Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Cilengitide in Treating Patients Who Are Undergoing Surgery for Recurrent or Progressive Glioblastoma Multiforme

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI NABTC-0302 NABTC-03-02, NCT00112866

Objectives

Primary

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

Secondary

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

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy

• 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)

Chemotherapy

• 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

Endocrine therapy

• At least 3 weeks since prior tamoxifen
• No concurrent anticancer hormonal therapy

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy
• No concurrent anticancer radiotherapy

Surgery

• Not specified

Other

• 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

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• WBC ≥ 3,000/mm³
• Absolute neutrophil count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 g/dL (transfusion allowed)

Hepatic

• SGOT < 2 times upper limit of normal (ULN)
• Bilirubin < 2 times ULN

Renal

• Creatinine < 1.5 mg/dL

Other

• 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

Expected Enrollment

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

Outcomes

Progression-free survival at 6 months

Safety
Toxicity
Laboratory correlates

Outline

This is a multicenter study. Patients are assigned 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.



• 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.

Trial Contact Information

Trial Lead Organizations

North American Brain Tumor Consortium

Mark Gilbert, MD, Protocol chair		Ph: 713-792-8288; 800-392-1611 Email: mrgilbert@mdanderson.org

Registry Information
Official Title		Phase II Trial of EMD 121974 for Recurrent Glioblastoma : A Clinical Trial with Tissue Correlates of Response
Trial Start Date		2005-04-05
Registered in ClinicalTrials.gov		NCT00112866
Date Submitted to PDQ		2005-04-05
Information Last Verified		2007-10-15
NCI Grant/Contract Number		CA62399