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Radiosurgery for Glioblastoma Multiforme

Primary Purpose

Glioblastoma Multiforme

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CyberKnife
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glioblastoma Multiforme

Eligibility Criteria

66 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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 </= 1.5 x upper limit of normal (ULN), SGOT/SGPT </= 2.5x ULN, Albumin >/= 3g/dl.

    -

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.

    -

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Cyberknife

Arm Description

Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.

Outcomes

Primary Outcome Measures

The Percent Progression -Free Survival at 6 Months Will be Tabulated
Progression Free Survival

Secondary Outcome Measures

Response, Median Time to Tumor Progression,Overall Survival, Percent Overall Survival at 1 Year Will be Tabulated.

Full Information

First Posted
April 4, 2007
Last Updated
January 23, 2017
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00456612
Brief Title
Radiosurgery for Glioblastoma Multiforme
Official Title
Phase I/II Study of Fractionated CyberKnife Stereotactic Radiosurgery for High Grade Gliomas in Elderly Patients With Poor Performance Status
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Poor accrual
Study Start Date
February 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Conventional radiation for 6 weeks is not well tolerated by the elderly. Shorter courses (over 3-5 weeks) of radiation have been shown to be equivalent in outcome the elderly- particularly in patients who are generally in poor performance status (KPS<70). Fractionated Cyberknife Radiosurgery can deliver equivalent doses in 5 treatments providing the same tumor control in a much shorter and tolerable schedule improving their quality of their short life. To assess the tolerability of Cyberknife Radiosurgery for High Grade Gliomas in Elderly with poor performance status. Secondary: Assessment of local control rate, progression free survival, overall survival, quality of life and toxicity and steroid dependence in this population with this regime.
Detailed Description
Conventional radiation for 6 weeks is not well tolerated by the elderly. Shorter courses (over 3-5 weeks) of radiation have been shown to be equivalent in outcome the elderly- particularly in patients who are generally in poor performance status (KPS<70). Fractionated Cyberknife Radiosurgery can deliver equivalent doses in 5 treatments providing the same tumor control in a much shorter and tolerable schedule improving their quality of their short life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma Multiforme

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyberknife
Arm Type
Other
Arm Description
Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.
Intervention Type
Procedure
Intervention Name(s)
CyberKnife
Intervention Description
Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.
Primary Outcome Measure Information:
Title
The Percent Progression -Free Survival at 6 Months Will be Tabulated
Time Frame
6 months
Title
Progression Free Survival
Time Frame
consent to prgression or death
Secondary Outcome Measure Information:
Title
Response, Median Time to Tumor Progression,Overall Survival, Percent Overall Survival at 1 Year Will be Tabulated.
Time Frame
1year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histopathologically confirmed newly diagnosed glioblastoma multiforme or Anaplastic Glioma (WHO Grade III) by surgical excision or biopsy. Patient must recover from the effects of surgery, post-operative infection, or other complications. Therapy should start within 5 weeks of surgery Must have an estimated survival of > 8 weeks. KPS < 70. Age > 65 years. Must have a pre- and post operative contrast enhanced MRI scans 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 </= 1.5 x upper limit of normal (ULN), SGOT/SGPT </= 2.5x ULN, Albumin >/= 3g/dl. - Exclusion Criteria: Histology grade less than Anaplastic Glioma ( WHO Grade III). Recurrent malignant glioma. Tumor involving the Brain stem. Any detected tumor foci beyond the cranial vault. Major medical or psychiatric illness, which in the investigator's opinion will prevent administration or completion of the protocol therapy. Prior malignancies, except for non-melanomatous skin cancers, or carcinoma in situ of uterus, cervix or bladder, unless disease free for > 5 years. Prior chemotherapy for the current disease. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anand Mahadevan, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

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Radiosurgery for Glioblastoma Multiforme

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