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

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborators: Keryx / AOI Pharmaceuticals, Inc.; Pharmacia
• Treatments: Anticonvulsants; Camptothecin; Carbamazepine; Convulsants; Dacarbazine; Irinotecan; O(6)-benzylguanine; Phenobarbital; Phenytoin; Temozolomide

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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