Choroid Plexus Tumors Clinical Trial
Official title:
A Pilot Study Evaluating the Feasibility of an Intercontinental Phase III Chemotherapy Study for Patients With Choroid Plexus Tumors
The goal of this clinical research study is to compare carboplatin to cyclophosphamide when
given with etoposide, vincristine, and radiation therapy in the treatment of choroid plexus
tumors. The safety of these 2 combination therapies will also be compared.
Objectives:
OVERALL AIM:
To improve choroid plexus tumor treatment through better understanding of the tumor biology
and through increased knowledge about the benefit of specific treatment elements.
Specific Objectives:
The study will have a prephase to evaluate the feasibility of the following randomized study
(main phase).
Pre-Phase (completed 2005) Primary Specific Objective:
To determine the number of patients accountable per year for randomization in a worldwide
study.
Secondary Specific Objective:
To measure the number of drop outs and to describe the toxicity of the chemotherapy.
Main Phase (started in 2006) Primary Specific Objective:
To compare the survival times after cyclophosphamide based treatment with the survival times
after carboplatin based treatment in choroid plexus tumor patients.
Main Phase Secondary Specific Objectives:
1. To compare the resectability of choroid plexus tumors after two blocks of
cyclophosphamide based treatment with the resectability after two blocks of carboplatin
based treatment.
2. To compare response rates of incompletely resected choroid plexus tumors to two blocks
of cyclophosphamide based treatment with the response rates after two blocks of
carboplatin based treatment.
3. To determine the prognostic relevance of histological atypia and SV40 in choroid plexus
tumors.
Tumors of the choroid plexus epithelium are rare. Participants in this study will have
surgery to remove as much of the brain tumor as possible. Taking as much of the tumor out
during surgery is generally believed to have the best result for this disease. Some
participants may even have a second surgery to remove more tumor if thought necessary.
After the tumor surgery, exact treatment for each participant in this study will depend on
how much of the tumor is removed during surgery and the way the tumor tissue looks under a
microscope. Some participants will not require additional treatment because most or all of
the tumor has been taken out. Those participants will still be on study, but they will only
have observation and not receive additional treatment. Those that require additional
treatment will be randomly assigned (as in the toss of a coin) to one of 2 treatment groups
with an equal chance of being assigned to either group.
Chemotherapy (treatment with anti-cancer drugs) will be given as part of treatment for
participants whose tumors are not completely removed surgically. Participants in one group
will receive carboplatin plus etoposide, vincristine, and radiation therapy . Participants in
the other group will receive cyclophosphamide plus etoposide, vincristine, and radiation
therapy. Among all the known drugs for cancer, etoposide, vincristine, cyclophosphamide, and
platinum drugs are the most effective against brain tumors. Carboplatin will be used because
fewer side effects related to hearing should occur later on. This study also uses radiation
therapy after surgery for children younger than 3 years old. Normally, chemotherapy has been
used to delay radiation therapy until the child was older because of concerns about side
effects. This change has been made because of the poor results achieved when chemotherapy was
used to delay radiation therapy.
Chemotherapy is the one and only additional treatment that participants under 3 years of age
can receive in this study. After the first 2 cycles, response will be evaluated, including
all exams done at screening before you continue on treatment, if needed. Further surgery will
be considered after these exams. If both you and your doctor choose to consider further
surgery and agree for the procedure to be the next appropriate step, you may undergo a second
surgery to remove anymore remaining tumor. After the second surgery, the chemotherapy will be
again continued on the same schedule for 4 more cycles. If you did not require further
surgery, you will continue on with the chemotherapy as previously planned.
For participants older than 3 years of age, radiation therapy will be a part of the
treatment. It will be given after the second cycle of chemotherapy. Participants will receive
radiation once per day, five days per week, over a period of about 6 weeks. Most of the
participants do not need to stay in the hospital during this time. This will be followed by 6
more cycles of chemotherapy. After 6 cycles of chemotherapy, further surgery will again be
considered. While on radiation treatment, you will have blood (about 2 teaspoons) drawn for
routine tests 2 times a week. Before and after the finish of radiation, another blood test
(2-3 teaspoons) will be taken to monitor the kidney and liver function, as well as to measure
levels of hormones. You will have a physical exam, and blood (about 2 teaspoons) will be
drawn for routine tests before each cycle of treatment.
Participants in the carboplatin group will receive etoposide over 1 hour on Days 1-5,
carboplatin over 2 hours on Days 2 and 3, and vincristine over 15 minutes on Day 5. This will
be repeated every 4 weeks for 24 weeks. Each period of 4 weeks is considered 1 cycle of
treatment.
Participants in the cyclophosphamide group will receive etoposide over 1 hour on Days 1-5,
cyclophosphamide over 1 hour on Days 2 and 3, and vincristine over 15 minutes on Day 5. This
will be repeated every 4 weeks for 6 cycles (24 weeks) of treatment. Mesna, a drug to protect
the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose
of cyclophosphamide.
The chemotherapy given in this study can cause your white blood cell count to be too low.
White blood cells are infection-fighting cells. If the white blood cell count is low for too
long, participants in both groups may be given a drug called G-CSF (filgrastim). Filgrastim
is a growth factor naturally produced in the body to increase the production of white blood
cells. Filgrastim will be given as a shot under the skin starting at Day 9 after starting the
chemotherapy.
The total length of treatment that you can receive will be 7 months, if you are able to
complete all the cycles of the additional treatment. You will be taken off study if the
disease gets worse or intolerable side effects occur, and your doctor will discuss other
treatment options with you.
After completing treatment, there will be follow-up visits every 3 months for the first year.
Every 6 months there will still be visits with the doctor until 4 years after completing
treatment. You will continue to have follow-up visits every year after that to monitor for
any signs of the disease coming back, or for as long as you would agree to allow follow-up
visits. At each visit, you will have routine blood tests (about 2-3 teaspoons), checking of
hormone levels, measurement of growth, and a hearing test. The effects of
radiation/chemotherapy on your brain function, your ability to learn, and your quality of
life will be measured. You will have a MRI of the brain, all known metastatic sites, and of
the spine. Your body height and body weight will be measured. About 2 teaspoons of blood will
be drawn for routine tests. Your urine will be tested for the presence of blood. You will
have a spinal tap to look for cancer cells in the spinal fluid. Your hormone levels will also
be taken to see if there are any signs of metabolic disorder and growth deficiency. This will
be done with the other blood test and will not require any more extra blood samples from you.
This is an investigational study. All of the drugs used in this study are FDA approved and
are commercially available. Their use together in this study is experimental. A total of up
to 100 patients will take part in this multicenter study. Up to 5 will be enrolled here at M.
D. Anderson.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT01014767 -
Intercontinental Multidisciplinary Registry and Treatment Optimization Study for Choroid Plexus Tumors
|
Phase 3 | |
| Recruiting |
NCT03173950 -
Immune Checkpoint Inhibitor Nivolumab in People With Recurrent Select Rare CNS Cancers
|
Phase 2 |