Immunotoxin Therapy in Treating Patients With Malignant Glioma

• Status: Completed
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. This may be an effective treatment for malignant glioma.

PURPOSE: Phase I/II trial to study the effectiveness of immunotoxin therapy in treating patients who have malignant glioma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New Approaches to Brain Tumor Therapy Consortium
• Collaborator: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven malignant glioma (grade 3 or 4)

• Anaplastic astrocytoma

• Glioblastoma multiforme

• Malignant mixed oligoastrocytoma

• Must have undergone cranial radiotherapy with tumor dose of at least 48 Gy and at least 12 weeks prior to study

• Must have undergone supratentorial brain tumor surgery or biopsy

• Must have radiographic evidence of recurrent or progressive supratentorial tumor compared with prior study

• Must have solid portion measuring 1.0-5.0 cm in maximum diameter

• Maximum of 1 satellite lesion allowed if separated from the primary mass by less than 3 cm

• No tumor crossing the midline

• No leptomeningeal tumor dissemination

• No impending herniation or spinal cord compression

• No uncontrolled seizures

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• Absolute neutrophil count at least 1,500/mm^3

• Hemoglobin at least 10 g/dL

• Platelet count at least 100,000/mm^3

Hepatic:

• PT and PTT no greater than upper limit of normal (ULN)

• SGOT and SGPT no greater than 2.5 times ULN

• Bilirubin no greater than 2.0 mg/dL

Renal:

• Not specified

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior intralesional chemotherapy for malignant glioma

• At least 3 weeks since other prior chemotherapy (6 weeks since prior nitrosoureas) and recovered

• No concurrent chemotherapy

Endocrine therapy:

• Concurrent corticosteroids allowed, but dose must remain stable or be tapered during study

Radiotherapy:

• See Disease Characteristics

• No prior focal radiotherapy (e.g., any form of stereotactic radiotherapy or brachytherapy) for malignant glioma

Surgery:

• See Disease Characteristics

Other:

• Recovered from any prior therapy

• No other concurrent investigational agent