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

Primary Purpose

Malignant Glioma, Glioblastoma Multiforme, GBM

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
131-I-TM-601
131I-TM601
Sponsored by
TransMolecular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Glioma focused on measuring High grade recurrent glioma, Phase II, Multi-Center, Open label, Multiple dose, Brain Cancer, Brain Tumor, GBM, glioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • City of Hope
  • Cedars-Sinai Medical Center
  • Florida Hospital Cancer Institute
  • Moffitt Cancer Center
  • Emory University
  • Northwestern University
  • University of Chicago
  • Johns Hopkins Medical Center
  • Tufts-New England Medical Center
  • Henry Ford Hospital
  • Lacks Cancer Center at St. Mary's Health Care
  • St. Louis Hospital
  • Washington University Medical Center
  • Columbia University Medical Center
  • Carolina Neurosurgery and Spine
  • Mary Crowley Medical Research Center
  • Huntsman Cancer Institute
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

3 Dose Regimen

6 Dose Regimen

Outcomes

Primary Outcome Measures

Determine Maximum Tolerated Dose (MTD) of 131-I-TM-601 administered intracavitary to patients with recurrent high-grade glioma
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
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
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

Secondary Outcome Measures

Evaluate if either a three (3) or six (6) dose cycle of 131-I-TM-601 affects Quality of Life

Full Information

First Posted
June 13, 2005
Last Updated
April 1, 2009
Sponsor
TransMolecular
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1. Study Identification

Unique Protocol Identification Number
NCT00114309
Brief Title
131-I-TM-601 Study in Adults With Recurrent High-Grade Glioma
Official Title
A Phase II Open-Label, Multiple-Dose Study of Intracavitary Administered 131-I-TM-601 in Adult Patients With Recurrent High-Grade Glioma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2004 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
August 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
TransMolecular

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Glioma, Glioblastoma Multiforme, GBM, Anaplastic Astrocytoma, Oligo-Astrocytoma, Gliosarcoma
Keywords
High grade recurrent glioma, Phase II, Multi-Center, Open label, Multiple dose, Brain Cancer, Brain Tumor, GBM, glioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
3 Dose Regimen
Arm Title
2
Arm Type
Experimental
Arm Description
6 Dose Regimen
Intervention Type
Drug
Intervention Name(s)
131-I-TM-601
Other Intervention Name(s)
chlorotoxin
Intervention Description
131I-TM601, in solution, delivered intracavitarily following surgical resection 3 weekly administrations, 0.8 mg TM601 and 40mCi 131Iodine, per dose.
Intervention Type
Drug
Intervention Name(s)
131I-TM601
Other Intervention Name(s)
chlorotoxin
Intervention Description
131I-TM601, in solution, delivered intracavitarily following surgical resection 6 weekly administrations, 0.8 mg TM601 and 40mCi 131Iodine, per dose.
Primary Outcome Measure Information:
Title
Determine Maximum Tolerated Dose (MTD) of 131-I-TM-601 administered intracavitary to patients with recurrent high-grade glioma
Time Frame
28 days post last dose
Title
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
Time Frame
28 days post last dose and then at 3 month intervals from first dose, until disease progression
Title
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
Time Frame
at 3 month intervals from first dose administration, until disease progression
Title
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
Time Frame
at 3 month intervals until disease progression
Secondary Outcome Measure Information:
Title
Evaluate if either a three (3) or six (6) dose cycle of 131-I-TM-601 affects Quality of Life
Time Frame
3 month intervals until disease progression

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Fiveash, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3410
Country
United States
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Florida Hospital Cancer Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Johns Hopkins Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Tufts-New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Lacks Cancer Center at St. Mary's Health Care
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
St. Louis Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University Medical Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Carolina Neurosurgery and Spine
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Mary Crowley Medical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Huntsman Cancer Institute
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195-6470
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17335414
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. doi: 10.1517/17425247.4.2.175.
Results Reference
background
PubMed Identifier
12112367
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. doi: 10.1002/glia.10083.
Results Reference
background
PubMed Identifier
16877732
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-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.
Results Reference
result
PubMed Identifier
15809479
Citation
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.
Results Reference
result

Learn more about this trial

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

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