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Recurrent Brain TumorsPhase 2/3HIT-REZ-2005NCT00749723

Therapy Optimization Trial for the Treatment of Relapsed or Refractory Brain Tumors in Children

A Phase 2/3 study testing carboplatin, etoposide and temozolomide in people with Recurrent Brain Tumors and Supratentorial PNETs, run by University Hospital, Bonn at 54 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 3 months to 30 years
What is being tested?
carboplatin, etoposide and temozolomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
54 sitesGermany
Study dates
1 Feb 2006to 31 Jan 2016
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 months to 30 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 31Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

54 sites in 1 country.

54 sites in 1 country

Germany54 sites

  • Universitätskinderklinik Aachen

    Aachen, 52074

  • Klinikum Augsburg, Klinik für Kinder- und Jugendmedizin

    Augsburg, 86156

  • Helios Klinikum Berlin-Buch, Klinik für Kinderheilkunde und Jugendmedizin

    Berlin, 13125

  • Charité Klinikum Campus Virchow, Kinderklinik

    Berlin, 13353

  • Klinik ür Kinder- und Jugendmedizin in Bethel

    Bielefeld, 33617

  • Universitätskinderklinik Bonn

    Bonn, 53113

  • Städtisches Klinikum Braunschweig, Kinderklinik

    Braunschweig, 38118

  • Klinikum Bremen-Mitte

    Bremen, 28177

  • Universitätskinderklinik Köln

    Cologne, 50924

  • Carl-Thiele-Klinikum Cottbus, Zentrum für Kinderheilkunde

    Cottbus, 03048

  • Vestische Kinder- und Jugendklinik Datteln

    Datteln, 45711

  • Klinikum Dortmund, Klinik für Kinder- und Jugendmedizin

    Dortmund, 44137

  • Universitätsklinikum Dresden, Kinderklinik

    Dresden, 01307

  • Klinikum Duisburg, Klinik für Kinder-und Jugendmedizin

    Duisburg, 47055

  • Universitätskinderklinik Düsseldorf

    Düsseldorf, 40225

  • Helios Klinikum Erfurt, Zentrum für Kinderheilkunde

    Erfurt, 99089

  • Universitätskinderklinik Erlangen

    Erlangen, 91054

  • Universitätskinderklinik Essen

    Essen, 45122

  • Klinikum der Wolfgang Goethe Universität, Klinik für Kinderheilkunde

    Frankfurt am Main, 60590

  • Universitätskinderklinik Freiburg

    Freiburg im Breisgau, 79106

  • Universitätsklinikum Gießen und Marburg, Zentrum für Kinderheilkunde

    Giessen, 35385

  • Universitätskinderklinik Göttingen

    Göttingen, 37075

  • Universitätskinderklinik Greifswald

    Greifswald, 17475

  • Martin-Luther-Universität Halle Wittenberg

    Halle, 06120

  • Universitätskinderklinik Hamburg-Eppendorf

    Hamburg, 20246

  • Medizinische Hochschule, Zentrum für Kinderheilkunde

    Hanover, 30625

  • Universitätskinderklinik Heidelberg

    Heidelberg, 69120

  • SLK Kinderklinik Heilbronn

    Heilbronn, 74078

  • Gemeinschaftskrankenhaus Herdecke, Kinderklinik

    Herdecke, 58313

  • Universitätskinderklinik

    Homburg/Saar, 66421

  • Friedrich Schiller Universität, Klinik für Kinder-und Jugendmedizin

    Jena, 07745

  • Städtisches Krankenhaus, Klinik für Kinder- und Jugendmedizin

    Karlsruhe, 76133

  • Klinikum Kassel, Kinderklinik

    Kassel, 34125

  • UKSH, Campus Kiel, Klinik für Allg. Pädiatrie

    Kiel, 24105

  • Städtisches Klinikum Kemperhof, Klinik für Kinder- und Jugendmedizin

    Koblenz, 56073

  • Universitätskinderklinik Leipzig

    Leipzig, 04317

  • Universitätskinderklinik Lübeck

