MDACC Study Summary 2005-0658 (Archived)

Study Summary
No. 2005-0658:.......CNS; Pediatrics......Johannes Wolff......Pediatrics

Study Summary Title



Study Summary Number:	2005-0658

Study Title:	Treatment of Children and Adolescents with Diffuse Intrinsic Pontine Glioma and High Grade Glioma

Physician

New Patient Referral



Name:	Johannes Wolff	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:	CNS Pediatrics	Supported By:	N/A

Phase of Study:	Phase III	Return Visit:	Once weekly for counts and status monitoring during active treatment. Following protocol therapy, patients will return for follow-up visits and/or evaluations every 3 months for the first year, every 6 months for 2nd year and annually thereafter.

Treatment Agents:	CCNU Cisplatin Etoposide Ifosfamide Mesna Methotrexate Prednisone Vincristine	Home Care:	Treatment during the consolidation phase can be administered at home except during vincristine infusion. Lomustine (CCNU), prednisone and GCSF (if needed) may be administered orally at home, according to protocol guidelines.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	Patient require hospitalization during induction phase with methotrexate infusion, at least 4 days each cycle and up to 7 days each cycle during chemoradiation phase. No hospitalization required during consolidation phase. Treatment is given orally.

Description/
Intervention:

The goal of this clinical research study is to find out if giving high-dose
methotrexate after surgery and before radiation therapy will improve overall
survival and the standard of care for children and young adults with high-grade
malignant glioma or diffuse intrinsic pontine glioma as compared to standard
treatment of surgery, radiation, and/or chemotherapy. The safety of this
treatment will also be studied.

Study Objectives / Outcomes

The overall goal of the study is to improve overall survival and the standard of care for children and young adults with high-grade malignant glioma or diffuse intrinsic pontine glioma.

The primary hypothesis of the HIT-GBM-D protocol:

The addition of high-dose methotrexate prior to standard treatment will improve survival of patients with high-grade malignant glioma or diffuse intrinsic pontine glioma as compared to standard treatment.

Secondary Hypothesis:

1. The addition of high-dose methotrexate will improve the tumor response of patients with high-grade malignant glioma or diffuse intrinsic pontine glioma as compared to standard treatment.

2. The addition of high-dose methotrexate will improve the progression free or event free survival of patients with high-grade malignant glioma or diffuse intrinsic pontine glioma as compared to standard treatment.

3. The addition of high-dose methotrexate will improve the FMH (performance ability scoring system) status of patients with high-grade malignant glioma or diffuse intrinsic pontine glioma as compared to standard treatment.

4. The consolidation therapy will improve the overall, progression free or event free survival rates as compared to the historical control group.

5. Inclusion of second histologic opinion will help increase the standard of care for all patients in these disease population.

Study Status Information



Study Activation / Registration Date:	12/07/2005

IRB Review and Approval Date:	11/16/2005

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	60 patients per year, 150 patients in total (GPOH referral base)

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) Newly diagnosed CNS tumor.

2) Age: 3-18 years at time of diagnosis.

3) Tumor location : brain or spinal cord.

4) Diagnosis: either histological proven high grade gliomas (glioblastoma [WHO�IV], or anaplastic astrocytoma [WHO�III], or gliosarcoma (WHO�III or �IV), or anaplastic oligo-astrocytoma), or radiological proven diffuse intrinsic pontine glioma as determined by the local institution.

Exclusion Criteria:

1) Poor clinical condition with symptoms of either cardiorespiratory insufficiency requiring medical respiration, or low blood pressure requiring systemic catecholamines, or severe neurological damage comparable to a coma, or tetraplegia without possibility to communicate.

2) Pregnancy.

3) Participation in another experimental treatment study.

4) Pretreatment of the tumor with radiotherapy or chemotherapy. The following medication are not be considered "chemotherapy": therapy with mistletoe, therapy with H15, homeopathy therapy with dilution > D4 and all "alternative medication" without proven efficacy.

5) Hypersensitivity for methotrexate, cisplatinum, vincristine, CCNU, ifosfamide.

6) Second malignancy is only an exclusion criteria when preceding radiotherapy will not allow further radiation of the tumor.

7) Diffuse metastases making craniospinal irradiation necessary.

8) Disseminated metastases or multifocal tumor will be excluded if the field of irradiation includes too much bone marrow to do the intense simultaneous chemotherapy.

Links

Registration Number: NCT00278278
Study Information on Clinical Trials Registry (clinicaltrials.gov)