NOA -05

Prospective, multicentre, single-armed, non-randomized Phase II trial

Inclusion criteria

• Histologically confirmed (focal) astrocytoma WHO Grade II or III, oligoastrocytoma WHO II or III, oligodendroglioma WHO II or III or glioblastoma medulloblastoma (+/- postop. residual tumor, M0) and medulloblastoma respectively
• Karnofsky-Index > 50 %
• Age>18 Years

Status of the study: follow up (status 10/2009)

In the course of the NOA-05 study patients are treated with a PC-chemotherapy after the primary diagnosis. This chemotherapy consists of the two substances, Procarbazin (Natulan®) and CCNU/Lomustin (Cecenu®). In case of a progressive tumor growth patients get radiation therapy.

Contact person: Prof. Dr. med. A. Melms

NOA-07

Multicentre pilot study for the therapy of medulloblastoma of the adulthood

Inclusion criteria

• Age>18 Years
• Medulloblastoma (+/- postop. residual tumor, M0) or medulloblastoma respectively
• Primary diagnosis of the tumor
• No previous chemo- or radiation therapy
• Karnofsky-Index ≥ 70%

Status of the study: recruted (status 10/2009)

Radiation therapy:

Without brain metastasis for 4.4 weeks, afterwards accretion of the posterior cranial fossa for 2.1 weeks. In patients with metastasis: additional accretion of the cerebral metastasis with 11 fractions, patients with spinal metastasis with 8 fractions, respectively.

Chemotherapy:

Vincristin during the radiation period, lateron weekly maintenance chemotherapy consisting of CCNU, Cisplatin and Vincristin

Contact person: Dr. G. Henke

NOA-08

Prospective, multicentre, two-armed, randomized phase III trial

Inclusion criteria

• Age: >64 years
• Histologically confirmed primary diagnosis of a glioblastoma or anaplastic astrocytoma
• Primary diagnosis of the tumor
• No previous chemo- or radiation therapy
• Karnofsky-Index ≥ 70%

Status of the study: recruted (status 10/2009)

The NOA-08 study analyzes (prospectively and randomized) the following question: Is a temozolomide based chemotherapy in over 64 year old patients with malignant glioblastoma equivalent to a radiation therapy of the enhanced tumour region? Also, the quality of life and prognostic molecular parameters as well as resistance factors (MGMT) are determined.

Contact person: Dr. C. Braun

OSAG-Trial

Prospective, multicentre, two-armed, randomized phase II trial

Inclusion criteria

• Age: 18-70 Years
• Histologically confirmed primary diagnosis of a glioblastoma
• No previous chemo- or radiation therapy
• Karnofsky-Index ≥ 70%

Status of the study: recruted (status 10/2009)

The effectivity of Nimotuzumab in the treatment of glioblastoma is determined. Arm A consists of the standard glioblastoma therapy (radiation plus temodzolomide) and the additional infusion of Nimotuzumab (Theraloc®). In arm B patients are only treated with the current standard therapy.

Contact person: Prof. Dr. med. A. Melms

EORTC 22033 -26033

Prospective, international, multicentre, two-armed, non- randomized phase III trial

Inclusion criteria

• Histologically confirmed low-grade glioma of the following type:
• Astrocytoma (gemistocytic, fibrillary, protoplasmatic)
• Oligoastrocytoma
• Oligodendroglioma
• WHO Grade II
• Supratentorial localization
• RTOG 0-3
• No candidate for exclusively surgical therapy

Status of the study: recruted (status 10/2009)

At first, this trial registers patients with a histologically assured diagnosis in one observation arm. In the case of progression, patients are randomized in one arm of either radiation therapy or chemotherapy. The effectivity of radiation therapy versus temozolomide is tested. Temozolomide is given on 21 days per month.