    Lübeck, 23538

  • Otto-von-Guericke-Universität, Zentrum für Kinderheilkunde

    Magdeburg, 39120

  • Universitätskinderklinik Mainz

    Mainz, 55131

  • Universitätskinderklinik Mannheim

    Mannheim, 68167

  • Universitätskinderklinik Marburg

    Marburg, 35043

  • Klinikum Minden III, Klinik für Kinder-und Jugendheilkunde

    Minden, 32432

  • Dr. von Haunersches Kinderspital

    München, 80337

  • Städtisches Krankenhaus München-Schwabing, Kinderklinik der TU München

    München, 80804

  • Universitätskinderklinik Münster

    Münster, 48129

  • Cnopf'sche Kinderklinik

    Nuremberg, 90419

  • Klinikum Oldenburg, Zentrum für Kinder-und Jugendmedizin

    Oldenburg, 26131

  • Universitäts-Kinderklinik

    Regensburg, 93042

  • Universitätskinderklinik Rostock

    Rostock, 18057

  • Asklepios Klinik Sankt Augustin GmbH

    Sankt Augustin, 53757

  • Olgahospital-Pädiatrisches Zentrum

    Stuttgart, 70176

  • Universitätskinderklinik Tübingen

    Tübingen, 72076

  • Univeritätsklinikum Ulm, Abteilung Kinder-und Jugendmedizin

    Ulm, 89075

  • Universitätskinderklinik Würzburg

    Würzburg, 97080

Other trials in Germany

About this study

Official 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

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.

Read the detailed description

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)

Being tested
carboplatin, etoposide, temozolomide, thiotepa, carboplatin, etoposide, temozolomide, thiotepa
Keywords
brain tumor, relapse, children, etoposide, intraventricular, temozolomide
Medical subject headings
Brain Neoplasms, Medulloblastoma, Ependymoma, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • carboplatinDrug

    Also called Carboplatin IV

    200 mg/m²/d continuously IV on day 1-4 of each 21-28-day-cycle. Number of cycles: until disease progression, maximum 4 cycles

  • etoposideDrug

    Also called etoposide IV

    100mg/m²/d continuously IV on day 1-4 of each 21-28 day cycle. Number of cycles: until disease progression, maximum 4 cycles

  • temozolomideDrug

    Also called temozolomide orally

    150mg/m²/d p.o. on day 1-5 of a 21-28-day-cycle. Number of cycles: until progression or maximum up to 2 years

  • thiotepa, carboplatin, etoposideDrug

    Also called thiotepa, carboplatin, etoposide IV, high dose

    high dose chemotherapy followed by to autologous stem cell transplantation

  • temozolomide, thiotepaDrug

    Also called temozolomide, thiotepa IV

    high dose chemotherapy followed by autologous stem cell transplantation

  • autologous stem cell transplantationProcedure or surgery

    Also called ASCT

    autologous stem cell transplantation following HD-chemotherapy

  • intraventricular etoposideDrug

    Also called etoposide intra-CSF

    prior to systemic chemotherapy as single agent in patients with neoplastic meningitis, in addition to systemic chemotherapy if proven effective in phase II study, intraventricularly age-dependent daily dose (>3m to <3y 0.7 mg; >3y 1.0 mg) for 5 days every 2 two 4 weeks. Number of cycles: at least 3 courses, maximum up to 2 years

  • trofosfamide, etoposideDrug

    Also called trofosfamide, etoposide orally

    maintenance therapy: trofosfamide and etoposide: 100 mg/m²/d and 25 mg/m²/d, respectively, for 21 days every 4 weeks. Number of cycles: until progression or maximum up to 2 years

