Phase I Trial of Intramural Injection of DTI-015 for Recurrent Malignant Gliomas

• Status: Completed
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a clinical research study of a new investigational treatment for cancer called "DTI-015" to be given by intratumoral injection. Intratumoral injection is when drug is injected directly into the tumor. This study will help doctors find out what is the best dose level for DTI-015 and if this treatment can shrink tumors without causing severe side effects. The effects of the drug on the patient's quality of life (how the patient feels and what the patient can do) and their mental functions (reasoning and thinking abilities) will also be studied.

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

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Direct Therapeutics

Criteria

Inclusion Criteria:

• Histologic proof of recurrent previously irradiated supratentorial malignant gliomas including anaplastic astrocytoma, glioblastoma multiforme, anaplastic oligodendroglioma, or anaplastic ependymoma.

• It must be judged that gross total resection of the patient's tumor is not possible or the patient must refuse open resection of tumor. The decision that the tumor cannot be totally resected will be made by and mutually agreed upon by the physician investigators in the study.

• There must be a tumor volume of each tumor component greater than or equal to 0.5 and less than or equal to 15 cubic centimeters.

• The patient must be undergoing a stereotactic biopsy for other clinical reasons than the injection of DTI-015.

• The patient must have a Karnofsky functional status rating greater than or equal to 60.

• The patient must be fully recovered from the acute effects of any prior chemotherapy or radiotherapy.

• The patient must be able to read and fully understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of this study in keeping with the policies of this hospital.

• The patient must be willing and able to comply with the protocol.

• For a female patient of childbearing potential, the patient must not be pregnant as evidenced by a menses in the last 8 weeks or by a negative urine HCG pregnancy test.

Exclusion Criteria:

• Any radiotherapy or chemotherapy during four weeks prior to entering the study.

• Nitrosoureas or mitomycin C during six weeks prior to entering the study.

• Patients with active uncontrolled infection.

• Serious liver or bone marrow disorder - specifically serum bilirubin >2.0 mg%, SGOT >2.5 times normal, SGPT >2.5 times normal, absolute neutrophil count <1500/mm3, platelet count <100,000/mm3.

• Evidence of renal failure (blood creatinine >2.0 mg%, BUN >30 mg/dl or creatinine clearance >40 ml/min

• Evidence of a bleeding diathesis or use of anticoagulant medications.

• Unstable or severe intercurrent medical conditions.

• For females: risk of pregnancy (i.e., unwillingness to use adequate protection to prevent pregnancy), breast feeding a baby during the study period, or lactation.

• Tumors shaped into 3 or more components are excluded. Ovoid-shaped or spherical tumors are allowed. Central necrosis and/or central cystic areas are allowed as long as there is an enhancing rim with a thickness >5 mm.

• Patients who have undergone a partial resection of tumor and who have a cavity inside the residual tumor are excluded.

• Patients with tumors located in the following areas of the brain will be excluded:

brainstem (pons or medulla), midbrain (mesencephalon), primary sensorimotor cortex in the dominant hemisphere, or within 1.5 cm of the optic chiasm, either optic nerve, or any other cranial nerve.

• Patients with tumors extending into the ventricular system will also be excluded.