Surgery, Radiation Therapy, and Chemotherapy With or Without Photodynamic Therapy in Treating Patients With Newly Diagnosed or Recurrent Malignant Supratentorial Gliomas

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Colorado Health Foundation
• Treatments: Carmustine; Dihematoporphyrin Ether; Lomustine; Procarbazine; Trioxsalen

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed newly diagnosed or recurrent supratentorial glioblastoma or malignant astrocytoma

• Grade 3 or 4 astrocytoma as defined by the Daumas-Duport classification

• Suitable for radical resection on the basis of imaging studies

• Patients with recurrent disease must have failed surgery and radiotherapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100% for newly diagnosed tumor

• Karnofsky 70-100% for recurrent tumor

Life expectancy:

• At least 3 months

Hematopoietic:

• Recurrent tumor:

• WBC at least 2,000/mm^3

• Platelet count at least 80,000/mm^3

Hepatic:

• Recurrent tumor:

• PT/PTT no greater than 1.5 times upper limit of normal (ULN)

• Bilirubin and LFTs less than 2 times ULN

• Alkaline phosphatase no greater than 3 times ULN

• GGT no greater than 3 times ULN

Renal:

• Creatinine no greater than 2 mg/dL

Other:

• Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• Not specified

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• No prior cranial radiotherapy for newly diagnosed tumor

Surgery:

• See Disease Characteristics