Ph I 5-Day Temo + O6-BG in Treatment of Pts w Recurrent / Progressive GBM
Information source: Duke University
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glioblastoma; Gliosarcoma
Intervention: Temodar and O6-Benzylguanine (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: Duke University Official(s) and/or principal investigator(s):
Jennifer A. Quinn, MD, Principal Investigator, Affiliation: Duke University Health System
Summary
Primary objectives To determine maxi tolerated dose of Temodar® in combo w O6-benzylguanine
administered for 5 consecutive days in pts w progressive/recurrent GBM To characterize
toxicity associated w Temodar® in combo w O6-BG administered for 5 consecutive days in pts w
progressive/recurrent GBM To determine Neulasta®-supported MTD defined as the MTD of Temodar®
in combo with O6-BG administered for 5 days while receiving Neulasta® once per treatment
cycle between days 7 & 14 in pts w progressive/recurrent GBM To obtain preliminary response
rates of Temodar® in combo w O6-BG administered for 5 consecutive days in pts w
progressive/recurrent GBM
Clinical Details
Official title: Phase I Trial of a 5-Day Regimen of Temodar Plus O6-Benzylguanine (O6-BG) in the Treatment of Patients With Recurrent / Progressive Glioblastoma Multiforme
Study design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Dose limiting toxicity
Secondary outcome: Progression-free survival
Detailed description:
1 primary objective is to determine maximum tolerated dose of Temodar in combo w
O6-benzylguanine administered for 5 consecutive days in pts w progressive/recurrent GBM.
Another primary objective is to characterize toxicity associated w Temo in combo w O6-BG
administered for 5 consecutive days in pts w progressive/recurrent GBM. 3rd primary objective
is to determine Neulasta-supported MTD defined as MTD of Temo in combo w O6-BG administered
for 5 days while receiving Neulasta once per treatment cycle between days 7 & 14 in pts w
progressive/recurrent GBM. Secondary objective is to obtain preliminary response rates of
Temodar in combo w O6-BG administered for 5 consecutive days in pts w progressive/recurrent
GBM. Population is Glioblastoma. O6-BG Administration: O6-BG 120mg/m2 administered
intravenously over 1 hr followed by continuous infusion of O6-BG at 30mg/m2/day for 5
consecutive days. Every 48hrs repeat dose of 120mg/m2 over 1hr administered for total of 3
doses.
Temodar Administration: Temodar administered orally, in fasting state within 60 mins of end
of 1st 1-hr infusion of O6-BG & then every 24 hrs during continuous infusion of O6-BG. Temo
administered on day 1 of treatment cycle and every 24 hrs thereafter for 5 days w treatment
cycles repeated every 28 days. Body surface area calculated at beginning of each cycle will
be used to calculate daily dose of Temo administered for that cycle.
Neulasta Administration. Neulasta administered by subcutaneous injection in 0. 6mL pre-filled
syringe containing 6mg of pegfilgrastim. It will be administered once per chemotherapy cycle
between days 7 & 14. Neulasta should not be administered in period between 14 days before &
24hrs after administration of cytotoxic chemo including Temo.
Data Analysis will be conducted by Biostatistics department of Duke.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Pts have histologically proven supratentorial GBM
- Pts have recurrent/progressive MG. If pt received stereotactic radiosurgery /
brachytherapy as part of their prior therapy, then histologic confirmation of
recurrence/metabolic imaging consistent w recurrent tumor is recommended but not
mandated
- There must be measurable disease on contrast-enhanced magnetic resonance imaging study
/ CT scan performed <2wks of study drug administration
- Interval of >12 wks between completion of XRT & enrollment on protocol
- Interval of >4 wks between prior chemo & enrollment on protocol unless there is
unequivocal evidence of tumor progression
- Interval of >2 wks between prior surgical resection & enrollment on protocol unless
there is unequivocal evidence of tumor progression
- Age >18 yrs
- KPS >70 percent
- Following baseline study will be required <1wk of study drug administration: serum
creatinine < 1. 5 x ULN & Hematologic Status
- Following baseline studies will be required <1wk of study drug administration:
absolute neutrophil count >2000 cells/microliter; platelet count >125,000
cells/microliter
- Following baseline studies will be required <1 wk of study drug administration: serum
SGOT & total bilirubin < 2. 5 x ULN
- Signed informed consent, approved by IRB, will be obtained prior to initiating
treatment
- Pts w Reproductive Potential: Pts must agree to practice effective birth control
measures while on study & for 2 months after completing therapy
Exclusion Criteria:
- Pregnant/breast feeding women/ women/men w reproductive potential not practicing
adequate contraception. Therapy may be associated w potential toxicity to fetus/child
that exceeds mini risks necessary to meet health needs of mother
- Prior treatment w O6-BG + Temo in combo
- Active infection requiring intravenous antibiotics
- Known diagnosis of HIV infection
- Pts w history of another primary malignancy that is currently clinically
significant/currently requires active intervention
- Pts unwilling/unable to comply w protocol due to serious medical/psychiatric
condition
- Pts who have received investigational drugs <2 wks prior to start on study drug/have
not recovered from side effects of such therapy.
Locations and Contacts
Duke University Health System, Durham, North Carolina 27710, United States
Additional Information
The Preston Robert Tisch Brain Tumor Center at DUKE
Starting date: February 2005
Ending date: August 2009
Last updated: May 4, 2008
|
