of people on each treatment arm of the study. Your child will have an equal chance of being placed in either of the treatment arms.
The second part of the research study is called Consolidation. Based on the results of the tumor marker tests discussed above, your child may receive either a single cycle of Consolidation drug therapy or, your child may be randomized to either a single or multiple (three) cycles of Consolidation drug therapy. If your child will be randomized, the treatment he/she will receive (single or multiple consolidation cycles) is decided by a process called randomization. Randomization means that the treatment is assigned based on chance. It is a lot like flipping a coin, except that it is done by a computer to make sure that there are about the same number of people on each treatment arm of the study. Your child will have an equal chance of being placed in either of the treatment arms.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
Medulloblastoma, Central Nervous System Embryonal Tumors, Riley
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Age: - 10 Years
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Gender: All
Inclusion Criteria
- Patients 10 years of age at the time of definitive confirmatory eligible histologic or cytologic diagnosis of eligible CNS tumor (brain or spinal cord)
- Patients may not have received irradiation or chemotherapy (except corticosteroids)
- Have histologically proven diagnosis of medulloblastoma or CNS embryonal tumors of the brain or spinal cord
- Medulloblastoma
- Posterior fossa classic, desmoplastic or extensive nodular or anaplastic/large cell medulloblastoma with appropriate and sufficient tumor material (FFPE or snap frozen) for proposed assays: all stages, age less than 6 years at diagnosis
- Posterior fossa classic or anaplastic/large cell medulloblastoma with sufficient tumor material (FFPE or snap frozen) for proposed assays: clinically high-stage (neuraxis or extra-neural dissemination, M1-4), age greater than 6 years to less than 10 years at diagnosis
- Posterior fossa medulloblastoma, those 6 years of age and above at diagnosis, will only be eligible if they have evidence of neuraxis or extraneural dissemination. Patients 6 years of age and above with low-stage (standard-risk, M0) medulloblastoma will NOT be eligible for this study, irrespective of molecular subgroup and extend of local resection
- CNS Embryonal Tumors: - Pineoblastoma, CNS neuroblastoma, CNS ganglioneuroblastoma, embryonal tumor with multi-layered rosettes (ETMR, including embryonal tumor with abundant neuropil and true rosettes (ETANTR), ependymoblastoma and ETMR not otherwise specified), medulloepithelioma, CNS embryonal tumor with rhabdoid features (INI1 intact) and CNS embryonal tumor, not otherwise specified.
- Must commence Induction chemotherapy within 28 days of the most recent definitive surgical procedure and within 21 days of the most recent neuro-imaging studies (MRI of brain, performed with and without gadolinium contrast, and MRI of total spine, performed with gadolinium contrast) and lumbar CSF cytological examination
- Patients must have adequate organ functions at the time of registration
- Patients older than 10 years of age at time of diagnosis
- Following diagnoses are not eligible for study enrollment: CNS atypical teratoid/rhabdoid tumor (AT/RT); all ependymomas including anaplastic ependymomas of the brain or spinal cord; all choroid plexus carcinomas; all high-grade glial and glio-neuronal tumors; all primary CNS germ cell tumors; all primary CNS sarcomas; all primary or metastatic CNS lymphomas and solid leukemic lesions (i.e., chloromas, granulocytic sarcomas)
- Patients with unbiopsied diffuse intrinsic pontine tumors will NOT be eligible for this study.
Updated on
12 Sep 2024.
Study ID: 1610647607, PHO-SHIH-NWC-HEADSTART4, TX7574
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