Proton Beam Radiation Therapy for Central Nervous System (CNS) Germ Cell Tumors



Status:Active, not recruiting
Conditions:Cancer, Neurology
Therapuetic Areas:Neurology, Oncology
Healthy:No
Age Range:3 - 25
Updated:11/11/2018
Start Date:June 2010
End Date:March 2020

Use our guide to learn which trials are right for you!

Phase II Study of Proton Radiation Therapy for CNS Germ Cell Tumors: Evaluation of Acute and Late Side Effects

The purpose of this research study is to determine if radiation using proton beam therapy
will kill the germ cell tumor in the participant's central nervous system. This type of
radiation has been used previously on many patients with different types of cancers. There
are two types of external radiation treatments, proton beam and photon beam. In this study we
will be examining the effects of proton beam radiation therapy. Studies have suggested that
this kind of radiation can spare normal tissue more than photon radiation therapy. The
physical characteristics of proton beam radiation let the doctor safely increase the amount
of radiation delivered to the tumor. We believe that proton beam therapy will potentially
reduce side effects that participants would normally experience with photon radiation
therapy.

- Before participants begin radiation therapy they will have scans done to prepare them
for radiation treatment. Doctors will use the information gathered from these scans to
plan the best way to deliver radiation to the tumor.

- Participants will receive treatment as an outpatient at the Francis H. Burr Proton
Center located at the Massachusetts General Hospital.

- Not everyone who participates in this study will receive the same amount of proton
radiation therapy. The length of time and amount of radiation that the participant will
receive will depend on the type of germ cell tumor they have and the stage of the their
disease.

- Radiation treatment will be given once a day, 5 days a week (Monday-Friday), for 4-8
weeks depending on the condition of the participant's disease.

- During each week of proton radiation therapy, participants will have a physical exam and
be asked questions about their general health and any problems they might be
experiencing.

Inclusion Criteria:

- Histologically confirmed germ cell tumor or elevated AFP or B-HCG in the setting of
radiographic disease consistent with a germ cell tumor. Disease must be confined to
the central nervous system.

- Participants do not need to have measurable disease. Most patients will not have
measurable disease at the time of treatment.

- 3 years of age or older and 25 years of age or younger at the time of diagnosis
because this study evaluates this disease entity in the pediatric population which may
differ from the adult population.

- Life expectancy of greater than 12 months.

- ECOG performance status of 0, 1 or 2

- Baseline MRI of the brain and spinal axis with gadolinium and prior to any
chemotherapy is required. If surgical resection is performed a post-operative MRI is
required. If the patient receives chemotherapy prior to radiation, a post-chemotherapy
MRI of the brain is required. If spinal involvement was seen on initial MRI and prior
to chemotherapy, a MRI of the spine is required after chemotherapy and prior to
radiation.

- Serum and lumbar CSF must be obtained to evaluate for alpha fetoprotein (AFP) and beta
human chorionic gonadotropin (HCG). This is needed to stratify patients into pure GCT
and NGGCT.

- Women of child-bearing potential and men must agree to use adequate contraception
prior to study entry and for the duration of study participation.

Exclusion Criteria:

- Patients will be ineligible if any prior therapeutic radiation therapy > 200 cGy has
been delivered to the central nervous system.

- Patients will be ineligible if chemotherapy was completed greater than 1 year from the
planned start date of radiation therapy or if the patient is referred for radiation
therapy after a relapse following a regimen with chemotherapy alone.

- Individuals with a history of a different malignancy are ineligible except for the
following circumstances: Disease-free for at least 5 years and are deemed by the
investigator to be at low risk for recurrence of that malignancy. Individuals
diagnosed and treated within the past 5 years for cervical cancer in situ and basal
cell or squamous cell carcinoma of the skin.

- Pregnant females
We found this trial at
2
sites
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Shannon MacDonald, MD
Phone: 617-643-7250
?
mi
from
Boston, MA
Click here to add this to my saved trials
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Karen Marcus, MD
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
?
mi
from
Boston, MA
Click here to add this to my saved trials