Use of Optune TTF With Radiation as an Alternative for Elderly Patients With Primary CNS Lymphoma
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Brain Cancer, Brain Cancer, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 70 - Any |
| Updated: | 10/5/2018 |
| Start Date: | October 2018 |
| End Date: | October 2024 |
| Contact: | Scott G Turner, MD |
| Email: | sgturner@saintlukeskc.org |
| Phone: | 816-932-2700 |
This study will compare the overall survival (OS) time of elderly patients who would not
tolerate standard chemotherapy for PCNSL treated with WBXRT together with Optune-TTF to those
treated with whole-brain radiotherapy alone.
Standard treatment of primary central nervous system lymphoma (PCNSL) for patients with good
performance status involves high-dose methotrexate-based chemotherapy regimens and
whole-brain radiation therapy (WBXRT). Although up to 20% of patients with PCNSL are 80 years
of age or older, little data exist with regard to optimal treatment of this patient
population and they often do not qualify for clinical trials. In addition, elderly patients
have a poorer rate of complete and partial response and increased risk of toxicity when
treated with standard chemotherapy regimens. Though a consensus does not exist, radiotherapy
alone is often used in these patients to minimize toxic effects of more aggressive
chemotherapies.
The Optune TTF device has proven effective in treating high-grade gliomas and is currently
being investigated to treat meningiomas and metastatic lesions in the brain as well as other
tumor types elsewhere in the body. It is generally well tolerated with no known systemic side
effects, producing only an occasional local skin reaction. The mechanism of action is
independent of tumor type and therefore may be effective in treating lymphoma as well.
tolerate standard chemotherapy for PCNSL treated with WBXRT together with Optune-TTF to those
treated with whole-brain radiotherapy alone.
Standard treatment of primary central nervous system lymphoma (PCNSL) for patients with good
performance status involves high-dose methotrexate-based chemotherapy regimens and
whole-brain radiation therapy (WBXRT). Although up to 20% of patients with PCNSL are 80 years
of age or older, little data exist with regard to optimal treatment of this patient
population and they often do not qualify for clinical trials. In addition, elderly patients
have a poorer rate of complete and partial response and increased risk of toxicity when
treated with standard chemotherapy regimens. Though a consensus does not exist, radiotherapy
alone is often used in these patients to minimize toxic effects of more aggressive
chemotherapies.
The Optune TTF device has proven effective in treating high-grade gliomas and is currently
being investigated to treat meningiomas and metastatic lesions in the brain as well as other
tumor types elsewhere in the body. It is generally well tolerated with no known systemic side
effects, producing only an occasional local skin reaction. The mechanism of action is
independent of tumor type and therefore may be effective in treating lymphoma as well.
Inclusion Criteria:
- Histological de novo diagnosis of PCNSL
- Tumor located in the supra-tentorial brain region
- Karnofsky performance score of 70 or above
- Ineligible for chemotherapy due to age or other co-morbidities
- Life expectancy of at least 3 months
- Patient has a caretaker willing to assist with study compliance
- Patient is able to provide written consent on their own behalf
Exclusion Criteria:
- Second or subsequent recurrence of PCNSL
- Patient wishes to receive systemic treatment
- Implanted electronic medical device in the brain (deep brain stimulator, vagus nerve
stimulator, programmable shunt, etc.)
- Skull defect without replacement
- Prior radiation, surgery, or chemotherapy for PCNSL within the 4 weeks prior to
enrollment
- Patient unable to comply with Optune device treatment or the study follow- up schedule
- Active participation in another therapeutic clinical trial
- Patient unable to provide written consent on their own behalf
We found this trial at
2
sites
Saint Luke's Hospital, Kansas City Saint Luke's Hospital is a not-for-profit tertiary referral center committed...
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