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- Last updated refers to the date when our listing for each treatment was last updated.
- ID is our internal ID - starting with VT.
- Min Karnofsky is a general guide to how well you have to function to use this treatment
- For trials that also have a NCT number, you can click that number to pop up the listing from the clinicaltrials.gov website.
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Treatment Name: |
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Headstart II A Phase II study of two alternative intensive induction chemotherapy followed by consolidation with myeloablative chemotherapy and autologous stem cell rescue with or without
subsequent radiation therapy for children less than 10 yrs of age newly diagnosed with malignant brain tumors |
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Keywords: |
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Head Start |
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Phase: |
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Phase 2 |
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Treatment ID#s: |
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VT1673
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Age Group: |
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Pediatric Only |
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Min Karnofsky Score: |
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Not Specified |
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Conditions: |
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Newly Diagnosed: ?
Recurrent: ?
Prior Surgery is Sometimes Allowed
Prior Radiation is Sometimes Allowed
Prior Chemotherapy is Sometimes Allowed
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Last Updated: |
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05/01/2006 |
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Tumor Types: |
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Anaplastic Astrocytoma
Brainstem Glioma
Ependyoma
Glioblastoma Multiforme
Gliosarcoma
Medulloblastoma
Oligodendroglioma High Grade
PNET Tumor |
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Comments: |
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The "standard" approach to the treatment of these malignant brain tumors in young children is to administer chemotherapy for periods of between one and two years, with or without the addition of radiation therapy. However, with the "standard" therapy, there is still less than a 20% chance of curing these malignant brain tumors in young children. Furthermore, young children treated with radiation therapy for brain tumors may experience serious and irreversible long-term side-effects from the radiation.
The purpose of this clinical research study is to learn whether intensive chemotherapy for a period of three months, followed by a highly intensive single course of drug treatment with a blood stem cell rescue procedure, can improve the cure rates for young children with these malignant brain tumors and, at the same time, avoid entirely the use of radiation therapy, or at least allow the use of smaller amounts of radiation therapy, thereby decreasing the chances of long-term serious side-effects.
Children less than 10 years old (< 120 months) will be treated on one of two regimens depending on their histologic diagnosis. Regimen A will be used to treat patients with "non-glial" tumors, i.e. primitive neuroectodermal tumors or ependymomas. These patients will have peripheral blood stem cell harvesting, followed by induction chemotherapy. Patients presenting without dissemination will be treated 5 cycles of chemotherapy (cisplatin, vincristine, cyclophosphamide and VP-16) given 21 days apart. Patients with dissemination at presentation will receive the same 4 induction chemotherapy drugs with the addition of methotrexate. These drugs will also be given for 5 cycles, 21 days apart.
Patients with high grade glial tumors or diffuse pontine tumors will be given regimen B induction chemotherapy. These patients will have peripheral blood stem cell (PBSC) harvesting prior to initiation of chemotherapy. Induction chemotherapy will consist of 3 cycles of vincristine, procarbazine, CCNU and carboplatin given 21-28 days apart.
PBSC reinfusion will occur on Day 7 of each cycle.
Following recovery from the final cycle of induction chemotherapy, A or B, the patient will undergo a staging evaluation. If there is no evidence of residual disease, the patient will go to the consolidation phase of the protocol and will not receive radiation therapy. If there is residual disease, second look surgery will be considered. I f surgery takes place and there is no evidence of post-op residual, the patient will proceed to consolidation chemotherapy without radiation therapy. Patients with residual disease will receive radiotherapy following consolidation.
The consolidation phase consists of carboplatin, thiotepa and VP-16, given over a 6 day period, with PBSC reinfusion within 72 hours after the last dose of chemotherapy. Patients with malignant gliomas or unbiopsied pontine gliomas will not receive VP-16 during this phase.
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Treatment Type: |
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Chemotherapy. |
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Contact: |
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Children`s Hospital & Research Center Oakland
Joseph Torkildson, MD, MBA
Director of Neuro-Oncology
747 52nd Street
Oakland, CA 94609
Phone:510-428-3272
Fax: 510-601-3916
Click here to send an email
Website: childrenshospitaloakland.org |
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