Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, 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.]

NCT02709226 : Dose Escalation Trial of Re-irradiation in Good Prognosis Recurrent Glioblastoma
PhasePhase 1
AgesMin: 18 Years Max: 99 Years
Eligibility
- INCLUSION CRITERIA:

1. Histological diagnosis

Previous histologic diagnosis of glioblastoma, transformation to glioblastoma or
gliosarcoma established by biopsy or resection prior to enrollment as evident on
NIH or outside pathology.

2. Patients must be age greater than or equal to 18.

3. Patients should have a KPS greater than or equal to 70%

4. Prior standard radiation therapy to a dose ranging from 50 to 60 Gy at 1.8 to 2
Gy per fraction.

5. Patients must be more than or equal to 14 days from previous cytotoxic treatment.

6. Concurrent therapy

The concurrent use of bevacizumab is allowed if previously initiated for tumor
progression or symptomatic management. Prior temozolomide or other cytotoxic
chemotherapy is allowed.

7. Ability of subject or Legally Authorized Representative (LAR) to understand and
the willingness to sign a written informed consent document.

8. Women of child-bearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control; abstinence) prior to study entry
and for the duration of study participation. Should a woman become pregnant or
suspect she is pregnant while she or her partner is participating in this study,
she should inform her treating physician immediately.

EXCLUSION CRITERIA:

1. Prior therapy < than 2 weeks since surgical re-resection or biopsy

2. Pregnant or breast feeding females are excluded due to potential mutagenic effects on
the developing fetus or newborn

3. Preexisting grade 3 or 4 nervous system disorder as per CTCAE Version 4.03

4. Clinically significant unrelated systemic illness (including but not limited to active
life threatening infection, cardiac or neurologic events, current hospital admission
for a coexisting comorbid illness), which would make it impossible for the patient to
tolerate re-irradiation or systemic chemotherapy or likely to interfere with the
results.

5. Patients exhibiting baseline grade 3 or 4 by CTCAE criteria are excluded due to
difficulty in assigning these to the study intervention as treatment related DLT.

6. Patients with preexisting known or suspected radiation sensitivity syndromes will be
excluded due to potential confounding effect on outcome.
LinksPermanent Link to THIS page: http://virtualtrials.com/nct/display1trial.cfm?nct=NCT02709226      |      Link to official Clinicaltrials.gov listing
Locations
Bethesda, Maryland
Facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
Investigator:
Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office Phone: 888-624-1937
Email not avaialable




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