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Astrocytoma clinical trials

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NCT ID: NCT00761280 Terminated - Glioblastoma Clinical Trials

Efficacy and Safety of AP 12009 in Patients With Recurrent or Refractory Anaplastic Astrocytoma or Secondary Glioblastoma

SAPPHIRE
Start date: December 2008
Phase: Phase 3
Study type: Interventional

In this multinational Phase III study the efficacy and safety of 10 µM AP 12009 is compared to standard chemotherapy (temozolomide or BCNU or CCNU) in adult patients with confirmed recurrent or refractory anaplastic astrocytoma (WHO grade III) or secondary glioblastoma (WHO grade IV).

NCT ID: NCT00751270 Completed - Clinical trials for Glioblastoma Multiforme

Phase 1b Study of AdV-tk + Valacyclovir Combined With Radiation Therapy for Malignant Gliomas

BrTK01
Start date: November 2005
Phase: Phase 1
Study type: Interventional

This phase I study evaluated a Gene Mediated Cytotoxic Immunotherapy approach for malignant gliomas, including glioblastoma multiforme and anaplastic astrocytoma. The purpose of this study was to assess the safety and feasibility of delivering an experimental approach called GliAtak which uses AdV-tk, an adenoviral vector containing the Herpes Simplex thymidine kinase gene, plus an oral anti-herpetic prodrug, valacyclovir, in combination with standard of care radiation.

NCT ID: NCT00734864 Withdrawn - Glioma Clinical Trials

Ph. I Dasatinib/Protracted Temozolomide in Recurrent Malignant Glioma

Start date: June 2009
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of dasatinib when combined with protracted, daily temozolomide (TMZ). Secondary objectives are: To further evaluate the safety and tolerability of dasatinib plus protracted, daily TMZ; 2. To evaluate the pharmacokinetics of dasatinib when administered with protracted, daily TMZ among recurrent malignant glioma patients who are on and not on CYP-3A enzyme inducing anti-epileptic drugs (EIAEDs); 3. To evaluate for anti-tumor activity with this regimen in this patient population.

NCT ID: NCT00734682 Completed - Glioblastoma Clinical Trials

A Phase I Trial of Nanoliposomal CPT-11 (NL CPT-11) in Patients With Recurrent High-Grade Gliomas

Start date: August 2008
Phase: Phase 1
Study type: Interventional

This is a Phase I study of Nanoliposomal CPT-11 in patients with Recurrent high-grade gliomas. Patients must have a histologically proven intracranial malignant glioma, which includes glioblastoma multiforme (GBM), gliosarcoma (GS), anaplastic astrocytoma (AA), anaplastic oligodendroglioma (AO), anaplastic mixed oligoastrocytoma (AMO), or malignant astrocytoma NOS (not otherwise specified). Patients who are wild type or heterozygous for the UGT1A1*28 gene will received Nanoliposomal CPT-11. The total anticipated accrual will be approximately 36 patients (depending upon the actual MTD). The investigators hypothesis is that this new formulation of CPT-11 will increase survival over that seen in historical controls who have recurrent gliomas because CPT-11 will be encapsulated in a liposome nanoparticle, which has been seen to reduce toxicities from the drug.

NCT ID: NCT00723827 Completed - Glioblastoma Clinical Trials

Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2)

Start date: March 2008
Phase: N/A
Study type: Observational

The purpose of this surveillance is to evaluate the postmarketing safety and efficacy of Temodal capsule (temozolomide) under actual conditions of use, and to understand some of the following points that are in question and doubt: - Incidence of adverse events under actual conditions of use (Serious and Nonserious Adverse Events); - Adverse Drug Reactions not shown in the directions for use (will be stated as Unexpected Adverse Reaction); - Adverse Event caused by misuse, abuse, or drug interactions; - Other information concerned with safety or efficacy.

