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Phase I Study of Anti-Tenascin Monoclonal Antibody I-Labeled 81C6 Via Surgically Created Cystic Resection Cavity in the Treatment of Patients With Primary Brain Tumors After External Beam Radiotherapy


Phase 1
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Neuroblastoma

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Trial Information

Phase I Study of Anti-Tenascin Monoclonal Antibody I-Labeled 81C6 Via Surgically Created Cystic Resection Cavity in the Treatment of Patients With Primary Brain Tumors After External Beam Radiotherapy


OBJECTIVES:

- Determine the toxicity of iodine I 131 monoclonal antibody 81C6 delivered via the
intracranial resection cavity in patients with newly diagnosed primary malignant brain
tumors after surgery and radiotherapy.

- Determine objective therapeutic responses of these patients to this treatment.

OUTLINE: This is a dose escalation study of iodine I 131 antitenascin monoclonal antibody
81C6 (I 131 MAb 81C6).

Within 2-4 weeks after completion of external beam radiotherapy, patients undergo surgical
resection of the tumor or brain metastasis, at which time an indwelling intracranial
resection cavity catheter is placed. A single dose of I 131 MAb 81C6 is delivered via the
intralesional catheter.

Cohorts of 3-6 patients receive escalating doses of I 131 MAb 81C6 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 6 patients experience dose limiting toxicities.

After the MTD has been established, patients in the phase II portion of the study receive
therapy as in phase I.

Beginning 4 weeks after the monoclonal antibody treatment, patients begin chemotherapy.
Patients receive carmustine IV over 1 hour on day 1 and irinotecan IV over 90 minutes once
weekly for 4 weeks. Treatment is repeated every 6 weeks for at least 4 courses in the
absence of disease progression.

Patients are followed initially at 4 weeks, then every 6 weeks for 1 year.

PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed newly diagnosed supratentorial primary malignant brain tumor

- No infratentorial tumors, infiltrating tumors, tumors with subependymal spread, or
multifocal tumors

- Candidate for surgical resection

- Prior external beam radiotherapy to site of measurable disease or resection site in
the nervous system required

- Presence of tenascin in the tumor demonstrated by immunohistology with either a
polyclonal rabbit antitenascin antibody or monoclonal antibody 81C6

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 50-100%

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count greater than 1000/mm^3

- Platelet count greater than 100,000/mm^3

Hepatic:

- Bilirubin less than 1.5 mg/dL

- Alkaline phosphatase less than 1.5 times normal

- Lactic dehydrogenase less than 1.5 times normal

- SGOT less than 1.5 times normal

Renal:

- Creatinine less than 1.2 mg/dL

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No iodine allergies

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Concurrent corticosteroids allowed, but must be on stable dose for at least 10 days

Radiotherapy:

- See Disease Characteristics

Surgery:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Darell D. Bigner, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke University

Authority:

United States: Federal Government

Study ID:

Pro00008915

NCT ID:

NCT00003484

Start Date:

September 1997

Completion Date:

March 2010

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Neuroblastoma
  • localized resectable neuroblastoma
  • recurrent adult brain tumor
  • adult craniopharyngioma
  • adult medulloblastoma
  • adult meningioma
  • adult glioblastoma
  • adult oligodendroglioma
  • adult anaplastic astrocytoma
  • adult mixed glioma
  • adult pineal parenchymal tumor
  • adult central nervous system germ cell tumor
  • adult grade III meningioma
  • adult pilocytic astrocytoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Neuroblastoma
  • Central Nervous System Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710