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Malignant GliomaPhase 2NCT00114309

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

A Phase 2 study testing 131-I-TM-601 and 131I-TM601 in people with Malignant Glioma and Glioblastoma Multiforme, run by TransMolecular at 19 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Glioma, Glioblastoma Multiforme, GBM
What is being tested?
131-I-TM-601 and 131I-TM601
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
19 sitesUnited States
Study dates
Nov 2004to Aug 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

United States19 sites

  • Emory University

    Atlanta, Georgia, 30322

  • Johns Hopkins Medical Center

    Baltimore, Maryland, 21287

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294-3410

  • Tufts-New England Medical Center

    Boston, Massachusetts, 02111

  • Carolina Neurosurgery and Spine

    Charlotte, North Carolina, 28204

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Chicago

    Chicago, Illinois, 60637

  • Mary Crowley Medical Research Center

    Dallas, Texas, 75246

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • City of Hope

    Duarte, California, 91010

  • Lacks Cancer Center at St. Mary's Health Care

    Grand Rapids, Michigan, 49503

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Columbia University Medical Center

    New York, New York, 10032

  • Florida Hospital Cancer Institute

    Orlando, Florida, 32804

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • University of Washington

    Seattle, Washington, 98195-6470

  • St. Louis Hospital

    St Louis, Missouri, 63110

  • Washington University Medical Center

    St Louis, Missouri, 63110

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
131-I-TM-601, 131I-TM601
Keywords
High grade recurrent glioma, Phase II, Multi-Center, Open label, Multiple dose, Brain Cancer, Brain Tumor, GBM, glioma
Medical subject headings
Glioma, Glioblastoma, Astrocytoma, Gliosarcoma, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 131-I-TM-601Drug

    Also called chlorotoxin

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

  • 131I-TM601Drug

    Also called chlorotoxin

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

Study groups in NCT00114309
Study groupRoleWhat they receive
1Experimental3 Dose Regimen
Receives: Drug: 131-I-TM-601
2Experimental6 Dose Regimen
Receives: Drug: 131I-TM601

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 28 days post last dose

  2. 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

    Measured: 28 days post last dose and then at 3 month intervals from first dose, until disease progression

  3. 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

    Measured: at 3 month intervals from first dose administration, until disease progression

  4. 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

    Measured: at 3 month intervals until disease progression

Secondary outcomes (1)

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

    Measured: 3 month intervals until disease progression

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2005 (estimated)
  2. Study startNov 2004
  3. Primary completionMar 2009
  4. Study completionAug 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00114309
Sponsor's protocol ID
TM-601-002
Status last verified
Apr 2009
First submitted
13 Jun 2005
Last updated
3 Apr 2009
Results posted
No

Publications

  • 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.

    PubMed 17335414

  • 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.

    PubMed 12112367

  • 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.

    PubMed 16877732

  • 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.

    PubMed 15809479

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 131-I-TM-601 and 131I-TM601 in people with Malignant Glioma and Glioblastoma Multiforme, run by TransMolecular at 19 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00114309, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2009.

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