Clinical trial · Interventional
Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults
Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults (NOA-07)
NCT01614132CI-TRIAL-00044368NOA-07completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Medulloblastoma | Medulloblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| maintenance chemotherapy (vincristin, cisplatin and CCNU) | Drug | — | UNRESOLVED |
| Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vincristin, CCNU, cis-platin
- description
- 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.
- interventionNames
- Drug: maintenance chemotherapy (vincristin, cisplatin and CCNU)
- Radiation: Radiotherapy
Primary outcomes (1)
- measure
- feasibility of the adjuvant chemotherapy
- timeFrame
- participants will be followed for the duration of chemo therapy, an expected average of 1 year
- description
- 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 .
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.