131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma

NCT ID: NCT00114309

Last Updated: 2009-04-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2009-08-31

Brief 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.

Detailed 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.

Conditions

Malignant Glioma; Glioblastoma Multiforme; GBM; Anaplastic Astrocytoma; Oligo-Astrocytoma; Gliosarcoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

3 Dose Regimen

Group Type: EXPERIMENTAL

131-I-TM-601

Intervention Type: DRUG

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

2

6 Dose Regimen

Group Type: EXPERIMENTAL

131I-TM601

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

131I-TM601

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

Intervention Type: DRUG

Other Intervention Names

chlorotoxin; chlorotoxin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TransMolecular

INDUSTRY

Sponsor Role: lead

Responsible Party

TransMolecular, Inc.

Principal Investigators

John Fiveash, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

City of Hope

Duarte, California, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Florida Hospital Cancer Institute

Orlando, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Johns Hopkins Medical Center

Baltimore, Maryland, United States

Tufts-New England Medical Center

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Lacks Cancer Center at St. Mary's Health Care

Grand Rapids, Michigan, United States

St. Louis Hospital

St Louis, Missouri, United States

Washington University Medical Center

St Louis, Missouri, United States

Columbia University Medical Center

New York, New York, United States

Carolina Neurosurgery and Spine

Charlotte, North Carolina, United States

Mary Crowley Medical Research Center

Dallas, Texas, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

University of Washington

Seattle, Washington, United States

Countries

United States

References

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. doi: 10.1517/17425247.4.2.175.

Reference Type: BACKGROUND

PMID: 17335414 (View on PubMed)

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. doi: 10.1002/glia.10083.

Reference Type: BACKGROUND

PMID: 12112367 (View on PubMed)

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-601 in adults with recurrent high-grade glioma. J Clin Oncol. 2006 Aug 1;24(22):3644-50. doi: 10.1200/JCO.2005.05.4569.

Reference Type: RESULT

PMID: 16877732 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15809479 (View on PubMed)

Other Identifiers

TM-601-002

Identifier Type: -

Identifier Source: org_study_id