patients with medulloblastoma in whom therapy for primary disease (minimum: best possible resection, radiotherapy and one chemotherapy regimen) failed
Conditions
Interventions
Trade Name: Sandostatin 1500 µg/3 ml für Pen
Product Name: Sandostatin 1500µg/3ml für Pen
Product Code: SMS995
Pharmaceutical Form: Injection*
INN or Proposed INN: Octreotid
CAS Number: 83150-76-9
Cur
Sponsors
Medizinische Einrichtungen des Bezirks Oberpfalz GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically confirmed diagnosis of medulloblastoma/PNET WHO grade IV with confirmatory histology (german reference center for neuropathology, Bonn). • Age: 18-70 years. • Karnofsky performance status of at least 70 % • Positive somatostatin receptor status (111In-octreotide scintigraphy). • Measurable lesion (including cysts and/or necrotic areas) with a maximum diameter of 4,5 cm documented by MRI (note: exception for resection defect located within a measured lesion: if volume of defect > 20 % of volume of the respective measured lesion, a maximum diameter of 6,0 cm is allowed). • Lesion (or sum of lesions) does not exceed 50 cm3 in volume. • Standard treatment (1. debulking surgery, 2. craniospinal irradiation [with approx. 35 Gy] + boost to the posterior fossa [total approx. = 50 Gy], 3. Chemotherapy with at least 1 regimen finished. • Prior chemotherapy finished at least 4 weeks prior to study entry. • Adequate hepatic, renal and bone marrow function as defined by the following: total bilirubin 1.5 x 109/L, platelets > 100 x 109/L and Hb >10g/dL. • Female patients of childbearing potential with a negative pregnancy test within 7 days of initiation of study drug dosing. Pregnancy tests will be repeated every 4 weeks at the start of every cycle (to be clarified by CROLLL). Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential who agree to employ an effective barrier method of birth control throughout the study, and for up to 3 months following discontinuation of study drug. • Clinically normal cardiac function without history of ischaemic heart disease in the past 6 months with normal 12 lead ECG and absence of uncontrolled cardiac arrythmias. • Ensured compliance: The patient should be able to cooperate with the protocol regulations and follow-up. • Signed informed consent prior to initiation of any study procedure. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Symptomatic gallstones • Previous or current malignancies at other sites with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma. • Patients receiving EIADs (Patients under EIADS should be switched to no EIADs prior to study entry). • Active infection of HIV, HBV, HCV; clinically significant 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. • History of allergies to reagents used in this study. • Drug abuse or extensive use of alcohol. • Patient has received any other investigational agent within 28 days of first day of study drug dosing. • Patient receive any other somatostatin analogues • Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The general objective is to assess the safety and tolerance of high-dose Sandostatin® LAR® in patients with recurrent medulloblastoma during dose escalation.;Secondary Objective: Key secondary objective is to assess the efficacy of the given regimen. Optimal scheduling of Sandostatin® LAR® will also be addressed. A recommended dose for a phase II-study will be established. In addition to the objectives mentioned above, changes in somatostatin receptor imaging with 111In-octreotide-szintigraphy under therapy with Sandostatin® LAR® will be assessed and correlated with the given dosage under dose escalation.;Primary end point(s): The primary endpoint (safetly and tolerance of high dose Sandostatin LAR in patients with recurrent medulloblastoma) will be based mainly on the frequency of adverse events and on the number of laboratory values that fall outside of pre-determined ranges. | — |
Countries
Germany
Outcome results
None listed