Clinical Trial Finder

DISEASE CHARACTERISTICS.

• - Histologically confirmed diagnosis of recurrent/progressive GBM presenting in first, second, or third relapse (progression following anti-cancer therapy other than surgery) - Bidimensionally measurable recurrent or residual primary disease on contrast-enhanced MRI.

PATIENT CHARACTERISTICS.Age: • 18 and over.Hematopoietic:

• - ANC ≥ 1,500/mL.

• - Platelets ≥ 100,000/mL.

• - Hemoglobin ≥ 9.0g/dL.

Hepatic:

• - AST and ALT ≤ 1.5 x ULN.

• - Bilirubin ≤ 1.5 x ULN.

Coagulation: • INR < 1.5 or PT within normal limits; and PTT within normal limits.Renal: Creatinine ≤ 1.5 x ULN; Urine protein/creatinine ratio ≤ 1.Cardiovascular.

• - 2-dimensional echocardiogram or cardiac multigated acquisition (MUGA) scan demonstrating left ventricular ejection fraction within the institutional normal range.

• - No coronary artery bypass graft, angioplasty, vascular stenting, myocardial infarction, unstable angina, congestive heart failure within the preceding 12 months.

• - No thrombotic or embolic cerebrovascular accident, including transient ischemic attacks within the past 12 months and no conditions that would not permit the safe discontinuation of specified anti-platelet medications.

• - No intraparenchymal CNS hemorrhage, except for Grade 1 intraparenchymal hemorrhage in the immediate post-operative period or Grade 1 intraparenchymal hemorrhage that has been stable or improved.

Immunologic: • Not known to have human immunodeficiency virus infection (HIV) or active hepatitis B or C virus infection.Other:

• - Negative pregnancy test within 72 hours prior to drug administration.

• - Not pregnant or breast feeding.

• - Fertile patients must agree to use effective methods of birth control and must agree to do so until at least 4 weeks after the last dose of drug administration.

• - No serious non-healing wound, ulcer or bone fracture or recent significant traumatic injury (within 4 weeks) - Have ability to understand and sign an informed consent document.

• - Be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

• - No other malignancy within the past 3 years, except for basal cell skin cancer, cervical carcinoma in situ, or other primary malignancy that is not currently clinically significant or does not require active intervention.

• - No prior grade 3 or greater toxicity to irinotecan.

• - No other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that could increase the risks associated with study participation or study drug administration or could interfere with the interpretation of the study results and would make the patient inappropriate for study entry.

PRIOR CONCURRENT THERAPY: Biologic therapy:

• - See Disease Characteristics.

• - At least 4 weeks between prior biological or immunotherapy and recovered.

Chemotherapy:

• - See Disease Characteristics.

• - At least 4 weeks since prior chemotherapy and recovered (6 weeks for nitrosoureas), unless there is unequivocal evidence of tumor progression.

Radiotherapy: • At least 12 weeks from completion of standard, daily radiotherapy and recovered, unless any of the following occurs:

• - New area of enhancement on MRI that is outside the radiotherapy field.

• - Biopsy-proven recurrent tumor.

• - Radiographic evidence of progressive tumor on 2 consecutive scans taken ≥ 4 weeks apart.

Surgery.

• - At least 4 weeks since major surgery, open biopsy or significant traumatic injury and recovered.

• - At least 1 week since other prior biopsy.

Other:

• - Not concurrently enrolled in another therapeutic clinical trial involving ongoing therapy.

• - No prior treatment with VEGF or VEGFR inhibitors or vascular targeting/disrupting agents.

• - No prior CT-322 therapy.

• - No prior failure of irinotecan therapy.

• - No prior treatment with stereotactic radiosurgery, brachytherapy, or a surgically created resection cavity to support other anatomically localized therapies.

- No severe or uncontrolled medical disease (uncontrolled diabetes, hypertension, serious infection > CTCAE grade 2, significant bleeding or platelet dysfunction, gastrointestinal bleed)

Arms

Experimental: 1

CT-322

Experimental: 2

CT-322 and irinotecan hydrochloride

Interventions

Drug: - CT-322

IV solution, weekly

Drug: - irinotecan hydrochloride

IV solution, biweekly