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A Phase II Trial of Low Dose Fractionated Radiation Therapy as a Chemo-Potentiator of Salvage Temozolomide for Recurrent Anaplastic Astrocytoma and Glioblastoma Multiforme


Phase 2
18 Years
N/A
Open (Enrolling)
Both
High Grade Glioma

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Trial Information

A Phase II Trial of Low Dose Fractionated Radiation Therapy as a Chemo-Potentiator of Salvage Temozolomide for Recurrent Anaplastic Astrocytoma and Glioblastoma Multiforme


In vitro and in vivo studies have suggested that low dose fractionated radiation therapy
(LDFRT) may be used to potentiate full dose chemotherapy, decreasing the development of
resistance found with standard doses of radiation and chemotherapy. This is a
nonrandomized, open label, single institution phase II trial with a safety run-in to
evaluate the safety and efficacy of LDFRT plus temozolomide in patients with High Grade
Glioma (to only include Anaplastic Astrocytoma or Glioblastoma Multiforme) previously
treated with surgical resection followed by adjuvant radiation therapy plus temozolomide.
The primary objective of the phase II study is to estimate response rate in patients treated
with twice daily fractions of low dose radiation plus temozolomide chemotherapy.


Inclusion Criteria:



- Patients must have recurrent GBM (Glioblastoma Muliforme)or Anaplastic Astrocytoma.

- The diagnosis of GBM or Anaplastic Astrocytoma.

- Patients must have been previously treated with surgical resection (any extent okay)
and adjuvant radiation therapy plus temozolomide.

- Patients must be at least 12 months from completion of radiation therapy

- At least 2 months from completion of temozolomide (to be consistent with the the
"rechallenge" group from Perry et al. JCO 2010).

- Age >18 years

- ECOG performance status <2 (Karnofsky >60%, see appendix A).

- There must be measurable disease on MRI.

- Patients must have normal organ and marrow function as defined below:

- Women must not be pregnant

- Ability to understand and the willingness to sign a written informed consent document

- Temozolomide re-treatment is planned by the treating neuro-oncologist.

- The most recent brain tumor pathology obtained for the patient must be glioblastoma.

Exclusion Criteria:

- Must be able to receive an MRI

- Patients may not be receiving any other investigational cancer treatment agents at
the time of enrollment.

- Patients may not have previously failed treatment with salvage temozolomide.

- Patients may not have previously failed treatment with a VEGF inhibitor.

- Patients may not have previously been treated with >1 course of radiotherapy.

- Patients may not have previously been treated with radiosurgery to the brain.

- Uncontrolled intercurrent illness

- Pregnant and breastfeeding women are excluded. Women of child-bearing potential who
are unwilling or unable to use and acceptable method of birth control to avoid
pregnancy for the entire study period and up to 12 weeks after the study are
excluded. Male subjects must also agree to use effective contraception for the same
period as above.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response Rate

Outcome Description:

To estimate the response rate to salvage temozolomide plus LDFRT.

Outcome Time Frame:

3, 6 and 12 month follow-up after therapy has been completed

Safety Issue:

No

Principal Investigator

Kristin Redmond, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Institutional Review Board

Study ID:

J-11120

NCT ID:

NCT01466686

Start Date:

September 2012

Completion Date:

May 2015

Related Keywords:

  • High Grade Glioma
  • Recurrent Glioblastoma Multiforme
  • Recurrent Anaplastic Astrocytoma
  • Surgery
  • Adjuvant Radiation
  • Adjuvant Temozolomide
  • Glioblastoma
  • Glioma
  • Astrocytoma

Name

Location

The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231