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

Phase 2
18 Years
Not Enrolling
Adult Giant Cell Glioblastoma, Adult Glioblastoma, Adult Gliosarcoma, Recurrent Adult Brain Tumor

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Trial Information

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


I. Determine the 6-month progression-free survival rate in operative patients with recurrent
or progressive glioblastoma multiforme treated with cilengitide.


I. Determine the safety and toxicity of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment groups for
the preoperative treatment component.

Preoperative Treatment Group I: Patients receive high-dose cilengitide IV over 1 hour on
days -8, -4, and -1.

Preoperative Treatment Group II: Patients receive low-dose cilengitide IV over 1 hour on
days -8, -4, and -1.

Resection: All patients undergo tumor resection on day 0.

Postoperative Treatment: Beginning within 2 weeks after surgery, all patients receive
high-dose cilengitide IV over 1 hour twice weekly for 4 weeks. Treatment repeats every 4
weeks for up to 24 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 44 patients (22 per preoperative treatment group) will be
accrued for this study.

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

- At least 3 weeks since prior interferon

- No prior cilengitide

- No other prior targeted antiangiogenic treatment (e.g., vatalanib, SU5416, or

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

Mark Gilbert

Investigator Role:

Principal Investigator

Investigator Affiliation:

North American Brain Tumor Consortium


United States: Food and Drug Administration

Study ID:




Start Date:

January 2005

Completion Date:

Related Keywords:

  • Adult Giant Cell Glioblastoma
  • Adult Glioblastoma
  • Adult Gliosarcoma
  • Recurrent Adult Brain Tumor
  • Brain Neoplasms
  • Glioblastoma
  • Gliosarcoma



North American Brain Tumor Consortium Watertown, Massachusetts  02472