Phase II Trial of EMD 121974 for Recurrent Glioblastoma : A Clinical Trial With Tissue Correlates of Response

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%

- WBC ≥ 3,000/mm^3

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 10 g/dL (transfusion allowed)

- 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