Cilengitide in Treating Patients Who Are Undergoing Surgery for Recurrent or Progressive Glioblastoma Multiforme
Condition: Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor
MeSH terms: Glioblastoma; Gliosarcoma; Recurrence
Intervention: cilengitide; therapeutic conventional surgery; pharmacological study; laboratory biomarker analysis
Intervention description: Given IV; Undergo tumor resection; Correlative studies; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Cilengitide may stop the growth of glioblastoma multiforme by blocking blood flow to the
      tumor. Giving cilengitide before and after surgery may be an effective treatment for
      glioblastoma multiforme. This phase II trial is studying how well cilengitide works in
      treating patients who are undergoing surgery for recurrent or progressive glioblastoma
      multiforme.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed intracranial glioblastoma multiforme (GBM)

               -  Original diagnosis of low-grade glioma with subsequent histological confirmation
                  of GBM allowed

               -  Recurrent disease

                    -  Failed prior radiotherapy

          -  Must require a surgical procedure (gross total or near gross total resection) for
             tumor removal

          -  Performance status - Karnofsky 60-100%

          -  White Blood Count (WBC) ≥ 3,000/mm^3

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin ≥ 10 g/dL (transfusion allowed)

          -  Serum glutamic oxaloacetic transaminase (SGOT) < 2 times upper limit of normal (ULN)

          -  Bilirubin < 2 times ULN

          -  Creatinine < 1.5 mg/dL

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective barrier contraception during and for ≥ 2 weeks
             after study participation (for female patients) or for 3 months after study
             participation (for male patients)

          -  No other malignancy within the past 3 years except nonmelanoma skin cancer or
             carcinoma in situ of the cervix

          -  No active infection

          -  No other significant uncontrolled medical illness that would preclude study
             participation

          -  At least 3 weeks since prior interferon

          -  No prior cilengitide

          -  No other prior targeted antiangiogenic treatment (e.g., vatalanib, SU5416, or
             thalidomide)

          -  No concurrent anticancer immunotherapy

          -  No concurrent routine prophylactic filgrastim (G-CSF)

          -  At least 2 weeks since prior vincristine

          -  At least 3 weeks since prior procarbazine

          -  At least 6 weeks since prior nitrosoureas

          -  No concurrent anticancer chemotherapy

          -  At least 3 weeks since prior tamoxifen

          -  No concurrent anticancer hormonal therapy

          -  See Disease Characteristics

          -  At least 4 weeks since prior radiotherapy

          -  No concurrent anticancer radiotherapy

          -  Recovered from all prior therapies

          -  No more than 3 prior treatments for GBM (1 initial treatment; and treatment for 2
             relapses)

               -  For patients who received prior therapy for low-grade glioma, a subsequent
                  surgical diagnosis of high-grade glioma is considered the first relapse

          -  At least 4 weeks since prior investigational agents

          -  At least 4 weeks since prior cytotoxic therapy

          -  At least 3 weeks since other prior non-cytotoxic therapy (e.g., isotretinoin), except
             radiosensitizers

          -  No other concurrent anticancer therapy

          -  No other concurrent investigational agents