Lawrence Recht
BIBW 2992 With or Without Daily Temozolomide For Recurrent Malignant Glioma
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
This study is designed to assess the efficacy and safety of BIBW 2992 alone and BIBW 2992 in combination with temozolomide in patients with recurrent malignant glioma. Patients who fulfill the entrance criteria will be randomized to receive either temozolomide, BIBW 2992 or BIBW 2992 in combination with temozolomide. Stanford will be participating in Phase II only.
Recruiting Status:
RecruitingStanford Recruiting Status:
TerminatedCondition(s):
Intervention(s):
- Drug: BIBW 2992
- Drug: temozolomide
Phase:
Phase 1/Phase 2Eligibility
Ages Eligible for Study:
18 years to Any AgeGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key Inclusion Criteria:
1. Histologically-confirmed WHO Grade IV malignant glioma at first episode of recurrence after prior combined chemoradiotherapy. Patients with prior low-grade glioma are eligible if histologic assessment demonstrates transformation to WHO Grade IV malignant glioma.
2. Bi-dimensionally measurable disease with a minimum measurement of 1 cm (10 mm) in one diameter on Gd MRI performed within 14 days prior to first treatment (Day 1).
3. Age>=18 years at entry
4. KPS>=70%
5. Patients must have recovered from previous surgery and chemotherapy.
6. Written informed consent that is consistent with local law and ICH-GCP guidelines
Key Exclusion Criteria:
1. Less than 12 weeks between radiotherapy and start of study treatment, unless new enhancing lesion outside of radiation field or radiologically progressive on two consecutive MRI scans at least four weeks apart or biopsy-proven recurrence.
2. Less than two weeks from surgical resection (one week from prior stereotactic biopsy) or major surgical procedure.
3. Less than two weeks after previous chemotherapy (6 weeks from nitrosureas).
4. Less than four weeks from prior treatment with bevacizumab.
5. Treatment with other investigational drugs; participation in another clinical study within the past 2 weeks before start of therapy or concomitantly with this study.
6. Progressive disease or toxicity >=CTCAEv3 Grade 3 to protracted temozolomide dosing (defined as temozolomide administered more than 5 days/28 day cycle).
7. Active infectious disease requiring intravenous therapy.
8. Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
9. Gastrointestinal disorders that may interfere with the absorption of the study drug or chronic diarrhea.
10. Serious illness or concomitant non-oncological disease considered by the investigator to be incompatible with the protocol.
11. Patient is <3 years free of another primary malignancy except: if the other primary malignancy is either not currently clinically significant or does not require active intervention (such as a basal cell skin cancer or a cervical carcinoma in situ). Existence of any other malignant disease is not allowed.
12. Cardiac left ventricular function with resting ejection fraction <50%.
13. Absolute neutrophil count (ANC) less than 1500/mm^3.
14. Platelet count less than 100,000/mm^3.
15. Bilirubin greater than 1.5 x upper limit of institutional norm.
16. Aspartate amino transferase (AST) greater than 3 x upper limit of institutional norm.
17. Serum creatinine greater than 1.5 x upper limit of institutional norm.
18. Patients who are sexually active and unwilling to use a medically acceptable method of contraception.
19. Pregnancy or breast-feeding.
20. Patients unable to comply with the protocol.
21. Prior EGFR-directed therapy.
22. Patients presenting with second or higher number of episodes of recurrence.
Additional Study Details
Official Title:
BIBW 2992 With or Without Daily Temozolomide in the Treatment of Patients with Recurrent Malignant GliomaAnticipated start date:
7/1/2008Lead Sponsor:
Boehringer IngelheimInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
OpenControl:
noneAssignment:
ParallelEndpoints:
Safety/EfficacyPrimary Outcomes:
- 6-month progression-free survival rate
Secondary Outcomes:
- Objective tumor response according to the Macdonald criteria (R08-1053)
- Progression-free survival (PFS)
- Safety of BIBW 2992 when administered as monotherapy or in combination with daily TMZ
- Pharmacokinetic parameters of BIBW 2992 monotherapy and BIBW 2992 / TMZ combination therapy
- Evaluation of molecular determinants of response to BIBW 2992
Total Number to be Enrolled:
120Total Number to be Enrolled at Stanford:
6More Information
Secondary ID(s):
- BRNCNS0004
- U08-3179-01
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
This study is being conducted at multiple locations, including non-Stanford locations.
This listing was last updated:
6/9/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
Help
Trial Administration