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A Phase 2a, Multi-Center, Open-Label Study of I-131-CLR1404 in Subjects With Recurrent Glioma


Phase 2
18 Years
N/A
Not Enrolling
Both
Glioma

Thank you

Trial Information

A Phase 2a, Multi-Center, Open-Label Study of I-131-CLR1404 in Subjects With Recurrent Glioma


Inclusion Criteria:



- Histologically confirmed high-grade glioblastoma multiforme (GBM)

- Failed prior therapy with Avastin

- Radiologic evidence of tumor progression

- Received at least 45 Gy and no more than 66 Gy prior radiotherapy

- Ambulatory with an ECOG performance status of 0 to 2 (Appendix C)

- 18 years of age or older

Exclusion Criteria:

- Received more than 25% of total bone marrow irradiated, total body or hemi-body
irradiation or prior radioisotope therapy (except for benign thyroid disease)

- Prior radiation therapy or chemotherapy within 4 weeks of start of study

- Another active medical condition(s) or organ disease(s) that may compromise subject
safety or interfere with safety and/or outcome evaluation of study drug

- Laboratory abnormalities, including but not limited to: WBC < 3000/uL, Absolute
neutrophil count < 1500/uL, Platelets < 150,000/uL, Hemoglobin ≤ 9.0 gm/dL, Total
bilirubin > 1.5 x upper limit of normal for age, SGOT or SGPT > 3 x upper limit of
normal for age if no liver metastases or > 5 x upper limit of normal for age in the
presence of liver metastases, Serum creatinine > 1.5 x upper limit of normal for age,
2+ proteinuria or casts indicative of intrinsic renal disease

- Treatment with investigational drug, investigational biologic, or investigational
therapeutic device within 28 days of initiating study treatment

- Received prior stem cell transplantation

- Clinically significant cardiac co-morbidities including congestive heart failure (New
York Heart Association class III-IV heart disease), left ventricular ejection
fraction < 40%, unstable angina pectoris, serious cardiac arrhythmia requiring
medication or pacemaker, myocardial infarction within past 6 months

- Concurrent or recent (within 1 month) use of thrombolytic agents, or full-dose
anticoagulants (except to maintain patency of preexisting, permanent indwelling IV
catheters).

- Uncontrolled hypertension as defined by systolic blood pressure > 150 mm/Hg,
diastolic blood pressure > 100 mm/Hg or uncontrolled diabetes that would compromise
subject safety or interfere with safety and/or outcome evaluation of study drug

- Major surgery within 4 weeks of enrollment

- Poor venous access and unable to receive study drug into a peripheral venous catheter

- Significant traumatic injury within past 4 weeks

- Ongoing or active infection requiring antibiotics or with fever >38.1º C (>101º F)
within 3 days of first scheduled day of dosing

- Receiving concurrent hemodialysis or peritoneal dialysis

- Known positive for HIV, Hepatitis C (active, previously treated or both), or is
Hepatitis B core antigen positive

- Pregnant or lactating

- Hospitalized

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Evaluate the 6-month survival rate of subjects receiving I-131-CLR1404 for relapsed glioma

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Minesh Mehta, M.D., FASTRO

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Marylannd School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

DCL-13-001

NCT ID:

NCT01778088

Start Date:

May 2013

Completion Date:

January 2015

Related Keywords:

  • Glioma
  • Glioma

Name

Location

University of Maryland School of Medicine Baltimore, Maryland  21201-1619