Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

This phase II trial is studying how well positron emission tomography (PET) scan using 18F-fluoromisonidazole works when given together with magnetic resonance imaging (MRI) ) in assessing tumor hypoxia in patients with newly diagnosed glioblastoma multiforme (GBM). Diagnostic procedures, such as MRI and PET scan using 18F-fluoromisonidazole (FMISO), may help predict the response of the tumor to the treatment and allow doctors to plan better treatment

Further Study Information

PRIMARY OBJECTIVES:

I. To determine the association of baseline FMISO PET uptake (hypoxic volume [HV]), highest tumor:blood ratio [T/Bmax]) and MRI parameters (Ktrans, CBV) with overall survival (OS) in participants with newly diagnosed GBM.

SECONDARY OBJECTIVES:

I. To determine the association of baseline FMISO PET uptake (HV, T/Bmax) and MRI parameters (Ktrans, CBV) with time to progression (TTP) and 6-month progression free survival (PFS-6) in participants with newly diagnosed GBM.

II. To assess the reproducibility of the baseline FMISO PET uptake parameters by implementing baseline "test" and "retest" PET scans (performed within 1 to 7 days of each other).

III. To assess the correlation between highest tissue:cerebellum ratio [T/Cmax] and T/Bmax at baseline.

IV. To assess the correlation between other MRI parameters (T1Gd, VCI, CBV-S, ADC, NAA-Cho, BOLD, T2) and OS, TTP, and PFS-6.

OUTLINE: This is a multicenter study.

Two weeks before initiation of chemoradiotherapy with temozolomide, patients undergo MRI and PET scan using FMISO. A subset of 15 patients undergo FMISO PET scans approximately 1 week before chemoradiotherapy. Blood samples are collected at baseline and periodically during study to compare image measures of tissue uptake of FMISO to blood concentrations. Tumor samples are collected from diagnostic biopsy or surgery for analysis of tumor hypoxic markers and methylguanine methyl transferase by immunohistochemical and PCR assays.

After completion of study therapy, patients are followed up every 3 months for up to 5 years.

Eligibility Criteria

Inclusion Criteria:

• Pathologically confirmed glioblastoma multiforme

• Newly diagnosed disease

• Grade IV according to WHO criteria

• Residual tumor required after surgery, including T2/FLAIR hyperintensity

• Amount of residual tumor will not impact patient eligibility

• Scheduled to receive standard fractionated radiation therapy and temozolomide

• May also receive an anti-VEGF or PARP-inhibiting therapy

• Karnofsky performance status 60-100%

• Not pregnant or nursing

• Negative pregnancy test

• Able to undergo MRI and use gadolinium-contrast agent, meeting the following criteria:

• No claustrophobia

• No metallic objects or implanted medical devices in the body (i.e., cardiac pacemaker, aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants)

• No sickle cell disease

• No renal failure

• No reduced renal function, as determined by glomerular filtration rate < 30 mL/min based on a serum creatinine level obtained within 28 days prior to study entry

• No other concurrent condition that, in the judgment of the investigator, might increase patient's risk

• No concurrent serious systemic illness, including any of the following:

• Uncontrolled intercurrent infection

• Uncontrolled malignancy

• Significant renal disease

• Psychiatric or social situations that might impact the survival endpoint of the study or limit compliance with study requirements

• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to FMISO

• Able to undergo PET or MRI (i.e., weight ≤ 350 lbs)

• Able to tolerate 100% oxygen < 10 minutes (e.g., no history of chronic obstructive pulmonary disease)

• No prior implanted radiotherapy or chemotherapy sources (i.e., wafers of polifeprosan 20 with carmustine)

• Not scheduled to receive chemotherapy, immunotherapy, or biologic agent other than temozolomide, including any anti-tumor investigational agent

• Concurrent anti-VEGF agent allowed

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

Elizabeth Gerstner

Principal Investigator

U.S.A.
Maryland
	Baltimore
	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
		Richard L Wahl	Ph: 410-955-8804
			Email: jhcccro@jhmi.edu
Massachusetts
	Boston
	Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
		Elizabeth R Gerstner	Ph: 877-726-5130
			Email: egerstner@partners.org
Ohio
	Cleveland
	Cleveland Clinic Taussig Cancer Center
		Manmeet S Ahluwalia	Ph: 216-636-0007
Pennsylvania
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Andrew Newberg	Ph: 215-662-6573
	American College of Radiology Imaging Network
		Elizabeth R Gerstner	Ph: 617-724-2887
			Email: egerstner@partners.org

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00902577
Information obtained from ClinicalTrials.gov on January 14, 2013