a study of medi-575 in subjects with recurrent glioblastoma multiforme

Conditions: Glioblastoma Multiforme

Summary: the primary objective of this phase ii study is to evaluate the progression-free survival at 6 months in adult subjects with a first recurrence of glioblastoma multiforme who are treated with medi-575.

this is a phase 2, multicenter, open-label, single-arm study to evaluate the antitumor activity, safety, and pharmacology of medi-575 in adult subjects with first recurrence of gbm. approximately 55 subjects will be enrolled to determine the preliminary efficacy profile of medi-575 in the treatment of subjects with first recurrence of gbm. subjects will receive medi-575 as a 60-minute iv infusion on day 1 every 21 days until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for subject withdrawal. the primary assessment of antitumor activity is pfs-6; tumor response and progression will be determined using updated response assessment criteria of high grade gliomas- neuro-oncology working group v.1. approximately 15 investigational sites in the united states will participate in this study. all subjects will be followed every 3 months for the duration of the trial (defined as 9 months from the date the last subject is entered into the trial or when the sponsor stops the study.

Eligibility criteria:
inclusion criteria: * written informed consent and hipaa authorization (applies to covered entities in the usa only) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations * age ≥18 years old at the time of screening * histologically confirmed diagnosis of world health organization grade iv malignant glioma (glioblastoma or gliosarcoma) * previous first line treatment with radiotherapy and temozolomide (treatment prior to radiation and temozolomide permitted, \[ie, gliadel\]) * documented first recurrence of gbm by diagnostic biopsy or by contrast-enhanced magnetic resonance imaging (mri) as per updated response assessment criteria of high grade gliomas- neuro-oncology working group (wen et al, 2010) * life expectancy ≥ 12 weeks * adequate hematologic and organ function * negative serum pregnancy test (women only) * two methods of birth control for female participants of child-bearing potential or male participants with their female partners of child-bearing potential exclusion criteria: * treatment with any chemotherapy, radiotherapy, immunotherapy, biologic, hormonal therapy or investigational agent 30 days prior to study entry * concurrent enrollment in another clinical study involving an investigational agent * employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals * previous mab treatment specifically directed against pdgf or pdgf receptors * previous bevacizumab or other vegf and anti-angiogenic treatment * more than 1 recurrence of gbm * any surgery (not including minor diagnostic procedures) within 2 weeks prior to baseline disease assessments; or not fully recovered from any side effects of previous procedures * history of serious allergy or reaction to any component of the medi-575 formulation * new york heart association ≥ grade 2 congestive heart failure within 6 months prior to study entry * uncontrolled or significant cardiovascular disease * history of other invasive malignancy within 5 years prior to study entry except for cervical carcinoma in situ (cis), non-melanomatous carcinoma of the skin or ductal carcinoma in situ (dcis) of the breast that have been surgically cured * history of active human immunodeficiency virus or active hepatitis b or c viral infection will be excluded to eliminate the risk of increased aes due to immune compromise. * systemic immunosuppressive therapy. * subjects taking corticosteroids must be on a stable dose for 7 days prior to initiation of treatment with medi-575 16) presence of extracranial metastatic or leptomeningeal disease

Keywords: glioblastoma