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Therapy-Optimization Trial and Phase II Study for the Treatment of Relapsed or Refractory of Primitive Neuroectodermal Brain Tumors and Ependymomas in Children and Adolescents


Phase 2/Phase 3
3 Months
30 Years
Open (Enrolling)
Both
Recurrent Brain Tumors, Supratentorial PNETs, Medulloblastomas, Ependymomas

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Trial Information

Therapy-Optimization Trial and Phase II Study for the Treatment of Relapsed or Refractory of Primitive Neuroectodermal Brain Tumors and Ependymomas in Children and Adolescents


Parts of the study:

P-HIT-REZ-2005: a trial for the treatment of relapsed PNETs
(medulloblastomas,supratentorial PNETs)

E-HIT-REZ-2005: a trial for the treatment of relapsed ependymomas (Phase II-Study with
temozolomide)

Phase II-Study: intraventricular therapy with etoposide in neoplastic meningitis in relapsed
PNETs and ependymomas with subarachnoid tumor manifestation (window study)


Inclusion Criteria:



Disease Characteristics

- Histologically confirmed Medulloblastoma, cerebral PNET or Ependymoma

- Refractory or relapsed disease

- Measurable disease by MRI or detection of tumor cells in cerebrospinal fluid
Patients characteristics

- Performance status ECOG ≥ 3 or Karnofsky Status ≥ 40%

- Life expectancy ≥ 8 weeks

Hematological:

- Absolute leukocyte count ≥ 2.0 x 10^9 /l

- Hemoglobin ≥ 10g/dl

- Platelet count ≥ 70 x 10^9/l

Renal:

- Creatinine no greater than 1.5 times UNL

- No overt renal disease

Hepatic:

- Bilirubin less than 2.5 times UNL

- AST and ALT less than 5 times UNL

- No overt hepatic disease

Pulmonary:

- No overt pulmonary disease

Cardiovascular:

- No overt cardiovascular disease

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No uncontrolled infection Prior concurrent therapy

- More than 2 weeks since prior systemic chemotherapy

- More than 4 weeks since prior radiotherapy

- No other concurrent anticancer or experimental drugs Examinations required

- Examination of lumbar CSF

- Cranial and spinal MRI within 14 days prior to start of treatment

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

P-HIT-REZ 2005 study: two Chemotherapy-arms: progression-free survival from therapy start and response evaluation after the fourth therapy course

Outcome Time Frame:

10 years

Safety Issue:

No

Principal Investigator

Gudrun Fleischhack, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Pediatric Hematology & Oncology, Pediatrics III, University Children's Hospital Essen

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

EUDRACT 2005-002618-40

NCT ID:

NCT00749723

Start Date:

February 2006

Completion Date:

January 2016

Related Keywords:

  • Recurrent Brain Tumors
  • Supratentorial PNETs
  • Medulloblastomas
  • Ependymomas
  • brain tumor
  • relapse
  • children
  • etoposide
  • intraventricular
  • temozolomide
  • Brain Neoplasms
  • Ependymoma
  • Medulloblastoma
  • Neuroectodermal Tumors, Primitive

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