Trial | NCT00002647  Report issue

Title

Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors
Photodynamic Therapy For Childhood Brain Tumors, A Phase I Study

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    verteporfin ...

  • Study Participants

    24
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.
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.
Study Started
May 31
1994
Last Update
Sep 20
2013
Estimate

Drug verteporfin

Procedure conventional surgery

Criteria 

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
No Results Posted