Clinical Trial Details
Braintumor Website

[Information provided by:, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01635283 : Vaccine for Patients With Newly Diagnosed or Recurrent Low-Grade Glioma
PhasePhase 2
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

- Patients with newly diagnosed or recurrent glioma of World Health Organization (WHO)
grade II (astrocytoma, oligodendroglioma, and/or oligoastrocytoma) will be eligible
for this protocol

- Patients must have had surgical resection at University of California, Los Angeles
(UCLA), for which a separate informed consent was signed for the collection of their
tumor prior to surgery

- After surgery, a pathological diagnosis of low-grade glioma (WHO grade II) will need
to be established

- Patients must be able to read and understand the informed consent document; patients
must sign the informed consent indicating that they are aware of the investigational
nature of this study.

- Patients must have a Karnofsky performance status (KPS) rating of >= 60 prior to
initiating treatment; patients may be enrolled at a KPS of < 60 if it is felt that
the patient will have adequate opportunity to recover to a KPS of >= 60 by the
initiation of treatment

- Hemoglobin >= 9 gm%

- Absolute granulocyte count >= 1,500

- Platelet count >= 100K

- Serum glutamic pyruvate transaminase (SGPT), serum glutamic oxaloacetic transaminase
(SGOT) =< 2.5 times institutional normals

- Bilirubin =< 1.5mg%

- Blood urea nitrogen (BUN) or creatinine =< 1.5 times institutional normals

Exclusion Criteria:

- Subjects with an active infection

- Inability to obtain informed consent because of psychiatric or complicating medical

- Unstable or severe intercurrent medical or psychiatric conditions as determined by
the Investigator

- Females of child-bearing potential who are pregnant or lactating or who are not using
approved contraception

- History of immunodeficiency (e.g., human immunodeficiency virus [HIV]) or autoimmune
disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, vasculitis,
polymyositis-dermatomyositis, scleroderma, multiple sclerosis, or juvenile-onset
insulin-dependent diabetes) that may be exacerbated by immunotherapy

- Subjects with organ allografts

- Inability or unwillingness to return for required visits and follow-up exams

- Subjects who have an uncontrolled systemic malignancy that is not in remission
LinksPermanent Link to THIS page:      |      Link to official listing

Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2020 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557