Contact person: Dr. C. Braun

EORTC 26053 -22054 (CATNON Intergroup Trial)

Prospective, international, multicentre, four-armed, randomized phase III trial

Inclusion criteria

• Age: >18 years
• Histologically confirmed anaplastic glioma of one of the following types:
• Astrocytoma
• Oligoastrocytoma
• Oligodendroglioma
• Primary diagnosis of the tumor
• Absence of a 1p/19q deletion
• No previous chemo- or radiation therapy
• Karnofsky-Index ≥ 70%

Status of the trial: recruted (status 10/2009)

This trial analyzes the effectiveness of radiation therapy versus chemotherapy and the combination of chemo- and radiation therapy in anaplastic gliomas. Arm A: radiation therapy alone (33 fractions 5 days per week). Arm B: radiation therapy and concomitant chemotherapy using temozolomide. Arm C: radiation therapy followed by temozolomide up to one year. Arm D: radiation therapy, concomitant temozolomide treatment followed by temozolomide up to one year.

Ansprechpartner: Dr. C. Braun

Glarius Trial

Prospective, multicentre, two-armed, randomized phase II trial

Inclusion criteria

• Age: >18 years
• Histologically confirmed diagnosis of a glioblastoma
• No previous chemo- or radiation therapy
• Karnofsky-Index ≥ 70%
• No contraindication against Avastin

Status of the trial: recruted since 01/10 (status 10/2009)

The Glarius Trial compares the efficiency of Avastin and Irinotecan with the efficiency of the established standard therapies consisting of temozolomide and radiation in patients with primarily diagnosed glioblastoma. Arm A: patients receive Avastin concomitant to radiation therapy. After completion of radiation therapy a combination of Avastin and Irinotecan is applied for six months. Arm B: patients recieve the established standard therapy.

Contact Person: Dr. C. Braun

AP 12009-G005-Studie

Prospective, randomized, multicentre, two-armed phase II trial

Inclusion criteria

• Age: 18-70 years
• Histologically confirmed diagnosis of an astrocytoma WHO grade III
• The lesion is > 2 cm³ and < 50 cm³
• Supratentorially localized tumor
• Patient with a recurrence or a disease refractory to therapy
• The patient must have received less than two chemotherapies
• Karnofsky-Index > 70%
• Hematological parameter in normal range

Status of the trial: recruted (status 10/2009)

This trial analyzes the influence of TGF-beta2-specific phosphorothioat-antisense-oligodesoxynucleotide (AP 12009) in patients with a recurrent anaplastic astrocytoma. The patients will be randomized into two arms. Arm A receives AP 12009 intratumoral, applied by a catheter and an external pump. In the control arm B the patients receive either temozolomide or BCNU in standard doses. Temozolomide is applied with a dose rate of 150 - 200 mg/m² body surface per day after the schema 5/28 day. BCNU is applied with a dose rate of 150 mg/m² body surface per day every 6 weeks.

Contact person: PD Dr. R. Ritz

Hello-Trial

Prospective, one-armed, bicentre pilot study

Inclusion criteria

• Age: >18 years
• Histologically confirmed diagnosis of an astrocytoma WHO grade III
• Imaging suspicion of a brain tumor (primary manifestation)
• Planned bioptical or cytoreductive operation of the tumor
• Symptomatic (caused by the tumor) seizure disorder
• Karnofsky-Index ≥ 70%
• Pre-menopausal women have to use one of the following methods for contraception: hormonal form of contraception, operative sterilisation, hysterectomia, bilateral excision of the ovarias, vasectomy of the partner, sexual abstinence. Those women are considered "post-menopausal" having amenorrhoe for at least one year and have not received any hormone replacement therapy in the last 5 month.

Status of the trial: recruted (status 10/2009)

This pilot study examines how a standardized peri- and postoperative treatment with Levetiracetam (Keppra®) can be realized in patients with epilepsia caused by the tumor. Further aims are the determination of  the effectiveness of intravenous and oral applied Levetiracetam concerning the prevention of perioperative seizures (from the beginnning of the treatment until 30 days after the operation) in patients with a primary brain tumor and one or more symptomatic seizures previous to the operation. It also determines the safety and tolerance of the intravenous and oral application of Levetiracetam. Additionally the influence of the anti-epileptical therapy on the quality of life will be analyzed.

Contact person: Dr. P. Körtvelyesi