Multicenter Pilot-study for the Therapy of Medulloblastoma of Adults

NCT01614132 | Completed Phase 1

• 1 other identifier: NOA-07
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Medulloblastoma

Keywords

medulloblastoma; CNS; malignant neoplasm; NOA; neuroectodermal tumor; Vincristin; CCNU; Cisplatin

Outcome Measures

Primary Outcomes (1)

• 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 .

  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

  participants will be followed for the duration of chemo therapy, an expected average of 6 months

• 3 and 5 years progression-free survival

  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

  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

  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

  participants will be followed for the duration of chemo therapy and in the follow-up periode, an expected average of 3 to 5 years

Study Arms (1)

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.

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

Interventions

maintenance chemotherapy (vincristin, cisplatin and CCNU) DRUG

maintenance chemotherapy of maximum of 8 cycles á 42 days

Also known as: Vincristin: L01CA02, CCNU: Lomustin L01AD02, cis-platin: L01XA01

Vincristin, CCNU, cis-platin

Radiotherapy RADIATION

Radiotherapy of the partial brain

Vincristin, CCNU, cis-platin

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Regensburg: lead

Study Sites (15)

Vivantes Netzwerk für Gesundheit GmbH

Berlin, 10249, Germany

Location

Neurologische Universitätsklinik

Bochum, 44892, Germany

Location

Universitätsklinikum Bonn

Bonn, 53105, Germany

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Universitätsklinikum Schleswig-Holstein

Lübeck, 23538, Germany

Location

Otto-von-Guericke Universität

Magdeburg, 39120, Germany

Location

Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Universitätsklinikum Münster

Münster, 48149, Germany

Location

Universitätsklinikum Regensburg

Regensburg, 93053, Germany

Location

Katharinenhospital

Stuttgart, 70174, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Universitätsklinikum Ulm

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Medulloblastoma; Neoplasms; Neuroectodermal Tumors

Interventions

Maintenance Chemotherapy; Vincristine; Cisplatin; Lomustine; Radiotherapy

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neuroectodermal Tumors, Primitive; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds

Study Officials

• Peter Hau, MD

  Department of Neurology, University of Regensburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Clinical Neurooncology

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: June 7, 2012
• Study Start: January 1, 2009
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2018
• Last Updated: March 31, 2020

Record last verified: 2020-03

Locations

DE (15)