Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

Iodine I 131 Monoclonal Antibody TNT-1/B in Treating Patients With Progressive or Recurrent Glioblastoma Multiforme

Lead Sponsor:

Abramson Cancer Center at Penn Medicine

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Brain and Central Nervous System Tumors

Eligibility:

All Genders

18-120 years

Phase:

PHASE1

Brief Summary

RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody TNT-1/B (\^131I MOAB TNT-1/B), can find tumor cells and carry tumor-killing substances to them without harming n...

Detailed Description

OBJECTIVES: Primary * Determine the maximum tolerated dose of iodine I 131 monoclonal antibody TNT-1/B in patients with progressive or recurrent glioblastoma multiforme. Secondary * Determine the ...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically confirmed glioblastoma multiforme
  • Focal disease
  • Progressive or recurrent disease after prior treatment with radiotherapy and/or chemotherapy
  • Low-grade astrocytoma that progressed to glioblastoma multiforme after prior radiotherapy and/or chemotherapy allowed
  • Gross tumor volume 5-60 mL
  • No intraventricular tumor, infratentorial tumor, or tumor that communicates with the ventricles
  • No bilateral non-contiguous gadolinium-enhancing tumor
  • No diffuse disease, defined as any satellite lesion \> 1.5 cm from the anticipated location of a catheter tip OR \> 2 satellite lesions
  • No ventricular invasion outside the anticipated radiotherapy volume
  • PATIENT CHARACTERISTICS:
  • Age
  • 18 and over
  • Performance status
  • Karnofsky 60-100%
  • Life expectancy
  • Not specified
  • Hematopoietic
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • Platelet count ≥ 100,000/mm\^3
  • Hemoglobin ≥ 9.0 g/dL
  • Hepatic
  • Bilirubin ≤ 1.5 mg/dL
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Hepatitis B negative
  • No evidence of active hepatitis
  • Renal
  • Creatinine ≤ 1.7 mg/dL
  • BUN ≤ 2 times ULN
  • Cardiovascular
  • No uncontrolled hypertension
  • No unstable angina pectoris
  • No uncontrolled cardiac dysrhythmia
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Able to undergo MRI
  • Mini Mental State Exam score ≥ 15
  • No serious infection
  • No other medical illness that would preclude study participation
  • No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
  • No psychological or sociological condition, addictive disorder, or other condition that would preclude study compliance
  • No known or suspected allergy to study drug or iodine
  • No known HIV positivity
  • PRIOR CONCURRENT THERAPY:
  • Biologic therapy
  • No prior monoclonal antibodies
  • No prior local immunotherapy or treatment with the following biologic agents:
  • Immunotoxins
  • Immunoconjugates
  • Antiangiogenesis compounds
  • Antisense agents
  • Peptide receptor antagonist
  • Interferons
  • Interleukins
  • Tumor infiltrating lymphocytes
  • Lymphokine-activated killer cells
  • Gene therapy
  • Chemotherapy
  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • At least 3 months since prior polifeprosan 20 with carmustine implant (Gliadel wafer\^® )
  • Endocrine therapy
  • Must be maintained on a stable corticosteroid dose (approximately 4 mg) for ≥ 2 weeks before study entry
  • Radiotherapy
  • See Disease Characteristics
  • At least 3 months since prior radiotherapy
  • No prior brachytherapy or radiosurgery
  • Surgery
  • At least 4 weeks since prior surgery
  • Other
  • Recovered from all prior therapy
  • At least 1 month since prior investigational agents
  • No more than 2 prior treatment regimens
  • No other prior local therapy

Exclusion

    Key Trial Info

    Start Date :

    October 1 2005

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    October 1 2007

    Estimated Enrollment :

    22 Patients enrolled

    Trial Details

    Trial ID

    NCT00128635

    Start Date

    October 1 2005

    End Date

    October 1 2007

    Last Update

    February 19 2016

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham

    Birmingham, Alabama, United States, 35294

    2

    Winship Cancer Institute of Emory University

    Atlanta, Georgia, United States, 30322

    3

    Wake Forest University Comprehensive Cancer Center

    Winston-Salem, North Carolina, United States, 27157-1096

    4

    Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, United States, 19104-4283