MDACC Study Summary 2006-0110 (Archived)

Study Summary
No. 2006-0110:.......Brain; CNS; Pediatrics......Robert J. Wells......Pediatrics

Study Summary Title



Study Summary Number:	2006-0110

Study Title:	DOSE INTENSIVE CHEMOTHERAPY FOR CHILDREN LESS THAN TEN YEARS OF AGE NEWLY DIAGNOSED WITH MALIGNANT BRAIN TUMORS: A PILOT STUDY OF TWO ALTERNATIVE INTENSIVE INDUCTION CHEMOTHERAPY REGIMENS, FOLLOWED BY CONSOLIDATION WITH MYELOABLATIVE CHEMOTHERAPY (THIOTEPA AND CARBOPLATIN, WITH OR WITHOUT ETOPOSIDE) AND AUTOLOGOUS STEM CELL RESCUE

Physician

New Patient Referral



Name:	Robert J. Wells	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Pediatrics	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-0774 Contact us about clinical trials

General Information



Disease Group:	Brain CNS Pediatrics	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	Will require at least weekly visits to the hospital during chemotherapy, daily (weekdays) during radiation and after the stem cell infusion for monitoring.

Treatment Agents:	Carboplatin Cisplatin Cyclophosphamide Etoposide Filgrastim Leucovorin Mesna Methotrexate Temozolomide Thiotepa Vincristine	Home Care:	G-CSF injection once a day after each course of chemotherapy can be administered at home. Etoposide given by mouth Temozolomide will be given by mouth

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Induction phase: 28-35 day cycle for 5 cycles (3-5 months) Consolidation phase: 6 days of chemo, 8 days to 6 weeks for BM recovery Radiation will be given once daily, five days per week (Mondays through Fridays) for a period of about 4 to 6 weeks


Description/ Intervention:	The goal of this clinical research study is to learn if intensive chemotherapy, followed by a highly intensive treatment with a blood stem-cell rescue procedure, can improve survival for young children with malignant brain tumors. Researchers will also look at the effects and safety of lower-dose radiation therapy on normal brain development.

Study Objectives / Outcomes

Primary Aims:

Determine 2 year EFS and OS from study enrollment, for children with non-disseminated medulloblastoma < 4 years of age, disseminated medulloblastoma <10 years of age at study enrollment, and all non-cerebellar primitive neuroectodermal tumors (PNET), disseminated or non-disseminated, <10 years of age at study enrollment, treated with induction chemotherapy Regimen D followed by consolidation with myeloablative chemotherapy and autologous hematopoietic cell rescue.

1a Determine the 2 year EFS and OS from study enrollment children treated on Regimen D2 followed by consolidation with myeloablative chemotherapy and autologous hematopoietic cell rescue, where Regimen D2 is the result of reductions in doses of IV methotrexate and cyclophosphamide and changes in supportive care measure in response to excessive toxic death rate with Regimen D.

2. Determine toxicity and mortality of induction therapy and myeloablative consolidation therapy in patients of all diagnoses.

2a To determine whether Regimen D2 results in a reduction in toxicity and toxicity mortality of treatment, especially in children under 24 months of age.

3.

Secondary Aims:

4 Determine the two-year EFS and OS from time of enrollment for patients with high-grade glioma treated on Regimen C in a combined analysis with data from the Head Start II study treated on the same Regimen.

5 Determine CR and PR rates at end of induction therapy stratified by following pathologies:

6. EFS and OS of patients stratified by following additional gnoses treated on this protocol:

7. Describe time to progression and patterns of relapse in patients stratified by diagnosis and radiation therapy:

8. Determine neuropsychometric function, endocrinologic function and physical growth in children on this protocol stratified by radiation therapy received:

Study Status Information



Study Activation / Registration Date:	08/08/2006

IRB Review and Approval Date:	05/03/2006

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	150

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Children less than 120 months (10 years) of age at the time of definitive confirmatory histologic or cytologic diagnosis of a malignant brain tumor who have not previously received either irradiation or chemotherapy (excepting corticosteroids) will be eligible for study entry.

2) Histologic diagnosis is mandatory for all patients prior to study entry. Study eligibility will be based on institutional pathology.

3) Children must commence induction chemotherapy within 42 days of the most recent definitive surgical procedure.

4) Children with posterior fossa medulloblastoma will be eligible for this study, but those 4 years of age and above at diagnosis will only be eligible if they have evidence of residual tumor post-operatively (>1.5 cm� tumor area), or have evidence of neuraxis or extraneural dissemination.

5) Children with ependymoma (cellular, anaplastic, but NOT myxo-papillary) will be eligible only if under 36 months of age at diagnosis (for posterior fossa tumor); less than 72 months of age (for supratentorial tumors) or irrespective of primary site if under 10 years of age with evidence of neuraxis dissemination.

6) Patients with a brainstem tumors that are pathologically confirmed to be either malignant gliomas, ependymomas or PNET, will be eligible for study entry.

7) Adequate hepatic function defined as: bilirubin less than 1.5 mg/dL and transaminases [SGPT or ALT, and SGOT or AST] less than 2.5 times the upper limits of institutional normal; Creatinine clearance and/or glomerular filtration rate greater than or equal to 60 ml/min/1.73m�.

8) Patient's family or legal guardian must acknowledge in writing consent to become a participant in this study in accordance with institutional policies in accord with the United States Department of Health and Human Services (DHHS).

9) Approval for the use of this treatment regimen by the individual institution's Human Rights Committee or Institutional Review Board (IRB) must be obtained in accordance with the individual institutional assurance policies.

Exclusion Criteria:

1) Patients with Choroid Plexus Papilloma, Pineocytoma, Low Grade Gliomas, Unbiopsied Diffuse Intrinsic Pontine Tumors, Primary CNS Germ Cell Tumors or Atypical Teratoid Rhabdoid Tumors (AT/RT) will NOT be eligible for this study.

2) Patients 4 years of age and above with low stage (standard risk) medulloblastoma will NOT be eligible for this study.

3) Patients with cellular (low-grade) supratentorial ependymomas at any age with complete resection of entirely parenchymally based (i.e. not periventricular) tumors, and without evidence of metastatic disease, will NOT be eligible for study entry.

4) No patients with unbiopsied diffuse intrinsic pontine tumor will be enrolled on this study.

Links

Registration Number: NCT00392886
Study Information on Clinical Trials Registry (clinicaltrials.gov)