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

NCT00128635 | Completed Phase 1

• 2 other identifiers: CDR0000438768NABTT-0404
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Brain and Central Nervous System Tumors

Keywords

adult glioblastoma; adult gliosarcoma; adult giant cell glioblastoma; recurrent adult brain tumor

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose based on CTCAE v3.0 weekly for 8 weeks then every 8 weeks

Secondary Outcomes (3)

• Biodistribution and radiation dosimetry by blood, urine, and whole body scans daily for 10 days

• Toxicity by CTCAE v3.0 weekly for 12 weeks then every 8 weeks

• Overall survival, median time of survival, and percent alive at 6 months

Interventions

iodine I 131 monoclonal antibody TNT-1/B RADIATION

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham

Birmingham, Alabama, 35294, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Wake Forest University Comprehensive Cancer Center

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

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Glioblastoma; Gliosarcoma; Brain Neoplasms

Interventions

131I-chimeric TNT-1-B monoclonal antibody

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Diseases; Central Nervous System Diseases

Study Officials

• Robert A. Lustig, MD

  Abramson Cancer Center at Penn Medicine

  STUDY CHAIR

• Kevin Judy, MD

  Abramson Cancer Center at Penn Medicine

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 8, 2005
• First Posted: August 10, 2005
• Study Start: October 1, 2005
• Study Completion: October 1, 2007
• Last Updated: February 19, 2016

Record last verified: 2007-05

Locations

US (4)