Phase II Trial of Temozolomide and Caelyx in the Treatment of Patients with Glioblastoma Multiforme following concurrent radiotherapy and chemotherapy

Phase II Trial of Temozolomide and Caelyx in the Treatment of Patients with Glioblastoma Multiforme following concurrent radiotherapy and chemotherapy to improve six month progression free survival

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000090415

Enrollment

Registered

2007-01-29

Start date

2007-02-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Standard of care post surgery for GBM is concurrent radiotherapy/chemotherapy followed by 6 months of chemotherapy (temozolomide). We have previously shown that the combination of Temozolomide with liposomal doxorubicin (caelyx) has activity in recrurrent GBM and is well tolerated. This study aims to assess whether the addition of liposomal doxorubicin to six months of post RT temozolomide is efficacious and well tolerated

Interventions

Phase II Trial of six months of oral Temozolomide (200mg/m2 days 1-5, q4 weekly) and intravenous liposomal doxorubicin (40mg/m2 q 4 weekly) (Caelyx) in standard doses in the Treatment of Patients with Glioblastoma Multiforme following concurrent radiotherapy and chemotherapy to improve six month progression free survival.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Inclusion: Newly diagnosed glioblastoma, performance status 0-2, completed post-operative concurrent radiotherapy/chemotherapy.

Exclusion criteria

Exclusion: significant co-morbidities

Outcome results