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

NCT00112866 | Terminated Phase 2 Results DMC

• 4 other identifiers: NCI-2012-02653CDR0000428409NABTC-03-02U01CA062399
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adult Giant Cell Glioblastoma; Adult Glioblastoma; Adult Gliosarcoma; Recurrent Adult Brain Tumor

Outcome Measures

Primary Outcomes (1)

• 6m-Progression-free Survival

  progression within 6 months (26 weeks) of treatment

  6 months

Secondary Outcomes (7)

• Changes in avb3 Integrin Expression on Tumor Cells and Endothelial Cells

  Baseline and time of surgery

• Changes in Vitronectin Expression

  Baseline and time of surgery

• Changes in Tumor Cell Apoptosis

  Baseline and time of surgery

• Changes in Tumor Cell Proliferation

  Baseline and time of surgery

• Changes in Endothelial Cell Apoptosis

  Baseline and up to 4 years

Other Outcomes (1)

• Overall Progression Free Survival

  1 year

Study Arms (2)

Group I (high-dose cilengitide) 2000mg

EXPERIMENTAL

Preoperative Treatment: Patients receive high-dose cilengitide IV over 1 hour on days -8, -4, and -1. (High dose 2000mg) 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.

Drug: cilengitide; Procedure: therapeutic conventional surgery; Other: pharmacological study; Other: laboratory biomarker analysis

Group II (low-dose cilengitide) 500mg

EXPERIMENTAL

Preoperative Treatment: Patients receive low-dose cilengitide IV over 1 hour on days -8, -4, and -1. (500mg) 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

Drug: cilengitide; Procedure: therapeutic conventional surgery; Other: pharmacological study; Other: laboratory biomarker analysis

Interventions

cilengitide DRUG

Given IV

Also known as: EMD 121974

Group I (high-dose cilengitide) 2000mg; Group II (low-dose cilengitide) 500mg

therapeutic conventional surgery PROCEDURE

Undergo tumor resection

Group I (high-dose cilengitide) 2000mg; Group II (low-dose cilengitide) 500mg

pharmacological study OTHER

Correlative studies

Also known as: pharmacological studies

Group I (high-dose cilengitide) 2000mg; Group II (low-dose cilengitide) 500mg

laboratory biomarker analysis OTHER

Correlative studies

Group I (high-dose cilengitide) 2000mg; Group II (low-dose cilengitide) 500mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

North American Brain Tumor Consortium

Watertown, Massachusetts, 02472, United States

Location

MeSH Terms

Conditions

Glioblastoma; Gliosarcoma; Brain Neoplasms

Interventions

Cilengitide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Limitations and Caveats

Study closed early due to slow accrual. Molecular analyses evaluating alterations were planned for the study, unfortunately, majority of tumor samples were too small to do analysis and also there were unforeseen freezer issues.

Results Point of Contact

• Title: Mark Gilbert, MD
• Organization: Adult Brain Tumor Consortium (ABTC)

jfisher@jhmi.edu

410-955-8837

Study Officials

• Mark Gilbert

  North American Brain Tumor Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2005
• First Posted: June 3, 2005
• Study Start: January 1, 2005
• Primary Completion: December 1, 2008
• Study Completion: March 1, 2009
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)