Safety and Dose-Finding Study of TM-601 in Adults With Recurrent Malignant Glioma

Status unconfirmed · Phase 1

Conditions studied: Malignant Glioma, Glioblastoma Multiforme, GBM, Astrocytoma, Oligodendroglioma

In brief

The purpose of this study is to evaluate the safety and biologically active dose of TM-601 in adult patients with recurrent malignant glioma.

Key facts

Study ID

NCT00591058

Run by

TransMolecular

People needed

36

Starts

2008-02-01

Expected to finish

2010-02-01

Last updated by the study team

2009-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients Must:
• Have histologically proven malignant glioma (anaplastic astrocytoma, anaplastic oligodendroglioma or glioblastoma multiforme) which is progressive or recurrent after external beam radiation therapy (to at least 50 Gy) ± chemotherapy. Patients with previous low grade glioma who progressed after radiotherapy ± chemotherapy and are biopsied and found to have a high grade glioma are eligible.
• Be ≥18 years of age.
• Have a baseline Karnofsky Performance status of ≥60%
• Have a Mini Mental State Exam score ≥ 19.
• Have a life expectancy, based on the Investigator's judgment, of >3 months.
• On screening ECG, have a QTc interval of <450 ms.
• If taking steroids, be on a dose that is stable for at least 5 days prior to the imaging dose.
• Have recovered from the toxicity of all previous therapy prior to enrollment. If the patient has undergone recent major surgery, an interval of at least 3 weeks must have elapsed between the surgery and the date of the imaging dose.
• Have adequate organ and marrow function as defined below:
• hemoglobin >9.0g/dL absolute neutrophil count >1,500 mm3 platelet count >100,000 mm3 prothrombin time <1.5 ULN partial thromboplastin time (PTT) <1.5 ULN total bilirubin < 2.0 mg/dL AST(SGOT)/ALT(SGPT) <5 x institutional ULN creatinine (serum) ≤2.0 mg/dL*
• If serum creatinine is >2.0 then creatinine clearance must be ≥60 ml/min
• Have a negative serum and urine pregnancy test within 14 days of study drug administration, if female and of child bearing potential.
• Agree to use an effective form of contraception to avoid pregnancy, if fertile (applicable to both male and female patients).
• Agree to refrain from nursing, if female.
• Have signed and dated written informed consent.
• Be able to comply with treatment plan, study procedures and follow-up examinations.

You may not qualify if…

• Patients may NOT:
• Have a serious concurrent infection or medical illness which would jeopardize the ability of the patient to receive the treatment outlined in this protocol with reasonable safety. (Examples of medical illnesses are [but not limited to] the following: uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.)
• Have a prior malignancy with less than 5-year disease free interval, except for adequately treated basal cell or squamous cell carcinoma of the skin, or in situ cancer of the cervix.
• Be pregnant or breast-feeding.
• Have received radiation treatments ≤ 3 months from time of first study drug administration.
• Have received any cytotoxic chemotherapy, whether conventional or investigational, ≤ 4 weeks prior to enrollment in this study (6 weeks for mitomycin-C or nitrosoureas).
• Have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to 131I-TM-601 e.g. iodine or iodine-containing drugs.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Northwestern University — Chicago, Illinois, United States
• Washington University — St Louis, Missouri, United States
• Columbia University — New York, New York, United States
• Wake Forest University — Winston-Salem, North Carolina, United States
• University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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