ATN-161 and Carboplatin in Treating Patients With Recurrent Malignant Glioma
Brain and Central Nervous System Tumors
About this trial
This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring adult anaplastic oligodendroglioma, adult gliosarcoma, adult mixed glioma, adult anaplastic astrocytoma, recurrent adult brain tumor, adult glioblastoma, adult giant cell glioblastoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed intracranial malignant glioma Original low-grade glioma histology allowed provided there is subsequent histologic confirmation of malignant glioma Any of the following diagnoses: Glioblastoma multiforme Gliosarcoma Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma not otherwise specified Recurrent disease Must have failed prior radiotherapy Must have confirmation of true progressive disease (rather than radiation necrosis) based upon either positron emission tomography or thallium scanning, MR spectroscopy, or surgical documentation of disease if radiographic recurrence is within the high-dose radiation field (for patients who underwent prior interstitial brachytherapy or stereotactic radiosurgery) Prior recent resection of recurrent or progressive tumors allowed if all of the following criteria are met: Recovered from prior surgery Evaluable disease after resection Unequivocal evidence of tumor progression by MRI Steroid dose must be stable for ≥ 5 days prior to MRI PATIENT CHARACTERISTICS: Karnofsky performance status 60-100% Life expectancy > 8 weeks WBC ≥ 3,000/mm³ Absolute neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Hemoglobin ≥ 10 g/dL (transfusion allowed) AST < 2.5 times upper limit of normal (ULN) Bilirubin < 2.5 times ULN Creatinine < 1.5 mg/dL OR creatinine clearance ≥ 60 mL/min Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 month after completion of study treatment No significant medical illness that would preclude study treatment No history of other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless disease is in complete remission and off all therapy for ≥ 1 year No active infection or serious intercurrent medical illness No disease that will obscure toxicity or dangerously alter drug metabolism Able to undergo MRI scan and receive contrast agents for perfusion scanning PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from prior therapy At least 28 days since prior cytotoxic therapy At least 14 days since prior vincristine At least 42 days since prior nitrosoureas At least 21 days since prior procarbazine At least 7 days since prior interferon, tamoxifen, thalidomide, isotretinoin, or other noncytotoxic agents (radiosensitizer does not count) At least 14 days since prior noncytotoxic investigational agents At least 42 days since prior radiotherapy No prior cisplatin, carboplatin, oxaliplatin, or platinum-containing analogue No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF) No other concurrent anticancer therapy (including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy) No other concurrent investigational drugs
Sites / Locations
- Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Phase I
Phase II
Patients receive ATN-161 IV over 10 minutes 3 times weekly in weeks 1-6 and carboplatin IV over 20 minutes in week 3 during course 1. Beginning in course 2, patients receive carboplatin IV over 20 minutes in week 1 and ATN-161 IV over 10 minutes 3 times weekly in weeks 1-4. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients receive carboplatin IV in week 1 and ATN-161 IV, at the MTD determined in phase I, 3 times weekly in weeks 1-4. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.