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Sponsored by: |
Colorado Health Foundation |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003788 |
RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known if the addition of photodynamic therapy to combined therapy with surgery, radiation therapy, and chemotherapy is more effective than combined therapy alone for supratentorial gliomas.
PURPOSE: Randomized phase III trial to study the effectiveness of surgery, radiation therapy, and chemotherapy with or without photodynamic therapy in treating patients who have newly diagnosed or recurrent malignant supratentorial gliomas.
Condition | Intervention | Phase |
---|---|---|
Brain and Central Nervous System Tumors |
Drug: carmustine Drug: lomustine Drug: porfimer sodium Drug: procarbazine hydrochloride Procedure: neoadjuvant therapy Procedure: surgical procedure Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Prospective Clinical Trials in the Use of Photodynamic Therapy (PDT) for the Treatment of Malignant Supratentorial Brain Tumors |
Estimated Enrollment: | 270 |
Study Start Date: | April 1998 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter, two part study. Patients are stratified according to clinical center.
Newly diagnosed patients (Study 1)
Patients are randomized to receive either high light dose photodynamic therapy (arm I) or no photodynamic therapy (arm II):
Recurrent tumor patients (Study 2)
Patients receive Photofrin IV one day prior to surgery. Craniotomy and tumor resection are performed.
Patients are followed on both studies at 4 weeks postsurgery, then every 3 months until death or for 1 year after study closure.
PROJECTED ACCRUAL: A minimum of 150 patients with newly diagnosed tumor will be accrued for this study within 4 years (Study 1). A maximum of 120 patients with recurrent disease will be accrued within 4.5 years (Study 2)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed or recurrent supratentorial glioblastoma or malignant astrocytoma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Recurrent tumor:
Hepatic:
Recurrent tumor:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United States, Colorado | |
Rocky Mountain Neurological Associates | |
Englewood, Colorado, United States, 80110 | |
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263-0001 | |
United States, Pennsylvania | |
Western Pennsylvania Hospital | |
Pittsburgh, Pennsylvania, United States, 15224 | |
Canada, Ontario | |
St. Michael's Hospital-Annex | |
Toronto, Ontario, Canada, M5B 1A6 |
Study Chair: | Fred W. Hetzel, PhD, JD | Colorado Health Foundation |
Study ID Numbers: | CDR0000066927, HEALTHONE-43892, HEALTHONE-1A, HEALTHONE-CA43892, RPCI-DS-9802, NCI-V99-1525 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003788 History of Changes |
Health Authority: | United States: Federal Government |
recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult giant cell glioblastoma adult gliosarcoma |
Glioblastoma Astrocytoma Carmustine Lomustine Central Nervous System Neoplasms Recurrence Brain Neoplasms Photosensitizing Agents Radiation-Sensitizing Agents |
Dihematoporphyrin Ether Antineoplastic Agents, Alkylating Glioma Procarbazine Gliosarcoma Trioxsalen Alkylating Agents Nervous System Neoplasms |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Nervous System Diseases Carmustine Central Nervous System Neoplasms Pharmacologic Actions Photosensitizing Agents Neoplasms Neoplasms by Site |
Radiation-Sensitizing Agents Dihematoporphyrin Ether Therapeutic Uses Procarbazine Antineoplastic Agents, Alkylating Trioxsalen Dermatologic Agents Alkylating Agents Nervous System Neoplasms |