Status:
COMPLETED
Ph. I Temozolomide + O6-BG + Irinotecan in Treatment of Pts w Recurrent / Progressive Cerebral Anaplastic Gliomas
Lead Sponsor:
Duke University
Collaborating Sponsors:
Keryx / AOI Pharmaceuticals, Inc.
Pharmacia
Conditions:
Glioblastoma
Gliosarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Objectives: To determine maximum tolerated dose of CPT-11 when administered following Temodar plus O6-benzylguanine To characterize any toxicity associated w combo of CPT-11 + Temodar plus O6-BG To o...
Detailed Description
Objectives of study: to determine maximum tolerated dose of CPT-11 when administered following Temodar + O6-benzylguanine (O6-BG); to characterize any toxicity associated w combo of CPT-11 + Temodar +...
Eligibility Criteria
Inclusion
- Pts have histologically confirmed diagnosis of recurrent primary malignant glioma
- Age \>18yrs
- Evidence of measurable recurrent/residual primary CNS neoplasm on contrast-enhanced MRI, unless medically contraindicated
- An interval of \>2 wks between prior surgical resection/6 wks between prior XRT/chemo, \& enrollment on protocol, unless there is unequivocal evidence of tumor progression after surgery, XRT/chemo
- KPS\>60 percent
- Adequate hematologic, renal \& liver function as demonstrated by lab values performed within 14 days, inclusive, prior to administration of chemo:
- ANC \>1500/mm3
- Platelet count \> 00,000/mm3
- Hemoglobin \> 10gm/dL
- BUN \& serum creatinine \<1.5 x ULN
- Total serum bilirubin \<1.5 x ULN
- SGOT \& SGPT \< 2.5 x ULN
- Alkaline phosphatase of\< 2 x ULN
- Pts must have recovered from any effects of major surgery.=
- Pts must have life expectancy of \>12wks
- Pts/legal guardian must give written, informed consent
Exclusion
- Pts requiring immediate XRT
- Pts have not recovered from surgery
- Pts are not neurologically stable for 2wks prior to study entry
- Pts are poor medical risks because of non-malignant systemic disease as well as those w acute infection treated w intravenous antibiotics
- Frequent vomiting/medical condition that could interfere w oral medication intake
- Previous active malignancy treated in past year except for localized in-situ carcinomas \& basal/squamous cell carcinoma of skin
- Known HIV positivity/AIDS-related illness
- Pregnant/nursing women
- Women of childbearing potential who are not using effective method of contraception. Women of childbearing potential must have negative serum pregnancy test 24 hrs prior to administration of study drug \& be practicing medically approved contraceptive precautions
- Men who are not advised to use effective method of contraception
- Prior failure of CPT-11
- Pts taking immuno-suppressive agents other than prescribed corticosteroids
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2008
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00612638
Start Date
January 1 2005
End Date
July 1 2008
Last Update
June 19 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke University Health System
Durham, North Carolina, United States, 27710