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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00114309
Other study ID # TM-601-002
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received June 13, 2005
Last updated April 1, 2009
Start date November 2004
Est. completion date August 2009

Study information

Verified date April 2009
Source TransMolecular
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This drug is being developed to treat a type of brain cancer, glioma. This study was developed to evaluate the safety, time to disease progression and survival rates after treatment.


Description:

This phase II trial was designed in two sequences. The first sequence, which is now complete to accrual was an open-label, dose escalation, multi-dose study and treated 12 evaluable patients with high-grade glioma.

The second sequence is currently open and accruing eligible subjects with high-grade glioma. The trial is an open-label, randomized study and will accrue a total of 54 evaluable patients. Eligible subjects will be randomized to receive either 3 or 6 injections of 131-I labeled TM-601 (131-I-TM-601), in weekly intervals at the dose determined in the first sequence of the trial. Patients will undergo debulking surgery and placement of a ventricular access device into the tumor cavity for administration of 131I-TM-601. Patients who participated in the first sequence are not eligible to participate in the second sequence of the study.

High-grade gliomas include; glioblastoma multiforme, anaplastic astrocytoma, oligoastrocytoma or gliosarcoma.

Patients will undergo follow-up clinical examinations and magnetic resonance imaging (MRI) assessments, at defined intervals, until 12 months after the first study dose.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 66
Est. completion date August 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient must have a histologically confirmed unilateral, supratentorial malignant glioma (grade 3 or 4, anaplastic astrocytoma, gliosarcoma, glioblastoma multiforme or malignant oligoastrocytoma)

- Patient must have glioma progression or recurrence following radiotherapy that was no less than 50 Gy (+/- chemotherapy; +/- surgery)

- Patient must be a candidate for resection of the recurrent tumor (surgical requirements are detailed in the study protocol)

- Imaging must show recurrent, unilateral, supratentorial tumor(s)

- There is no diffuse leptomeningeal disease

- For patients with previous radiosurgery or enhanced radiotherapy, based on neurosurgeon's judgment, the area of enhancement can be removed during the surgery

- Patient must have recovered from toxicity of prior therapy

- Patient must be > 18 years of age.

- Patient has a Karnofsky Performance Status greater than or equal to 60%

- Patient must have a life expectancy of at least 3 months

- Patient has no uncontrolled seizures or other neurological conditions which would interfere with evaluation

- Patient is not currently receiving, or is not anticipated to receive, concomitant anticancer agent(s) during the course of this study

- Patient must have given informed consent

Exclusion Criteria:

- Patient with concurrent malignancy (except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of cervix and/or breast) or patients with prior malignancies that have not been disease-free for five years

- Patient has presence of non-contiguous satellite lesions

- Patient with known allergy to iodine, iodine containing drugs or contrast agent

- Patient with the potential for pregnancy or impregnating their partner and who do not agree to follow an acceptable birth control method to avoid conception

- Pregnant or breast feeding females

- Patient is not maintained on a stable corticosteroid regimen

- New onset of conditions not present prior to surgery (as detailed in Study Protocol) which would make patient an inappropriate study candidate, or as determined by Investigator

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
131-I-TM-601
131I-TM601, in solution, delivered intracavitarily following surgical resection 3 weekly administrations, 0.8 mg TM601 and 40mCi 131Iodine, per dose.
131I-TM601
131I-TM601, in solution, delivered intracavitarily following surgical resection 6 weekly administrations, 0.8 mg TM601 and 40mCi 131Iodine, per dose.

Locations

Country Name City State
United States Emory University Atlanta Georgia
United States Johns Hopkins Medical Center Baltimore Maryland
United States University of Alabama at Birmingham Birmingham Alabama
United States Tufts-New England Medical Center Boston Massachusetts
United States Carolina Neurosurgery and Spine Charlotte North Carolina
United States Northwestern University Chicago Illinois
United States University of Chicago Chicago Illinois
United States Mary Crowley Medical Research Center Dallas Texas
United States Henry Ford Hospital Detroit Michigan
United States City of Hope Duarte California
United States Lacks Cancer Center at St. Mary's Health Care Grand Rapids Michigan
United States Cedars-Sinai Medical Center Los Angeles California
United States Columbia University Medical Center New York New York
United States Florida Hospital Cancer Institute Orlando Florida
United States Huntsman Cancer Institute Salt Lake City Utah
United States University of Washington Seattle Washington
United States St. Louis Hospital St. Louis Missouri
United States Washington University Medical Center St. Louis Missouri
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
TransMolecular

Country where clinical trial is conducted

United States, 

References & Publications (4)

Hockaday DC, Shen S, Fiveash J, Raubitschek A, Colcher D, Liu A, Alvarez V, Mamelak AN. Imaging glioma extent with 131I-TM-601. J Nucl Med. 2005 Apr;46(4):580-6. — View Citation

Lyons SA, O'Neal J, Sontheimer H. Chlorotoxin, a scorpion-derived peptide, specifically binds to gliomas and tumors of neuroectodermal origin. Glia. 2002 Aug;39(2):162-73. — View Citation

Mamelak AN, Jacoby DB. Targeted delivery of antitumoral therapy to glioma and other malignancies with synthetic chlorotoxin (TM-601). Expert Opin Drug Deliv. 2007 Mar;4(2):175-86. Review. — View Citation

Mamelak AN, Rosenfeld S, Bucholz R, Raubitschek A, Nabors LB, Fiveash JB, Shen S, Khazaeli MB, Colcher D, Liu A, Osman M, Guthrie B, Schade-Bijur S, Hablitz DM, Alvarez VL, Gonda MA. Phase I single-dose study of intracavitary-administered iodine-131-TM-60 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Determine Maximum Tolerated Dose (MTD) of 131-I-TM-601 administered intracavitary to patients with recurrent high-grade glioma 28 days post last dose Yes
Primary Determine the toxicity of a three (3) and six (6) dose cycle of 131-I-TM-601 administrations into the tumor resection site of patients with recurrent high-grade glioma 28 days post last dose and then at 3 month intervals from first dose, until disease progression Yes
Primary Evaluate the 6 and 12-month rate of progression and survival of patients with recurrent high-grade glioma treated with a three (3) or six (6) dose cycle of 131-I-TM-601 at 3 month intervals from first dose administration, until disease progression No
Primary Evaluate the overall time to progression and death of patients with recurrent high-grade glioma treated with either a three (3) or six (6) dose cycle of 131-I-TM-601 at 3 month intervals until disease progression No
Secondary Evaluate if either a three (3) or six (6) dose cycle of 131-I-TM-601 affects Quality of Life 3 month intervals until disease progression No
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