Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003778

Trial Description

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Title

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

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Trial Acronym

HIT-REZ-2005

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URL of the Trial

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Brief Summary in Lay Language

The purpose of this study is to improve overall survival while maintaining a good quality of
life in pediatric patients with refractory or recurrent brain tumors (medulloblastomas,
supratentorial PNETs, ependymomas WHO grade II and III). Response to different chemotherapy
options (intravenous versus oral chemotherapy, intraventricular chemotherapy) as part of a
multimodal therapy will be assessed. Progression-free, overall survival and toxicity will be
evaluated additionally.

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Brief Summary in Scientific Language

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)

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Organizational Data

  •   DRKS00003778
  •   2012/05/11
  •   2008/09/05
  •   yes
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Secondary IDs

  •   2005-002618-40 
  •   NCT00749723  (ClinicalTrials.gov)
  •   EUDRACT 2005-002618-40  (University Hospital, Bonn)
  •   EC-105/05 
  •   BfArM-4030755 
  •   DKS 2006.01, DK 2008.17 
  •   4030755 
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Health Condition or Problem studied

  •   Recurrent Brain Tumors
  •   Supratentorial PNETs
  •   Medulloblastomas
  •   Ependymomas
  •   C71 -  Malignant neoplasm of brain
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Interventions/Observational Groups

  •   Drug: carboplatin
  •   Drug: etoposide
  •   Drug: temozolomide
  •   Drug: thiotepa, carboplatin, etoposide
  •   Drug: temozolomide, thiotepa
  •   Procedure: autologous stem cell transplantation
  •   Drug: etoposide
  •   Drug: trofosfamide/etoposide
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Treatment
  •   Crossover
  •   II-III
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Primary Outcome

- P-HIT-REZ 2005 study: two Chemotherapy-arms: progression-free survival from therapy start and response evaluation after the fourth therapy course; time frame: 10 years
- E-HIT-REZ 2005 study (Phase II Study "Oral chemotherapy with temozolomide"): Evaluation of response rate to the 60-days oral chemotherapy with temozolomide; time frame: 2 months
- Phase II study "Intraventricular therapy with etoposide": Evaluation of response rate to the 5-week intraventricular therapy with etoposide; time frame: 6 weeks

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Secondary Outcome

- P-HIT-REZ 2005 study: two Chemotherapy-arms: overall survival from start of therapy; time frame: 10 years
- E-HIT-REZ 2005 study: Chemotherapy-arm: progression-free survival from start of therapy; time frame: 10 years
- E-HIT-REZ 2005 study: Chemotherapy-arm: overall survival from start of therapy; time frame: 10 years
- E-HIT-REZ 2005 study: Chemotherapy-arm: toxicity rate (CTC); time frame: 10 years
- Phase II study "Intraventricular therapy with etoposide": toxicity rate (CTC); time frame: 8 years
- P-HIT-REZ 2005 study: two Chemotherapy-arms: toxicity rate (CTC) in both arms; time frame: 8 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

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  •   2006/02/27
  •   160
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   3   Months
  •   30   Years
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Additional Inclusion Criteria

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

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Exclusion Criteria

[---]*

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Addresses

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    • University Hospital, Bonn
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    • Department of Pediatric Hematology & Oncology, Pediatrics III, University Children's Hospital Essen
    • Gudrun Fleischhack, MD 
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    • Department of Pediatric Hematology & Oncology, Pediatrics III, University Children's Hospital Essen
    • Gudrun Fleischhack, MD 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   68
  •   2013/10/30
* This entry means the parameter is not applicable or has not been set.