Cilengitide in Treating Younger Patients With Recurrent or Progressive High-Grade Glioma That Has Not Responded to Standard Therapy

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase II trial studies how well cilengitide works in treating younger patients with recurrent or progressive high-grade glioma that has not responded to standard therapy. Cilengitide may stop the growth of tumor cells by blocking blood flow to the tumor.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Histologically confirmed primary central nervous system (CNS) high-grade glioma, including any of the following:

• Glioblastoma multiforme

• Anaplastic astrocytoma

• Anaplastic oligodendroglioma

• High-grade astrocytoma not otherwise specified (i.e., anaplastic ganglioglioma, anaplastic mixed glioma, or anaplastic mixed glioneuronal tumors)

• No diffuse pontine gliomas, gliomatosis cerebri, and primary spinal cord high-grade astrocytoma

• Gliosarcoma

• Recurrent or progressive disease that is refractory to standard therapy

• Radiographically documented measurable disease

• Lesion must be at least twice the thickness of the image from which it is derived (e.g., 10 mm for a 5 mm slice thickness)

• No diffuse pontine gliomas

• No evidence of prior CNS bleeding

• Karnofsky performance status (PS) 50-100% (patients > 16 years of age)

• Lansky PS 50-100% (patients =< 16 years of age)

• Life expectancy >= 8 weeks

• Absolute neutrophil count (ANC) >= 1,000/μL

• Platelet count >= 100,000/μL (transfusion independent)

• Hemoglobin >= 8.0 g/dL (red blood cell [RBC] transfusions allowed)

• Creatinine clearance or radioisotope glomerular filtration rate >= 70mL/min OR serum creatinine based on age/gender as follows:

• 0.4 mg/dL (1 month to < 6 months of age)

• 0.5 mg/dL (6 months to < 1 year of age)

• 0.6 mg/dL (1 to < 2 years of age)

• 0.8 mg/dL (2 to < 6 years of age)

• 1.0 mg/dL (6 to < 10 years of age)

• 1.2 mg/dL (10 to < 13 years of age)

• 1.5 mg/dL (male) or 1.4mg/dL (female) (13 to < 16 years of age)

• 1.7 mg/dL (male) or 1.4mg/dL (female) (>= 16 years of age)

• Total bilirubin =< 1.5 times upper limit of normal (ULN) for age

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 2.5 times ULN for age

• No evidence of dyspnea at rest

• No exercise intolerance

• Pulse oximetry > 94%, if determination is clinically indicated

• Seizure disorder is allowed provided it is well-controlled with anticonvulsants

• No uncontrolled infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Recovered from all prior therapy

• No more than two prior treatments for high-grade glioma (i.e., one initial treatment and one treatment for relapse)

• More than 2 weeks since prior myelosuppressive chemotherapy (>= 6 weeks for nitrosoureas)

• At least 1 week since prior non-myelosuppressive chemotherapy, immunotherapy, or biologic therapy

• At least 2 weeks since prior local palliative radiotherapy (i.e., small port) to a symptomatic non-target lesion only

• At least 3 months since prior craniospinal radiotherapy

• At least 6 weeks since prior substantial bone marrow radiotherapy

• At least 6 months since prior allogeneic stem cell transplant (SCT) or rescue

• Patients who have undergone prior allogeneic SCT and who have graft-versus-host disease (GVHD) must have controlled GVHD that is =< grade 2

• At least 1 month since prior autologous SCT

• More than 1 week since prior growth factors (> 3 weeks for pegfilgrastim [Neulasta®])

• No other concurrent anticancer therapy, including chemotherapy or immunomodulating agents

• No other concurrent experimental agents or therapies

• No concurrent alternative or complimentary therapies

• No concurrent homeopathic medicines

• No concurrent nonsteroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid (aspirin)

• No concurrent steroids as anti-emetics

• Concurrent steroids for treatment of increased intracranial pressure allowed if on a stable or decreasing dose for >= 1 week before study entry

• Concurrent radiotherapy to localized painful lesions allowed provided >= 1 measurable lesion is not irradiated