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Phase I Trial of Intramural Injection of DTI-015 for Recurrent Malignant Gliomas
This study has been terminated.
First Received: May 30, 2002   Last Updated: November 11, 2005   History of Changes
Sponsored by: M.D. Anderson Cancer Center
Information provided by: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00038441
  Purpose

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.


Condition Intervention Phase
Glioma
Brain Neoplasms
Drug: DTI-015
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Estimated Enrollment: 45
Study Start Date: September 1995
Estimated Study Completion Date: August 2005
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00038441

Locations
United States, Texas
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
  More Information

No publications provided

Study ID Numbers: ID95-115
Study First Received: May 30, 2002
Last Updated: November 11, 2005
ClinicalTrials.gov Identifier: NCT00038441     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by M.D. Anderson Cancer Center:
Malignant Glioma

Study placed in the following topic categories:
Neuroectodermal Tumors
Brain Neoplasms
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Central Nervous System Diseases
Central Nervous System Neoplasms
Glioma
Brain Diseases
Nervous System Neoplasms
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nervous System Diseases
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Brain Neoplasms
Neuroectodermal Tumors
Neoplasms
Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Glioma
Neoplasms, Neuroepithelial
Nervous System Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009