Clinical trial NCT00456612: 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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Glioblastoma Multiforme
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2007-04-05
Enrollment: 4
Sex: ALL
Minimum age (years): 66
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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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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Primary outcomes:
measure: The Percent Progression -Free Survival at 6 Months Will be Tabulated
timeFrame: 6 months
measure: Progression Free Survival
timeFrame: consent to prgression or death
Secondary outcomes:
measure: Response, Median Time to Tumor Progression,Overall Survival, Percent Overall Survival at 1 Year Will be Tabulated.
timeFrame: 1year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Anand Mahadevan, MD
role: PRINCIPAL_INVESTIGATOR
References: