Ph. I Temozolomide + O6-BG + Irinotecan in Treatment of Pts w Recurrent / Progressive Cerebral Anaplastic Gliomas

Completed · Phase 1

Conditions studied: Glioblastoma, Gliosarcoma

In brief

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 observe pts for clinical antitumor response when treated w combo of CPT-11 + Temodar + O6-BG

Key facts

Study ID

NCT00612638

Run by

Duke University

People needed

96

Starts

2005-01-01

Expected to finish

2008-07-01

Last updated by the study team

2013-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Duke University Health System — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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