MedulloblastomaPhase 1/2NOA-07NCT01614132
Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults
A Phase 1/2 study testing maintenance chemotherapy (vincristin, cisplatin and CCNU) and Radiotherapy in people with Medulloblastoma, run by University of Regensburg at 15 sites in Germany.
Trial summary
The purpose of this study is to determine whether a combination of a radiochemotherapy (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in adult patients with medulloblastoma is tolerable. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Medulloblastoma
- What is being tested?
- maintenance chemotherapy (vincristin, cisplatin and CCNU) and Radiotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 15 sitesGermany
- Study dates
- Jan 2009to Oct 2018
- Phase
- Phase 1/2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age > 18 years
- medulloblastoma (+/- postoperative residual tumor, M0) or medulloblastoma (+/- postoperative residual tumor, M1-M3) respectively
- primary diagnosis of the tumor
- no previous chemo- or radiation therapy
- Karnofsky-Index ≥ 70%
- WBC ≥ 3000/μl; thrombocytes ≥ 100 000/μl; Hb ≥ 10 g/dl
Show all 12Show fewer
- creatinine =< 1,5 ULN; Bilirubin =< 1,5 ULN; GPT, GOT, AP =< 2,5 ULN
- HIV and hepatitis B/C negative
- no factors / any medical condition affecting patient's compliance
- patient needs to fulfil protocol's requirements
- patient is willing to use highly effective methods of contraception during dosing and for 6 months after the last dose; women of child-bearing potential must have a negative hCG laboratory test at baseline; pregnancy tests must be repeated every 4 weeks
- patient's written consent
Who cannot join
- age < 18 years
- histologically not confirmed Medulloblastoma
- by chemo- or radiotherapy treated recidive tumor
- other cancer (with exception of surgically cured carcinoma in situ of the cervix and non-melanocytic skin tumors)
- hypersensitivity or contraindication against one of the used drugs
- current or planned participation to another clinical trial during this study Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrolment or could interfere with the patient participating in and completing the study
- Any medical condition associated with high medical risk or contraindicated to use chemotherapeutic agents as indicated in current product package insert
- Pregnant or nursing (lactating) women; women or men not willing to use a highly effective methods of contraception
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Germany15 sites
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 10249
Neurologische Universitätsklinik
Bochum, 44892
Universitätsklinikum Bonn
Bonn, 53105
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Medizinische Hochschule Hannover
Hanover, 30625
Universitätsklinikum Heidelberg
Heidelberg, 69120
Universitätsklinikum Leipzig
Leipzig, 04103
Universitätsklinikum Schleswig-Holstein
Lübeck, 23538
Otto-von-Guericke Universität
Magdeburg, 39120
Johannes Gutenberg-Universität Mainz
Mainz, 55131
Universitätsklinikum Münster
Münster, 48149
Universitätsklinikum Regensburg
Regensburg, 93053
Katharinenhospital
Stuttgart, 70174
Universitätsklinikum Tübingen
Tübingen, 72076
Universitätsklinikum Ulm
Ulm, 89081
About this study
Official title: Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults (NOA-07)
The purpose of this study is to determine whether a combination of a radiochemotherapy (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in adult patients with medulloblastoma is tolerable.
Read the detailed description
As medulloblastoma in adult patients are very rare (1.1% of all brain tumors), adults are often treated in the scope of expanded access treatments or within pediatric studies; although, it is not known whether medulloblastomas act in the same way in adulthood and in childhood. This is the first study to investigate the significance of a combination of a radiochemotherapy (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in adult patients with medulloblastoma with the purpose to have a starting point for the development of chemotherapeutical protocols in adults.
- Conditions
- Medulloblastoma
- Being tested
- maintenance chemotherapy (vincristin, cisplatin and CCNU), Radiotherapy
- Keywords
- medulloblastoma, CNS, malignant neoplasm, NOA, neuroectodermal tumor, Vincristin, CCNU, Cisplatin
- Medical subject headings
- Medulloblastoma, Neoplasms, Neuroectodermal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maintenance chemotherapy (vincristin, cisplatin and CCNU)Drug
Also called Vincristin: L01CA02, CCNU: Lomustin L01AD02, cis-platin: L01XA01
maintenance chemotherapy of maximum of 8 cycles á 42 days
RadiotherapyRadiation
Radiotherapy of the partial brain
| Study group | Role | What they receive |
|---|---|---|
| Vincristin, CCNU, cis-platin | Experimental | radiotherapy and concomitant chemotherapy (7 cycles of 7 days):
* 2 mg/m2 vincristin i.v.
* 55,0 Gy Posterior cranial fossa (M0)
* 55,0 Gy Posterior cranial fossa / cerebral metastases + 49,6 Gy spinal metastases (M1-M3)
maintenance chemotherapy (8 cycles of 42 days):
* once at day 1 at each cycle: 70 mg/m2 cis-platin i.v. 75 mg/m2 CCNU oral 2 mg/m2 vincristin i.v.