Study groups in NCT00749723
Study groupRoleWhat they receive
1: P-HIT-REZ 2005Experimentalintravenous chemotherapy with carboplatin/etoposide,followed by * high dose chemotherapy with thiotepa, carboplatin, etoposide and autologous stem cell transplantation if patient have achieved a complete remission or * maintenance therapy with oral trofosfamide, etoposide
Receives: Drug: carboplatin; Drug: etoposide; Drug: thiotepa, carboplatin, etoposide; Procedure: autologous stem cell transplantation; Drug: intraventricular etoposide; Drug: trofosfamide, etoposide
2: P-HIT-REZ 2005Experimentaloral chemotherapy with temozolomide, followed by * high dose chemotherapy with temozolomide, thiotepa and autologous stem cell transplantation if patient have achieved a complete remission * maintenance therapy with oral temozolomide or in case of progression with oral trofosfamide, etoposide
Receives: Drug: temozolomide; Drug: temozolomide, thiotepa; Procedure: autologous stem cell transplantation; Drug: intraventricular etoposide
3: E-HIT-REZ 2005ExperimentalPhase II: oral chemotherapy with temozolomide after progression oral trofosfamide, etoposide
Receives: Drug: temozolomide; Drug: intraventricular etoposide; Drug: trofosfamide, etoposide
Intraventricular EtoposideExperimentalPhase II, intraventricular chemotherapy with etoposide
Receives: Drug: intraventricular etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. P-HIT-REZ 2005 study: two Chemotherapy-arms: response evaluation after the fourth therapy course

    determination of objective repsonse rate (CR+PR)

    Measured: 4 months for each patient (8 years for the whole study population)

  2. E-HIT-REZ 2005 study (Phase II Study "Oral chemotherapy with temozolomide"): Evaluation of response rate to the 60-days oral chemotherapy with temozolomide

    determination of objective repsonse rate (CR+PR/all patients)

    Measured: 2 months for each patient (8 years for the whole study population)

  3. Phase II study "Intraventricular therapy with etoposide": Evaluation of response rate to the 5-week intraventricular therapy with etoposide

    disease stabilization rate (CR+PR+SD/all patients)

    Measured: 6 weeks for each patient (8 years for the whole study population)

Secondary outcomes (5)

  1. P-HIT-REZ 2005 study: two Chemotherapy-arms: PFS and OS from start of therapy

    progression free and overall survival from start of therapy until PD, last follow up or death, respectively

    Measured: 10 years

  2. P-HIT-REZ 2005 study: two Chemotherapy-arms: toxicity rate (CTC) in both arms

    rate of adverse events of CTC°3 or CTC°4 according to CTCAE v3.0

    Measured: 8 years

  3. E-HIT-REZ 2005 study: Chemotherapy-arm: PFS and OS from start of therapy

    progression free and overall survival from start of therapy until PD, last follow up or death, respectively

    Measured: 10 years

  4. E-HIT-REZ 2005 study: Chemotherapy-arm: toxicity rate (CTC)

    progression free and overall survival from start of therapy until PD, last follow up or death, respectively

    Measured: 10 years

  5. Phase II study "Intraventricular therapy with etoposide": toxicity rate (CTC)

    rate of adverse events of CTC°1-4 according to CTCAE v3.0

    Measured: 8 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2008 (estimated)
  2. Study start1 Feb 2006
  3. Primary completion31 Jan 2015
  4. Study completion31 Jan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00749723
Sponsor's protocol ID
EUDRACT 2005-002618-40
Other IDs
BfArM-4030755, EC-105/05, DKS 2006.01, 2008.17, 2012.03
Acronym
HIT-REZ-2005
Status last verified
Jul 2018
First submitted
5 Sep 2008
Last updated
20 Jul 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing carboplatin, etoposide and temozolomide in people with Recurrent Brain Tumors and Supratentorial PNETs, run by University Hospital, Bonn at 54 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 54 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

P-HIT-REZ 2005 study: two Chemotherapy-arms: response evaluation after the fourth therapy course (time frame: 4 months for each patient (8 years for the whole study population)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00749723.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.

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