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A Phase 1/2 Multi-Center, Safety and Efficacy Study Evaluating Intravenously Administered 131I-TM601 in Patients With Progressive and/or Recurrent Malignant Glioma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Malignant Glioma, Glioblastoma Multiforme, GBM, Astrocytoma, Oligodendroglioma

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Trial Information

A Phase 1/2 Multi-Center, Safety and Efficacy Study Evaluating Intravenously Administered 131I-TM601 in Patients With Progressive and/or Recurrent Malignant Glioma

This is a multi-center, open label, non-randomized, Phase 1/2 study evaluating the use of
multiple intravenous doses of 131I-TM601 in patients with progressive and/or recurrent
malignant glioma.

The study will be conducted in two phases. Prior to initiating treatment as part of this
study, patients will be administered a single imaging dose of 131I-TM601, IV, to demonstrate
tumor uptake. Only patients demonstrating tumor uptake will remain on the study. During
the first, Dose Escalation Phase of the study, eligible patients will be assigned in groups
of 3-6 (depending upon the treatment response seen at each dose) to dose cohorts of between
2-5 weekly IV doses of 131I-TM601, with escalation to the next highest dose dependent upon
demonstrated tolerance in the previous dosing group. Patients enrolled in the second phase
will be assigned to a dose determined by the experience in the first phase.

Patients in both study phases will have safety parameters evaluated continuously throughout
the study. Clinical response to 131I-TM601 will be assessed in each study patient at 28
days following the final study dose, and then at quarterly intervals scheduled at 3 month
intervals following the first study dose, until disease progression.

Inclusion Criteria:

Patients must:

1. Have histologically proven malignant glioma (anaplastic astrocytoma, anaplastic
oligodendroglioma or glioblastoma multiforme) which is progressive and/or recurrent
after external beam radiation therapy (to at least 50 Gy) ± chemotherapy with or
without a history of surgical resection. Patients with previous low grade glioma who
progressed after radiotherapy ± chemotherapy and are biopsied and found to have a
high grade glioma are eligible. Patients with prior therapy that included
interstitial brachytherapy, stereotactic radiosurgery, or local radiopharmaceutical
injection must have confirmation of true progressive disease rather than radiation
necrosis based upon PET or Thallium scanning or pathological documentation of

2. Have bi-dimensional measurable disease, defined as ≥ 1 lesion that can be accurately
measured in ≥ 2 planes on post-contrast MRI.

Note - a CT scan will be acceptable in place of an MRI only in patients who are
unable to undergo an MRI.

3. Be ≥18 years of age.

4. Have a baseline Karnofsky Performance Status (KPS) of ≥60%.

5. Have a Mini Mental State Exam score of ≥ 19.

6. Have a life expectancy, based on the Investigator's judgment, of >3 months.

7. On screening ECG, have a QTc interval of <450 ms.

8. If taking steroids, be on a dose that is stable for at least 5 days prior to the
Imaging Dose.

9. 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.

10. Have adequate organ and marrow function as defined by serum chemistry evaluations
(defined in study protocol).

11. Have a negative serum pregnancy test within 14 days of study drug administration, if
female and of child bearing potential.

12. Agree to use an effective form of contraception to avoid pregnancy, if fertile
(applicable to both male and female patients).

13. Agree to refrain from nursing, if female.

14. Have signed and dated written informed consent.

15. Be able to comply with treatment plan, study procedures and follow-up examinations.

Exclusion Criteria:

Patients may not:

1. 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 include, but are 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.

2. 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.

3. Have received radiation treatments ≤ 3 months prior to first study drug
administration (Imaging Dose).

4. Have received any cytotoxic chemotherapy, whether conventional or investigational, ≤
4 weeks prior to receiving the first study drug (Imaging Dose) administration in this
study (6 weeks for mitomycin-C or nitrosoureas).

5. Have a history of allergic reactions attributed to compounds of similar chemical or
biologic composition to 131I-TM601 e.g. iodine or iodine-containing drugs.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The safety and tolerability of multiple doses of intravenously (IV) administered 131I-TM601 in adult patients with progressive and/or recurrent malignant glioma with measurable disease.

Outcome Time Frame:

Safety will be evaluated throughout the treatment and follow-up phase for all study patients; dose escalation decisions will be based on safety experience for each patient at 21 days following the final treament dose.

Safety Issue:


Principal Investigator

Karen Fink, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Baylor Health Care System


United States: Food and Drug Administration

Study ID:




Start Date:

August 2008

Completion Date:

April 2010

Related Keywords:

  • Malignant Glioma
  • Glioblastoma Multiforme
  • GBM
  • Astrocytoma
  • Oligodendroglioma
  • High grade recurrent glioma
  • Phase 2
  • Phase 1
  • Multi-center
  • Open label
  • Multiple dose
  • Brain Cancer
  • Brain Tumor
  • GBM
  • glioma
  • glioblastoma
  • astrocytoma
  • oligodendroglioma
  • 131I-TM601
  • TM601
  • Astrocytoma
  • Glioblastoma
  • Glioma
  • Oligodendroglioma



Johns Hopkins University Baltimore, Maryland  21205
University of Virginia Charlottesville, Virginia  22908
University of Chicago Chicago, Illinois  60637
St. Mary's Health Care Grand Rapids, Michigan  49503