Description:

ODM derived from http://clinicaltrials.gov/show/NCT00761280

Link:

http://clinicaltrials.gov/show/NCT00761280

Keywords:
Versions (3) ▾
  1. 12/6/13
  2. 4/16/14
  3. 9/20/21
Uploaded on:

September 20, 2021

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License:
Creative Commons BY 4.0
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Eligibility DRKS00003686 NCT00761280 Anaplastic Astrocytoma

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age 18 Years to 70 Years
The patient has provided written informed consent prior to any study-related procedure.
The patient has a present diagnosis of AA or secondary GBM.
The patient has a measurable lesion (> 1 ccm in volume, central MRI review).
The lesion (or sum of lesions) does not exceed 50 ccm in volume (central MRI review).
The tumor is localized supratentorially (central MRI review).
All patients have recurrent or refractory disease, i.e. disease has progressed after prior surgery and radiotherapy at any time of the disease course or stage. Secondary GBM patients have progressed after a previous diagnosis of A and/or AA.
The patient has not received more than one chemotherapy regimen. Radiation with concomitant chemotherapy, followed by adjuvant chemotherapy, is considered as one chemotherapy regimen.
The patient is eligible for chemotherapy.
The patient is on a maximum dose of 4 mg/day dexamethasone or equivalent doses for other corticosteroids, which has been stable or decreasing for at least 3 weeks prior to Screening.
The patient is male or a non-pregnant, non-lactating female.
Females of childbearing potential must have a negative beta-HCG pregnancy test at Screening.
Females of childbearing potential and males must practice strict birth control.
The patient must have recovered from acute toxicity caused by any previous therapy.
The patient has a life expectancy of at least 3 months.
Karnofsky performance status (assessment scale)
The patient shows adequate organ functions as assessed by the following screening laboratory values:
Adequate renal function determined by serum creatinine and urea < 2 times the upper limit of normal
Adequate liver function with ALT, AST and AP < 3 times the upper limit of normal, and bilirubin < 2.5 mg/dL
INR < 1.5 and aPTT < 1.5 x ULN
Hemoglobin
Platelet count - finding
White Blood Cell Count procedure (WBC)
ANC > 1.5 x 10E9/L (or WBC > 3.0 x 10E9/L)
Exclusion Criteria
Patient unable or not willing to comply with the protocol regulations.
The investigator deems it necessary to surgically (re-)resect the present tumor (NOTE: the patient might still be eligible for randomization at a later timepoint).
Tumor surgery, tumor debulking, or other neurosurgery within 3 months prior to randomization. If a <=48-hour routine post-surgery MRI (in accordance with study specifications) qualifies the patient for study participation, the patient can be randomized 30 ± 7 days post-surgery.
Radiotherapy or stereotactic (gamma knife) radiosurgery within 3 months prior to randomization.
Prior interstitial brachytherapy of the brain with permanent implants. Prior interstitial brachytherapy of the brain with removable implants within 3 months prior to randomization.
Chemotherapy, hormone therapy, or any other therapy with established or suggested anti-tumor effects within 4 weeks (nitrosoureas: 6 weeks) prior to randomization.
Prior anti-TGF-beta 2 targeted therapy.
Screening MRI shows a mass effect caused by the tumor defined as significant compression of the ventricular system and/or a midline shift (>= 3 mm, central MRI review). Compression of the ventricular system and/or a midline shift >= 3 mm only due to the presence of (a) cyst(s) or scarring processes does not exclude an individual from the study.
Participation in another clinical study with another investigational medicinal product within 30 days prior to randomization.
History of a second independent malignant disorder within 5 years, except for carcinoma in situ of the cervix and basal cell carcinoma.
Seizures, poorly controlled
Clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure, unstable angina, or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization.
Known HIV, HBV or HCV infection.
Acute viral, bacterial, or fungal infection.
Acute medical problems that may be considered to become an unacceptable risk, or any conditions, which might be contraindications for starting study treatment.
Presence of high risk for pulmonary toxicities, defined as:
Lung function: vital capacity ≤ 70%
Status following sequential or concomitant thoracic irradiation
Increased risk for a pulmonary toxicity induced by BCNU (Carmustine) or CCNU (Lomustine). Risk factors include smoking, presence of a respiratory condition, pre-existing radiographic pulmonary abnormalities, exposure to agents that cause lung damage.
History of allergies to reagents used in this study.
Drug abuse or extensive use of alcohol.
Clinically relevant psychiatric disorders / legal incapacity or a limited legal capacity.
Concomitant treatment with yellow fever vaccine.

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