Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer, Brain Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/1/2018 |
| Start Date: | September 2002 |
| End Date: | September 2019 |
A Phase II Trial of Intensive Chemotherapy and Autotransplantation for Patients With Newly Diagnosed Anaplastic Oligodendroglioma
The purpose of this study is to see how effective treatment of high doses of chemotherapy is
for your tumor. We will also be looking at the side effects and risks of this treatment.
You will receive very high doses of chemotherapy. High doses of chemotherapy can destroy
tumor cells, but it can also destroy normal bone marrow cells. These cells produce white
blood cells (which fight infection), red blood cells (which carry oxygen) and platelets
(which allow your blood to clot). With too few of these cells there is a serious risk of
infection and bleeding.
Therefore, before treatment begins, we will collect some of your own blood cells, called
peripheral blood progenitor cells (PBPCs). These cells help create new blood cells. The PBPCs
are frozen and saved while you are being treated. Then at the end of treatment, your PBPCs
are thawed and given back to you. These healthy PBPCs will replace the blood cells that the
high dose chemotherapy destroys and allow your bone marrow to recover and produce blood
cells. In a prior study we treated 69 patients in a similar way. More than half were able to
avoid or delay brain radiation. This new study will use a different high dose chemotherapy
regimen.
for your tumor. We will also be looking at the side effects and risks of this treatment.
You will receive very high doses of chemotherapy. High doses of chemotherapy can destroy
tumor cells, but it can also destroy normal bone marrow cells. These cells produce white
blood cells (which fight infection), red blood cells (which carry oxygen) and platelets
(which allow your blood to clot). With too few of these cells there is a serious risk of
infection and bleeding.
Therefore, before treatment begins, we will collect some of your own blood cells, called
peripheral blood progenitor cells (PBPCs). These cells help create new blood cells. The PBPCs
are frozen and saved while you are being treated. Then at the end of treatment, your PBPCs
are thawed and given back to you. These healthy PBPCs will replace the blood cells that the
high dose chemotherapy destroys and allow your bone marrow to recover and produce blood
cells. In a prior study we treated 69 patients in a similar way. More than half were able to
avoid or delay brain radiation. This new study will use a different high dose chemotherapy
regimen.
Inclusion Criteria:
- Pathologic evidence of an anaplastic oligodendroglioma. For this study, World Health
Organization classification criteria will be used. Central pathology review must take
place prior to high-dose therapy but need not occur prior to study entry and induction
therapy.
- Pathologic evidence of an anaplastic mixed glioma (i.e. oligoastrocytoma). Again,
histopathologic diagnosis will be made using World Health Organization classification
criteria. To qualify as a mixed tumor there must be a minimum of 25% oligodendroglial
element. Central pathology review must take place prior to high-dose therapy but need
not occur in advance of enrollment or induction therapy.
- The diagnostic surgical procedure may have been a complete resection, partial
resection, or biopsy.
- Karnofsky performance status > or equal to 60.
- Granulocyte count > or equal to 1.5 X 109/L.
- Platelet count > or equal to 100 X 109/L
- SGOT < than or equal to 2X upper limit of normal.
- Serum creatinine < than or equal to 1.5X upper limit of normal
- Bilirubin < than or equal to 1.5X upper limit of normal
- All patients must sign written informed consent.
Exclusion Criteria:
- Systemic or leptomeningeal metastases (excluding contiguous leptomeninges)
- Prior cranial radiotherapy or systemic chemotherapy
- Other concurrent malignancy (with the exception of cervical carcinoma in situ or basal
cell carcinoma of the skin) or serious illness if this would interfere with the
prescribed treatment.
- Pregnant or lactating women
- Refusal to use effective contraception
We found this trial at
3
sites
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Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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