The Brain Tumor Cooperative Group (BTCG) has performed a series of controlled prospective randomized trials in patients with malignant gliomas, which have established the state-of-the-art of the multimodality treatment of this disease consisting of extensive surgical resection, high-dose radiation therapy (RT) and adjuvant chemotherapy. It is proposed to continue these studies as follows: I. To increase good-quality survival by performing Phase III and Phase II clinical trials. To perform a new Phase III trial based on the concept of Induction of Remission, which will utilize interstitial radiation therapy as part of the RT modality. This Trial (87-01) randomizes newly diagnosed patients to (a) receive postoperative temporary 1241 seed implantation in the residual tumor bed, followed by standard external beam RT plus IV BCNU, or (b) to receive external RT plus BCNU, without the seed implantation. The trail will test the value of adding interstitial radiation to the previously established best available therapy regimen. The Phase II, Scheme A trail randomizes previously resected and radiated Nonprogressive patients and Progressive patients without prior chemotherapy to (a) intracaratid (IC) Cisplatin or (b) IV PCNU. The Phase II, Scheme B trial tests the value of intramuscular interferon in the treatment of Progressive patients who have failed initial therapy, including chemotherapy. To test a new system of RT quality control based on CT scan measurements. II. To plan and perform a new Phase III trial (87- 30) in patients with low-grade gliomas to determine the value of RT along with surgical resection in the treatment of this disease. III. To investigate the tumor-host biology of human gliomas, including their presentation and evolution in relationship to CT and MRI scans, prognostic variables and histopathological changes over time. IV. To study acute and long-term consequences of therapy including early and late RT/chemotherapy neurological effects assessed by CT, MRI, clinical, psychometric and pathological changes, and non-neurological effects.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10CA036047-07
Application #
3557918
Study Section
Cancer Clinical Investigation Review Committee (CCI)
Project Start
1983-12-01
Project End
1992-11-30
Budget Start
1990-12-01
Budget End
1991-11-30
Support Year
7
Fiscal Year
1991
Total Cost
Indirect Cost
Name
St. Joseph's Hosp/Medical Center (Phoenix)
Department
Type
DUNS #
City
Phoenix
State
AZ
Country
United States
Zip Code
85013
Selker, R G; Eddy, M S; Deutsch, M et al. (1995) On the development of an interstitial radiation protocol for a multicenter consortium. Experience with permanent low-dose rate and temporary high-dose rate 125I implants in 'failed' and 'newly diagnosed' glioblastoma patients: quality assurance methodolog J Neurooncol 26:141-55
Hiesiger, E M; Green, S B; Shapiro, W R et al. (1995) Results of a randomized trial comparing intra-arterial cisplatin and intravenous PCNU for the treatment of primary brain tumors in adults: Brain Tumor Cooperative Group trial 8420A. J Neurooncol 25:143-54
Vertosick Jr, F T; Selker, R G; Randall, M S et al. (1994) A comparison of the relative chemosensitivity of human gliomas to tamoxifen and n-desmethyltamoxifen in vitro. J Neurooncol 19:97-103
Malkin, M G; Green, S B; Byar, D P et al. (1994) Superiority of PCNU over AZQ in the treatment of primary brain tumors: results of a prospective randomized trial (81-20) by the Brain Tumor Study Group. J Neurooncol 22:55-65
Shapiro, W R; Green, S B; Burger, P C et al. (1992) A randomized comparison of intra-arterial versus intravenous BCNU, with or without intravenous 5-fluorouracil, for newly diagnosed patients with malignant glioma. J Neurosurg 76:772-81
Vertosick Jr, F T; Selker, R G; Pollack, I F et al. (1992) The treatment of intracranial malignant gliomas using orally administered tamoxifen therapy: preliminary results in a series of ""failed"" patients. Neurosurgery 30:897-902;discussion 902-3
Adams, B A; Clancey, J K; Eddy, M (1991) Malignant glioma: current treatment perspectives. J Neurosci Nurs 23:15-9
Vertosick Jr, F T; Selker, R G; Arena, V C (1991) Survival of patients with well-differentiated astrocytomas diagnosed in the era of computed tomography. Neurosurgery 28:496-501
Arvay, C A (1991) Clinical trials: bringing research to the bedside. J Neurosci Nurs 23:64-7
Vertosick Jr, F T; Selker, R G (1990) Brain stem and spinal metastases of supratentorial glioblastoma multiforme: a clinical series. Neurosurgery 27:516-21;discussion 521-2

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