NCT ID: NCT00717210 Completed - Clinical trials for Anaplastic Astrocytoma

Randomized Phase III Study of Sequential Radiochemotherapy of Anaplastic Glioma With PCV or Temozolomide

NOA-04
Start date: June 1999
Phase: Phase 3
Study type: Interventional

Background: The optimal treatment of anaplastic gliomas is controversial. Standard of care in most centers is still radiotherapy. This phase III study compared the efficacy and safety of radiotherapy vs chemotherapy in patients (pts) with newly-diagnosed, supratentorial gliomas of WHO grade III. Methods: Pts were randomized 2:1:1 between June 1999 and February 2005 in 34 German centers to receive (i) a 6-week course of radiotherapy (1,8-2 Gy fractions, total dose 54-60 Gy) or (ii) four 6-week cycles of CCNU at 110 mg mg/m2 on day 1, vincristine at 2 mg on days 8 and 29 and procarbazine at 60 mg/m2 on days 8-21 or eight 4-week cycles of 200 mg/m2 temozolomide on days 1-5. Treatment was stopped prematurely at disease progression or occurrence of unacceptable toxicity. At this time or at disease progression, treatment in the radiotherapy group was continued with one of the chemotherapies (1:1 randomization) and with radiotherapy in both chemotherapy groups. The primary endpoint was time-to-treatment-failure (TTF) defined as progression after radiotherapy and one chemotherapy in either sequence, or any time before if further therapy could not be employed. Assuming a 50% improvement in TTF of starting with chemotherapy, 318 pts were to be enrolled to provide 80% power to achieve statistical significance at a one-sided level of 0.05.

NCT ID: NCT00705198 Completed - Glioma Clinical Trials

Temozolomide All-Case-Registered Surveillance (Designated Drug Use Investigation)(Study P05062)

Start date: September 2006
Phase: N/A
Study type: Observational

The purpose of this study is to confirm the safety and efficacy of temozolomide in patients with newly diagnosed malignant glioma (concomitant with radiotherapy and then as monotherapy) and relapsed malignant glioma (as monotherapy) when used in the daily medical practices. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

NCT ID: NCT00683761 Active, not recruiting - Clinical trials for Glioblastoma Multiforme

A Study of 131I-TM601 in Adults With Recurrent Malignant Glioma

Start date: August 2008
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of 131I-TM601 in the treatment of adult patients with progressive or recurrent malignant gliomas.

NCT ID: NCT00679354 Completed - Clinical trials for Recurrent Childhood Cerebellar Astrocytoma

Cilengitide in Treating Younger Patients With Recurrent or Progressive High-Grade Glioma That Has Not Responded to Standard Therapy

Start date: June 2008
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well cilengitide works in treating younger patients with recurrent or progressive high-grade glioma that has not responded to standard therapy. Cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor.

NCT ID: NCT00667394 Completed - Glioblastoma Clinical Trials

Tandutinib Plus Bevacizumab to Treat Recurrent Brain Tumors

Start date: April 2008
Phase: Phase 2
Study type: Interventional

Background: In order to survive, brain tumors must have a network of blood vessels to supply it with oxygen and nutrients. The tumors produce substances that enable new blood vessels to form. Tandutinib and Bevacizumab are experimental drugs that may prevent new blood vessel formation and thereby slow or stop tumor growth in the brain. Objectives: To determine the safety and side effects of Tandutinib in combination with Bevacizumab in patients with brain tumors. To evaluate the response of brain tumors to treatment with Tandutinib and Bevacizumab. Eligibility: Patients 18 years of age and older with a malignant brain tumor for whom standard treatments (surgery, radiation and chemotherapy) are no longer effective. Design: Patients receive treatment in 4-week cycles as follows: Tandutinib by mouth twice a day every day and intravenous (through a vein) infusions of Bevacizumab over 90 minutes (or less if well tolerated) every 2 weeks. Treatment may continue for up to 1 year, and possibly longer, as long as there are no signs of tumor growth or serious treatment side effects. Patients are evaluated with magnetic resonance imaging (MRI), computed tomography (CT) and positron emission tomography (PET) scans before starting treatment and then periodically to determine the response to treatment. Patients have physical and neurological examinations every 4 weeks and blood tests every 2 weeks. They complete quality of life questionnaires every 4 weeks.