Glioblastoma Multiforme
Conditions
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.
Interventions
PROCEDURECyberKnife
Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.
Sponsors
Beth Israel Deaconess Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
66 Years to No maximum
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Percent Progression -Free Survival at 6 Months Will be Tabulated | 6 months |
| Progression Free Survival | consent to prgression or death |
Secondary
| Measure | Time frame |
|---|---|
| Response, Median Time to Tumor Progression,Overall Survival, Percent Overall Survival at 1 Year Will be Tabulated. | 1year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Single arm Phase II Study | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Region of Enrollment United States | 4 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
Primary
Progression Free Survival
Time frame: consent to prgression or death
Primary
The Percent Progression -Free Survival at 6 Months Will be Tabulated
Time frame: 6 months
Secondary
Response, Median Time to Tumor Progression,Overall Survival, Percent Overall Survival at 1 Year Will be Tabulated.
Time frame: 1year