View Clinical Trial (Medical Research Study)
Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study
| City: |
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Milwaukee |
| State: |
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Wisconsin |
| Zip Code: |
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53226 |
| Conditions: |
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Brain and Central Nervous System Tumors - Metastatic Cancer |
| Purpose: |
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RATIONALE: Photodynamic therapy uses light and photosensitizing drugs to kill tumor cells
and may be an effective treatment for refractory brain tumors.
PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic
therapy using porfimer sodium in treating patients with refractory brain tumors, including
astrocytoma, ependymoma, and medulloblastoma.
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| Study Summary: |
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OBJECTIVES:
- Determine the maximum tolerated dose of benzoporphyrin monoacid ring A in patients with
refractory brain tumors undergoing cavitary photoillumination photodynamic therapy.
- Determine the effect of this regimen on neurotoxicity, clinical state, imaging changes,
and survival of these patients.
OUTLINE: This is a dose-escalation study. Patients are stratified according to tumor
location (posterior fossa tumors vs all other brain tumors).
Patients receive benzoporphyrin monoacid ring A (BPD-MA) IV preoperatively. Approximately 3
hours after BPD-MA administration, patients undergo craniotomy with photoillumination of the
tumor. Patients with tumors greater than 2 cm in diameter also undergo gross tumor
resection.
Cohorts of 3-6 patients receive escalating doses of BPD-MA until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose immediately preceding that at which 2 of
3 or 2 of 6 patients experience dose-limiting toxicity. Three additional patients are
treated at the MTD.
Patients are followed at 4 and 6 weeks, every 3 months for 1 year, every 6 months for 1
year, and then annually thereafter.
PROJECTED ACCRUAL: A minimum of 24 patients will be accrued for this study within 3 years.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- Diagnosis of supratentorial or infratentorial brain tumor
- Localized, non-disseminated
- Primary tumor or solitary metastasis
- Recurrent or progressive
- Unresectable
- Negative CSF
- Must have failed standard therapy including radiotherapy
- Measurable disease as evidenced by CT scan or MRI
- Single or multiple masses accessible to light administration
PATIENT CHARACTERISTICS:
Age:
- 3 to 70
Performance status:
- Not specified
Life expectancy:
- At least 2 months
Hematopoietic:
- Absolute neutrophil count at least 1,000/mm3
- May transfuse platelets
Hepatic:
- PT and PTT normal
Renal:
- Not specified
Other:
- Not pregnant
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- At least 6 weeks since prior chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior brachytherapy
Surgery:
- See Disease Characteristics
Other:
- No other concurrent antitumor therapy
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| NCT ID: |
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NCT00002647 |
| Primary Contact: |
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Study Chair
Harry T. Whelan, MD
Medical College of Wisconsin
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| Backup Contact: |
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N/A |
| Location Contact: |
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Milwaukee, Wisconsin 53226
United States
Clinical Trials Office - Medical College of Wisconsin Cancer C
Phone: 414-805-4380
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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