TheranosticTrials.org

Clinical Trial · NCT00128635

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

Overview

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 normal cells. This may be an effective treatment for glioblastoma multiforme. PURPOSE: This phase I trial is studying the side effects and best dose of \^131I MOAB TNT-1/B in treating patients with progressive or recurrent glioblastoma multiforme.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Phase

Phase 1

Contacts

Kevin Judy, MD

Robert A. Lustig, MD (STUDY_CHAIR)

ClinicalTrials.gov

NCT00128635

Drug / Compound

monoclonal antibody TNT-1/B

Isotope(s):
Target(s):
  • Apoptosis
Ligand Class: Antibodies

Eligibility

Inclusion

  • At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas)
  • At least 4 weeks since prior surgeryOther
  • At least 3 months since prior radiotherapy
  • Negative pregnancy test
  • Progressive or recurrent disease after prior treatment with radiotherapy and/or chemotherapy
  • Gene therapyChemotherapy
  • Creatinine ≤ 1.7 mg/dL
  • Histologically confirmed glioblastoma multiforme
  • Interferons
  • BUN ≤ 2 times ULNCardiovascular
  • Lymphokine-activated killer cells
  • Interleukins
  • Gross tumor volume 5-60 mL
  • Absolute neutrophil count ≥ 1,500/mm\^3
  • At least 1 month since prior investigational agents
  • Mini Mental State Exam score ≥ 15
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN)
  • Able to undergo MRI
  • Must be maintained on a stable corticosteroid dose (approximately 4 mg) for ≥ 2 weeks before study entryRadiotherapy
  • Hepatitis B negative
  • Hemoglobin ≥ 9.0 g/dLHepatic
  • Bilirubin ≤ 1.5 mg/dL
  • Antisense agents
  • Immunotoxins
  • Tumor infiltrating lymphocytes
  • At least 3 months since prior polifeprosan 20 with carmustine implant (Gliadel wafer\^® )Endocrine therapy
  • Fertile patients must use effective contraception
  • Peptide receptor antagonist
  • Recovered from all prior therapy
  • Antiangiogenesis compounds
  • Low-grade astrocytoma that progressed to glioblastoma multiforme after prior radiotherapy and/or chemotherapy allowed
  • 18 and overPerformance status
  • Immunoconjugates
  • Focal disease
  • Karnofsky 60-100%Life expectancy
  • Platelet count ≥ 100,000/mm\^3

Exclusion

  • No uncontrolled cardiac dysrhythmiaOther
  • No bilateral non-contiguous gadolinium-enhancing tumor
  • No serious infection
  • No uncontrolled hypertension
  • No known or suspected allergy to study drug or iodine
  • No other malignancy within the past 5 years except curatively treated carcinoma in situ or basal cell skin cancer
  • No known HIV positivityBiologic therapy
  • No intraventricular tumor, infratentorial tumor, or tumor that communicates with the ventricles
  • No other medical illness that would preclude study participation
  • Not pregnant or nursing
  • No prior monoclonal antibodies
  • No evidence of active hepatitisRenal
  • No diffuse disease, defined as any satellite lesion \> 1.5 cm from the anticipated location of a catheter tip OR \> 2 satellite lesions
  • Not specifiedHematopoietic
  • No unstable angina pectoris
  • No other prior local therapy
  • No prior local immunotherapy or treatment with the following biologic agents:
  • No prior brachytherapy or radiosurgerySurgery
  • No psychological or sociological condition, addictive disorder, or other condition that would preclude study compliance
  • No more than 2 prior treatment regimens