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

NCT00038441 | Completed Phase 1

• 1 other identifier: ID95-115
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Glioma; Brain Neoplasms

Keywords

Malignant Glioma

Outcome Measures

Primary Outcomes (1)

• Maximum Dose of DTI-015

  Every 2-4 weeks

Study Arms (1)

DTI-015

EXPERIMENTAL

Drug: DTI-015

Interventions

DTI-015 DRUG

DTI-015 injected through a catheter into center of brain tumor.

DTI-015

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Direct Therapeutics: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Glioma; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Samuel J. Hassenbusch, MD, PHD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2002
• First Posted: May 31, 2002
• Study Start: September 1, 1995
• Primary Completion: February 1, 2003
• Study Completion: August 1, 2005
• Last Updated: October 31, 2018

Record last verified: 2018-10

Locations

US (1)