* once at day 8 and 15 at each cycle: 2 mg/m2 vincristin i.v. Receives: Drug: maintenance chemotherapy (vincristin, cisplatin and CCNU); Radiation: Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
feasibility of the adjuvant chemotherapy
The main objective is the feasibility of the adjuvant chemotherapy which has gained the best results when combined with radiotherapy so far.
The present protocol is primarily to determine the number of interruptions of the maintenance chemotherapy due to toxicity and the kind of toxicity .
Measured: participants will be followed for the duration of chemo therapy, an expected average of 1 year
Secondary outcomes (5)
Number of performable cycles in chemo therapy
It should be determined how many cycles in the maintenance chemotherapy are feasible.
Measured: participants will be followed for the duration of chemo therapy, an expected average of 6 months
3 and 5 years progression-free survival
The 3 and 5-years rate of progression-free survival (pfs) should be determined for adult patients.
Measured: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
event-free survival
The event-free survival (efs) should be determined for adult patients.
Measured: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
overall survival
The overall survival (os) should be determined for adult patients.
Measured: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
course of cognitive performance/QoL
The course of the cognitive performance and the quality of life should be observed.
Measured: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startJan 2009
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MedulloblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Hau, University of Regensburg
- Investigators
- Peter Hau, MD, Principal investigator, Department of Neurology, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614132
- Sponsor's protocol ID
- NOA-07
- Acronym
- NOA-07
- Status last verified
- Mar 2020
- First submitted
- 26 Apr 2012
- Last updated
- 31 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults (NOA-07)
- ClinicalTrials.gov ID
- NCT01614132
- Acronym / sponsor ID
- NOA-07 / NOA-07
- Conditions
- Medulloblastoma
- Keywords
- medulloblastoma, CNS, malignant neoplasm, NOA, neuroectodermal tumor, Vincristin, CCNU, Cisplatin
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a combination of a radiochemotherapy (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in adult patients with medulloblastoma is tolerable.
Detailed description
As medulloblastoma in adult patients are very rare (1.1% of all brain tumors), adults are often treated in the scope of expanded access treatments or within pediatric studies; although, it is not known whether medulloblastomas act in the same way in adulthood and in childhood. This is the first study to investigate the significance of a combination of a radiochemotherapy (vincristin) and a following maintenance chemotherapy (vincristin, cisplatin and CCNU) in adult patients with medulloblastoma with the purpose to have a starting point for the development of chemotherapeutical protocols in adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vincristin, CCNU, cis-platin | Experimental | Drug: maintenance chemotherapy (vincristin, cisplatin and CCNU), Radiation: Radiotherapyradiotherapy and concomitant chemotherapy (7 cycles of 7 days): * 2 mg/m2 vincristin i.v. * 55,0 Gy Posterior cranial fossa (M0) * 55,0 Gy Posterior cranial fossa / cerebral metastases + 49,6 Gy spinal metastases (M1-M3) maintenance chemotherapy (8 cycles of 42 days): * once at day 1 at each cycle: 70 mg/m2 cis-platin i.v. 75 mg/m2 CCNU oral 2 mg/m2 vincristin i.v. * once at day 8 and 15 at each cycle: 2 mg/m2 vincristin i.v. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- age > 18 years
- medulloblastoma (+/- postoperative residual tumor, M0) or medulloblastoma (+/- postoperative residual tumor, M1-M3) respectively
- primary diagnosis of the tumor
- no previous chemo- or radiation therapy
- Karnofsky-Index ≥ 70%
Key exclusion criteria (8 listed)
- age < 18 years
- histologically not confirmed Medulloblastoma
- by chemo- or radiotherapy treated recidive tumor
- other cancer (with exception of surgically cured carcinoma in situ of the cervix and non-melanocytic skin tumors)
- hypersensitivity or contraindication against one of the used drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| maintenance chemotherapy (vincristin, cisplatin and CCNU)Also: Vincristin: L01CA02, CCNU: Lomustin L01AD02, cis-platin: L01XA01maintenance chemotherapy of maximum of 8 cycles á 42 days | Drug | Vincristin, CCNU, cis-platin |
| RadiotherapyRadiotherapy of the partial brain | Radiation | Vincristin, CCNU, cis-platin |
Primary outcome
feasibility of the adjuvant chemotherapy
Time frame: participants will be followed for the duration of chemo therapy, an expected average of 1 year
The main objective is the feasibility of the adjuvant chemotherapy which has gained the best results when combined with radiotherapy so far. The present protocol is primarily to determine the number of interruptions of the maintenance chemotherapy due to toxicity and the kind of toxicity .
5 secondary outcomes
Number of performable cycles in chemo therapy
Time frame: participants will be followed for the duration of chemo therapy, an expected average of 6 months
3 and 5 years progression-free survival
Time frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
event-free survival
Time frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
overall survival
Time frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
course of cognitive performance/QoL
Time frame: participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Hau, MD principal investigator
Department of Neurology, University of Regensburg
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing maintenance chemotherapy (vincristin, cisplatin and CCNU) and Radiotherapy in people with Medulloblastoma, run by University of Regensburg at 15 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 12 inclusion and 8 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 31 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
feasibility of the adjuvant chemotherapy (time frame: participants will be followed for the duration of chemo therapy, an expected average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2020.