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A Phase II Protocol for the Use of Neuradiab® Combined With Bevacizumab (Avastin) Therapy in Patients With Recurrent Glioblastoma Multiforme

Phase 2
18 Years
Not Enrolling
Brain Tumors

Thank you

Trial Information

A Phase II Protocol for the Use of Neuradiab® Combined With Bevacizumab (Avastin) Therapy in Patients With Recurrent Glioblastoma Multiforme

At present there are no satisfactory therapies for these patients with recurrent GBM and the
practitioner is left with best effort combination therapy for this disease. At present a
number of chemotherapeutic agents, including nitrosoureas, carboplatin, bevacizumab,
etoposide, irinotecan, and imatinib, have been used as salvage therapy either alone or in
combination. Additional trials with a variety of agents are underway, but preliminary
results from single-agent studies have been disappointing. Currently, only nitrosoureas
(lomustine and carmustine), including Gliadel® Wafer (carmustine) as adjunct to surgery, are
approved for use in previously treated GBM. At present the treatment of recurrent disease
with any available agent results in median survival in the ranges of 22-44 weeks. The
historical data from previous human exposure with Neuradiab is highly suggestive of a
benefit to patient survival.

Since Neuradiab® has shown promising efficacy in patients with recurrent disease with
acceptable risk-benefit ratio, and since there is no substantial survival benefit from
currently available agents used to treat this patient population, Neuradiab® is being
proposed as an experimental alternative to recurrent GBM patients under a Single-Center
Phase II Trial. Recurrent GBM is a serious and immediately life-threatening disease, for
which there is no comparable or satisfactory alternative drug or other therapy available to
treat that stage of the disease. Overall, survival data indicate a need for more effective
treatments for recurrent GBM.

Inclusion Criteria:

- Previous histopathology confirmed diagnosis of (World Health Organization [WHO] grade
IV astrocytoma; (

- Patients with recurrent disease presenting as a supratentorial unifocal lesion seen
on magnetic resonance imaging (MRI) suspicious for glioblastoma multiforme will be
considered as long as:

1. Patient is eligible for or has undergone a gross total surgical resection of
the tumor mass with a residual ridge ≤ 1cm

2. A post-operative MRI will be obtained within 72 hours of resection and must show
an adequate resection defined by ≤ 1 cm enhancement.

- No evidence of hemorrhage on the baseline MRI or CT scan other than those that are
postoperative grade 1.

- Age ≥ 18 years of age at the time of study entry.

- Karnofsky Performance Status ≥ 70%.

- Adequate bone marrow function

- Adequate hepatic function

- Adequate renal function

- Patient must be HAMA negative prior to study entry

- Able to tolerate standard post operative management for GBM debulking including
corticosteroid therapy

- An interval of at least 30 days from prior chemotherapy (6 weeks for nitrosoureas) or
investigational agent unless the patient has recovered from all anticipated
toxicities associated with that therapy

- Women of childbearing potential must have a negative pregnancy test (serum or urine).

- The patient must agree to use an effective contraceptive method

- Patient must give written informed consent prior to any study-specific procedures
being implemented

Exclusion Criteria:

- Infratentorial tumor, tumor with subependymal spread, multifocal tumor, tumor with
ventricular communication, intraventricular tumor or tumor which is within one gyrus
(approximately 1cm) of the motor/sensory strip, either of the speech centers, or
exceeds beyond the cranial vault.

- Severe, active comorbidity, including any of the following:

1. Unstable angina and/or congestive heart failure requiring hospitalization

2. Transmural myocardial infarction within the last 6 months

3. Acute bacterial or fungal infection requiring intravenous antibiotics at the
time of study entry

4. Chronic obstructive pulmonary disease exacerbation or other respiratory illness
requiring hospitalization or precluding study therapy at the time of study entry

5. Known hepatic insufficiency resulting in clinical jaundice (excluding Gilbert's
syndrome) and/or coagulation defects

6. Known AIDS based upon current CDC definition

7. Major medical illnesses or psychiatric impairments that, in the investigator's
opinion, will prevent administration or completion of protocol therapy

8. Active connective tissue disorders, such as lupus or scleroderma that, in the
opinion of the treating physician, may put the patient at high risk for
radiation toxicity.

- History of severe allergic reaction to contrast media.

- Any serious medical condition or psychiatric illness unresponsive to medical

- Prior malignancy if active treatment was required during the previous 3 years (except
for adequately treated basal cell or squamous cell skin cancer and prior GBM)

- Known hypersensitivity to murine proteins.

- Inability to undergo an MRI.

- Patient has been treated with any anti-angiogenic therapy within 30 days prior to
study entry

- Co-medication that may interfere with study results; e.g. immuno-suppressive agents
other than corticosteroids

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The safety of Neuradiab® when followed by Avastin therapy will be assessed based on Investigator reported symptomatic toxicity findings on physical exam, and Adverse Events.

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

David A. Reardon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Preston Robert Tisch Brain Tumor Center


United States: Food and Drug Administration

Study ID:




Start Date:

May 2009

Completion Date:

December 2010

Related Keywords:

  • Brain Tumors
  • Recurrent Glioblastoma multiforme (GBM)
  • Recurrent Brain Tumor
  • Recurrent Brain Disease
  • Neuradiab
  • Avastin
  • Bevacizumab
  • Brain Neoplasms
  • Glioblastoma



The Preston Robert Tisch Brain Tumor CenterDurham, North Carolina  27710