SU5416 in Treating Patients With Recurrent Astrocytoma or Mixed Glioma That Has Not Responded to Radiation Therapy

• Status: Completed
• Trial end date: 2005-09-15
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: SU5416 may stop the growth of astrocytoma or glioma by stopping blood flow to the tumor.

PURPOSE: Phase I/II trial to study the effectiveness of SU5416 in treating patients who have recurrent astrocytoma or mixed glioma that has not responded to previous radiation therapy.

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

Details

• Lead Sponsor: North American Brain Tumor Consortium; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: National Cancer Institute (NCI)
• Treatments: Semaxinib

Criteria

DISEASE CHARACTERISTICS:

• Histologically proven supratentorial malignant primary glioma, including:

• Glioblastoma multiforme

• Anaplastic astrocytoma

• Anaplastic oligodendroglioma

• Anaplastic mixed oligoastrocytoma

• Malignant astrocytoma not otherwise specified

• Benign or malignant meningiomas, including brain and spinal meningiomas

• Patients with meningiomas are excluded from phase II portion of study

• Must have shown unequivocal evidence of tumor recurrence or progression by CT scan or MRI

• Must have failed prior radiotherapy

• Must have prestudy contrast MRI or contrast CT scan of brain on stable steroid dose within the past 14 days

• Must be on stable (unchanged) dose of steroids for at least 5 days before scans

• Phase II:

• Must have completed radiotherapy at least 2 months prior to enrollment

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 60-100%

Life expectancy:

• More than 8 weeks

Hematopoietic:

• WBC at least 2,300/mm^3

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

• Hemoglobin at least 8 g/dL (transfusion allowed)

Hepatic:

• SGOT less than 2.5 times upper limit of normal

• Bilirubin normal

• No significant active hepatic disease

Renal:

• Creatinine less than 1.5 mg/dL OR

• Creatinine clearance at least 60 mL/min

• No significant active renal disease

Cardiovascular:

• No uncompensated coronary artery disease on ECG or physical examination

• No history of myocardial infarction or severe/unstable angina within the past 6 months

• No deep venous or arterial thrombosis within the past 3 months

Pulmonary:

• No pulmonary embolism within the past 3 months

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception during and for 2 months after study

• No other serious concurrent illness

• No significant active psychiatric disease

• No diabetes mellitus with severe peripheral vascular disease

• No other malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

• No serious active infection

• No other concurrent disease that would obscure toxic effects or dangerously alter drug metabolism

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• At least 3 weeks since prior biologic therapy (e.g., interferon) and recovered

• No concurrent immunotherapy

Chemotherapy:

• Phase I:

• No more than 2 prior chemotherapy regimens for recurrent disease

• Phase II:

• No more than 1 prior chemotherapy regimen for recurrent disease

• At least 2 weeks since prior vincristine

• At least 6 weeks since prior nitrosoureas

• At least 3 weeks since prior procarbazine

• Recovered from prior chemotherapy

• No concurrent chemotherapy

Endocrine therapy:

• See Disease Characteristics

• At least 3 weeks since prior endocrine therapy (e.g., tamoxifen) and recovered

Radiotherapy:

• See Disease Characteristics

• No concurrent radiotherapy

Surgery:

• Recovered from prior surgery

• Recent prior resection of recurrent or progressive tumor allowed

Other:

• No other concurrent investigational agents