Phase I/II Study of Intratumoral Injection of DTI-015 Prior to Tumor Resection in Patients With Recurrent Malignant Glioma or Metastatic Neoplasm to Brain

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed recurrent supratentorial malignant glioma with clear
evidence of progression by MRI

- Glioblastoma multiforme

- Anaplastic ependymoma

- Anaplastic astrocytoma

- Anaplastic oligodendroglioma OR

- Metastatic tumor to the brain other than melanoma

- Planned resection of tumor (must be first surgery for recurrent disease)

- Tumor volume of each tumor component or residual tumor must be at least 4 cm3 and no
greater than 33.4 cm3

- Tumor shape and surrounding structure(s) unlikely to cause an irregular distribution
of the injected study drug

- Tumor is spherical, spheroid, or ovoid

- No tumors shaped into 3 or more components (e.g., multicentric or
multilobulated)

- No tumors extending into the ventricular system

- Tumor has an intact stroma (i.e., tumor mass not partially incised or punctured)

- Central necrosis and/or central cystic areas allowed if an enhancing rim with a
thickness of more than 5 mm is present

- No tumors in the following locations of the brain:

- Brainstem (pons or medulla)

- Midbrain (mesencephalon)

- Primary sensorimotor cortex in the dominant hemisphere

- Within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial
nerve

PATIENT CHARACTERISTICS:

Age:

- 18 to 75

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

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

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

- No evidence of bleeding diathesis

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

- SGOT and SGPT no greater than 2.5 times normal

Renal:

- Creatinine no greater than 2.0 mg/dL OR

- Creatinine clearance at least 40 mL/min OR

- BUN no greater than 30 mg/dL

Other:

- No active uncontrolled infection

- Afebrile (37.5 degrees C) unless fever due to tumor

- No other unstable or severe medical condition

- No complicating medical or psychiatric problem that would preclude study

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- At least 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas,
mitomycin, or Gliadel wafers) and recovered

- No anti-tumor chemotherapy within 12 weeks after study drug unless tumor volume
increases by more than 25% by MRI

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 4 weeks since prior radiotherapy and recovered

- No prior intracranial brachytherapy

- No anti-tumor radiotherapy within 12 weeks after study drug unless tumor volume
increases by more than 25% by MRI

Surgery:

- See Disease Characteristics

- Prior surgery allowed

- No anti-tumor surgery within 12 weeks after study drug

Other:

- No concurrent anticoagulants

- No other concurrent investigational agents