Know Cancer

or
forgot password

A Phase II, Randomized, Open-label, Multi-centre Study of Weekly APG101 + Reirradiation Versus Reirradiation in the Treatment of Patients With First or Second Progression of Glioblastoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma Multiforme

Thank you

Trial Information

A Phase II, Randomized, Open-label, Multi-centre Study of Weekly APG101 + Reirradiation Versus Reirradiation in the Treatment of Patients With First or Second Progression of Glioblastoma


In this phase II trial, patients with a recurrence / progression of glioblastoma (first or
second progression) either not being eligible for tumour resection or having macroscopic
residual tumour after resection of the recurrence can be included (tumor size must 1-4 cm in
T1-weighted MRI). They must be candidates for a re-irradiation and will then be randomized
in a 1:2 ratio to re-irradiation alone or re-irradiation + 400mg APG101 as a weekly
intravenous infusion.

Radiotherapy (RT) is considered standard of care and not a study procedure. As prior
therapies, a first radiotherapy (maximal dose of 60 Gy; at least 8 months since the end of
preirradiation), a prior surgery (at least for histology) and at least one
Temozolomide-containing chemotherapy are mandatory; patients with prior treatment with
bevacizumab, iodine seeds and/or brachytherapy are not eligible. The patients' steroid dose
must be stable or decreasing upon inclusion.

The number of patients to be included in this study is up to 83 (depending on the
statistical 2-step SIMON design).

Primary objective: 6 months rate of progression free survival (PFS6). Subjects can
participate in this study as long as a clinical benefit is considered by the treating
physician.

MRI tumour imaging will be carried out every 6 weeks.


Inclusion Criteria:



- Male and female patients with a recurrence / progression of glioblastoma either not
being eligible for tumour resection or having macroscopic residual tumour after
resection of the recurrence

- Diagnosis of glioblastoma must be proven histologically and progress must be
documented by MRI. MRI images must not be older than 2 weeks before first
dosing/start of RT

- Not more than two prior therapy regimens including one or two resections, one or two
chemotherapies of which one must have been TMZ-containing and one radiotherapy (RT)
for the brain tumour

- Previous irradiation therapy of the primary tumour with a maximal dose of 60 Gy; at
least 8 months since the end of preirradiation

- Candidate for reirradiation with recurrent tumour visible on MRI-T1 (Gd) and with the
largest diameter measuring 1 cm to 4 cm

- Informed consent

- Age at least 18 years, smoking or non-smoking, of any ethnic origin

- Karnofsky performance index (KPI) ≥ 60%

- Neutrophile counts > 1500/μl / Platelet counts > 80.000/μl / Haemoglobin > 10 g/dl /
Serum creatinine < 1.5-fold upper normal range / Bilirubin, AST or ALT < 2,5-fold
upper normal range unless attributed to anticonvulsants / Alkaline phosphatase <
2,5-fold upper normal range

- Adequate contraception

- Stable or decreasing treatment with steroids within 5 days before treatment start

Exclusion Criteria:

- More than one RT of brain, prior first radiotherapy with more than 60 Gy

- Cumulative total dose on the optical chiasm >54 Gy for 2 Gy/fraction, α/β=2

- Prior treatment with bevacizumab, iodine seeds and/or brachytherapy

- Unable to undergo MRI

- Past medical history of diseases with poor prognosis according to the judgement of
the Investigator, e.g. severe coronary heart disease, severe diabetes, immune
deficiency, residual deficits after stroke, severe mental retardation

- HIV or hepatitis infection

- Pregnancy or breast feeding

- Treatment within any other clinical trial parallel to the treatment phase of the
current study or within 30 days before inclusion

- Known active coronary artery disease, significant cardiac arrhythmias or severe
congestive heart failure (NYHA class III - IV)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

6 months rate of progression free survival (PFS6)

Outcome Time Frame:

6 month

Safety Issue:

No

Principal Investigator

Wolfgang Wick, MD

Investigator Role:

Study Director

Investigator Affiliation:

University Hospital Heidelberg, Dept. of Neurooncology, Germany

Authority:

Germany: Paul-Ehrlich-Institut

Study ID:

APG101_CD_002

NCT ID:

NCT01071837

Start Date:

December 2009

Completion Date:

December 2013

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma Multiforme
  • Glioblastoma

Name

Location