Brain and Central Nervous System Tumors Clinical Trial
Official title:
A Randomized Prospective Two Arm Clinical Trial of High Light Dose And Low Light Dose PDT in the Treatment of Recurrent Malignant Supratentorial Gliomas Using Porfimer Sodium [Photofrin]
RATIONALE: Photodynamic therapy uses a drug, such as porfimer sodium, that becomes active
when it is exposed to a certain kind of light. When the drug is active, tumor cells are
killed. Giving photodynamic therapy after surgery may kill any remaining tumor cells.
PURPOSE: This randomized clinical trial is studying two different light doses of
photodynamic therapy using porfimer sodium to compare how well they work in treating
patients who are undergoing surgery for recurrent malignant astrocytoma.
OBJECTIVES:
- Compare survival of patients undergoing surgical resection for recurrent high-grade
malignant supratentorial astrocytoma treated with intraoperative high vs low light dose
photodynamic therapy using porfimer sodium.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center. Patients are randomized to 1 of 2 treatment arms.
All patients receive porfimer sodium IV. One day later, patients undergo craniotomy and
tumor resection.
- Arm I: During surgery, patients receive low light dose photodynamic therapy.
- Arm II: During surgery, patients receive high light dose photodynamic therapy. After
completion of study treatment, patients are followed at 1 day, 6 weeks, and 3 months
and then every 3 months for up to 2 years.
PROJECTED ACCRUAL: Approximately 120 patients will be accrued for this study within 4-5
years.
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT00006080 -
Fenretinide in Treating Patients With Recurrent Malignant Glioma
|
Phase 2 | |
| Recruiting |
NCT00887146 -
Radiation Therapy With Concomitant and Adjuvant Temozolomide Versus Radiation Therapy With Adjuvant PCV Chemotherapy in Patients With Anaplastic Glioma or Low Grade Glioma
|
Phase 3 | |
| Suspended |
NCT00935090 -
3'-Deoxy-3'-[18F] Fluorothymidine PET Imaging in Patients With Cancer
|
N/A | |
| Completed |
NCT00621686 -
Bevacizumab and Sorafenib in Treating Patients With Recurrent Glioblastoma Multiforme
|
Phase 2 | |
| Terminated |
NCT00227032 -
Erlotinib in Treating Patients With Progressive Glioblastoma Multiforme
|
Phase 1 | |
| Completed |
NCT00112502 -
Temozolomide Alone or in Combination With Thalidomide and/or Isotretinoin and/or Celecoxib in Treating Patients Who Have Undergone Radiation Therapy for Glioblastoma Multiforme
|
Phase 2 | |
| Terminated |
NCT00243022 -
Dietary, Herbal and Alternative Medicine in Glioblastoma Multiforme
|
Phase 2 | |
| Active, not recruiting |
NCT00087815 -
Hyperbaric Oxygen Therapy in Treating Patients With Radiation Necrosis of the Brain
|
N/A | |
| Active, not recruiting |
NCT00278278 -
Combination Chemotherapy and Radiation Therapy With or Without Methotrexate in Treating Young Patients With Newly Diagnosed Gliomas
|
Phase 3 | |
| Completed |
NCT00416819 -
Combination Chemotherapy and Rituximab in Treating Patients With Newly Diagnosed Primary CNS Lymphoma
|
N/A | |
| Completed |
NCT00052286 -
Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
|
N/A | |
| Completed |
NCT00006093 -
EMD 121974 in Treating Patients With Progressive or Recurrent Glioma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT00004129 -
Phosphorus 32 in Treating Patients With Glioblastoma Multiforme
|
Phase 1 | |
| Completed |
NCT00004212 -
DX-8951f in Treating Children With Advanced Solid Tumors or Lymphomas
|
Phase 1 | |
| Completed |
NCT00003417 -
Computer Planned Radiation Therapy Plus Chemotherapy in Treating Patients With Glioblastoma Multiforme
|
Phase 1/Phase 2 | |
| Completed |
NCT00008008 -
Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Malignant Glioma
|
Phase 2 | |
| Completed |
NCT00003464 -
Temozolomide in Treating Adults With Newly Diagnosed Primary Malignant Glioblastoma Multiforme
|
Phase 2 | |
| Completed |
NCT00003020 -
LMB-7 Immunotoxin in Treating Patients With Leptomeningeal Metastases
|
Phase 1 | |
| Completed |
NCT00003173 -
High-Dose Thiotepa Plus Peripheral Stem Cell Transplantation in Treating Patients With Refractory Solid Tumors
|
Phase 2 |