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Phase I/II Study of Fractionated CyberKnife Stereotactic Radiosurgery for High Grade Gliomas in Elderly Patients With Poor Performance Status


Phase 1/Phase 2
66 Years
N/A
Open (Enrolling)
Both
Glioblastoma Multiforme

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Trial Information

Phase I/II Study of Fractionated CyberKnife Stereotactic Radiosurgery for High Grade Gliomas in Elderly Patients With Poor Performance Status


Inclusion Criteria:



1. Histopathologically confirmed newly diagnosed glioblastoma multiforme or Anaplastic
Glioma (WHO Grade III) by surgical excision or biopsy.

2. Patient must recover from the effects of surgery, post-operative infection, or other
complications.

3. Therapy should start within 5 weeks of surgery

4. Must have an estimated survival of > 8 weeks.

5. KPS < 70.

6. Age > 65 years.

7. Must have a pre- and post operative contrast enhanced MRI scans

8. Laboratory values within the following limits: ANC (absolute neutrophil count) >/=
1500 cell/ul Platelets >/= 100x 10(3)/ul, Hemoglobin >/= 9g/dl, Serum Creatinine ≤
1.5mg/dl., Serum total Bilirubin 2.5x ULN, Albumin >/= 3g/dl.

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Exclusion Criteria:

1. Histology grade less than Anaplastic Glioma ( WHO Grade III).

2. Recurrent malignant glioma.

3. Tumor involving the Brain stem.

4. Any detected tumor foci beyond the cranial vault.

5. Major medical or psychiatric illness, which in the investigator's opinion will
prevent administration or completion of the protocol therapy.

6. Prior malignancies, except for non-melanomatous skin cancers, or carcinoma in situ of
uterus, cervix or bladder, unless disease free for > 5 years.

7. Prior chemotherapy for the current disease.

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Type of Study:

Interventional

Study Design:

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

Outcome Measure:

The percent progression -free survival at 6 months will be tabulated

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Anand Mahadevan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Institutional Review Board

Study ID:

2006P-000464

NCT ID:

NCT00456612

Start Date:

February 2007

Completion Date:

December 2009

Related Keywords:

  • Glioblastoma Multiforme
  • Glioblastoma

Name

Location

Beth Israel Deaconess Medical Center Boston, Massachusetts  02215