Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults (NOA-07)

University of Regensburg (UR)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Medulloblastoma

Treatments: Drug: maintenance chemotherapy (vincristin, cisplatin and CCNU); Radiation: Radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01614132

NOA-07

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Vincristin, CCNU, cis-platin

Experimental group

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.

Treatment:

Drug: maintenance chemotherapy (vincristin, cisplatin and CCNU)

Radiation: Radiotherapy