Protocol Number: 06-C-0089

Title:

A Phase II Trial of 06-Benzylguanine and Temozolomide in Pediatric Patients with Recurrent or Progressive High-Grade Gliomas and Recurrent or Progressive Brainstem Tumors

Number:

06-C-0089

Summary:

Background:

Temozolomide kills cancer cells by damaging their genetic material (DNA). The drug is approved for treating certain adult brain tumors, but no study has been able to show that it works in children with the same type of tumor.

O(6)-BG inactivates a protein called AGT that cancer cells use to repair damage from temozolomide.

Combining temozolomide and O(6)-BG may make temozolomide more effective in killing tumor cells.

Objectives:

To find out how well O6-BG and temozolomide work together in treating brain tumors.

To learn more about the side effects that may occur when O(6)-BG is given with temozolomide.

To learn more about how tumors respond to combined treatment with O(6)-BG and temozolomide.

Eligibility:

Patients 21 or younger with a high-grade glioma or brainstem tumor who have received standard therapy, including radiation therapy if that is standard for patient age, and who have had no more than two recurrences or progressions.

Design:

Chemotherapy: Study drugs are given once a day for 5 consecutive days every 4 weeks. O(6)-BG is infused into a vein over one hour; 30 minutes later, temozolomide is given by mouth. Patients may receive up to 12 treatment cycles on this study.

Blood tests: Routine blood tests are done twice a week during cycle 1, then once a week in future courses.

Routine physical examination before every cycle.

Pregnancy test every cycle in women who can bear children.

Brain magnetic resonance imaging (MRI) before courses 3, 5, 7, 9 and 11.

Spine MRI before courses 3, 5, 7, 9 and 11 (if necessary).

Magnetic resonance spectroscopy and magnetic resonance perfusion/diffusion scans for research purposes before courses 3, 5, 7, 9 and 11.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: Completed Study; data analyses ongoing

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Brain

Malignant

Astrocytoma

Glioblastoma

Pontine

Recruitment Keyword(s):

Glioma

Brain Tumor

Brainstem Tumor

Astrocytoma

Glioblastoma

Condition(s):

Glioma

Brainstem Neoplasms

Investigational Drug(s):

06-Benzylguanine

Investigational Device(s):

None

Interventions:

Drug: 06-Benzylguanine

Drug: Temozolomide

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Lashford LS, Thiesse P, Jouvet A, Jaspan T, Couanet D, Griffiths PD, Doz F, Ironside J, Robson K, Hobson R, Dugan M, Pearson AD, Vassal G, Frappaz D; a United Kingdom Children's Cancer Study Group and French Society for Pediatric Oncology Intergroup Study. Temozolomide in malignant gliomas of childhood: a United Kingdom Children's Cancer Study Group and French Society for Pediatric Oncology Intergroup Study. J Clin Oncol. 2002 Dec 15;20(24):4684-91.

Panitch HS, Berg BO. Brain stem tumors of childhood and adolescence. Am J Dis Child. 1970 Jun;119(6):465-72. No abstract available.

Packer RJ, Nicholson HS, Vezina LG, Johnson DL. Brainstem gliomas. Neurosurg Clin N Am. 1992 Oct;3(4):863-79.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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