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Phase I Study of Intra-Tumoral, Radiolabeled, Anti-Tenascin Monoclonal Antibody 81C6 in the Treatment of Patients With Malignant Primary Brain Tumors


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

Phase I Study of Intra-Tumoral, Radiolabeled, Anti-Tenascin Monoclonal Antibody 81C6 in the Treatment of Patients With Malignant Primary Brain Tumors


OBJECTIVES:

- Determine which one of two delivery techniques (bolus injection versus microinfusion)
provides the greater distribution volume of iodine I 131 antitenascin monoclonal
antibody 81C6 (I 131 MAb 81C6) administered intratumorally in patients with newly
diagnosed or recurrent malignant primary brain tumors.

- Determine the maximum tolerated dose of I 131 MAb 81C6 delivered intratumorally in
these patients.

- Evaluate the efficacy of I 131 MAB 81C6 delivered intratumorally in these patients.

OUTLINE: This is a randomized, dose-escalation study.

Patients are randomized to receive iodine I 131 antitenascin monoclonal antibody 81C6 (I 131
MAb 81C6) by one of two delivery techniques first, then crossover to receive the antibody by
the other technique 3 days later. Each patient then receives a therapeutic dose by the most
efficient method. Both methods are delivered via a stereotactically-placed intralesional
catheter.

- Arm I: Bolus injection method

- Arm II: Microinfusion delivery method Cohorts of 3-6 patients receive escalating doses
of I 131 MAb 81C6, with dose escalation occurring separately for each arm. After 10
patients are enrolled and the best method of administration is determined, all
subsequent patients receive I 131 MAb 81C6 by that method, and the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which no more the 2 of 6
patients experience dose-limiting toxicity.

Patients with newly diagnosed tumors for which no effective conventional therapy exists,
such as malignant glial tumors, are treated with external beam radiotherapy within 4 months
after I 131 MAb 81C6 infusion. Patients with recurrent tumors receive no other therapy
unless tumor progresses.

Patients are followed at 4, 8, 16, and 24 weeks and then every 12 weeks for one year.

PROJECTED ACCRUAL: At least 10 patients will be accrued for this study within 1 year.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically proven newly diagnosed or recurrent primary intracranial WHO grade III
or IV glioma

- Reactivity of tumor cells with 81C6 demonstrated by immunohistology with either a
polyclonal rabbit antibody or the monoclonal mouse antibody

- Radiographic evidence of a single lesion by MRI or CT scan

- No greater than 2 to 5 cm

- No cerebral herniation syndrome

- Midline brain shift less than 0.5 cm

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Karnofsky 60-100%

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count greater than 1000/mm^3

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

- Hemoglobin greater than 10 g/dL

Hepatic:

- Bilirubin less than 1.5 mg/dL

- Alkaline phosphatase less than 1.5 times normal

- SGOT less than 1.5 times normal

Renal:

- Creatinine less than 2.0 mg/dL

Other:

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No allergies to iodine or local anesthetics

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent autologous bone marrow transplant

Chemotherapy:

- No more than 1 prior conventional or phase II chemotherapy regimen

- No prior phase I chemotherapy regimens

- At least 4 weeks since prior chemotherapy

- No concurrent systemic chemotherapy

Endocrine therapy:

- Corticosteroids allowed but must be on stable dose for at least 1 week

Radiotherapy:

- At least 3 months since radiotherapy to site of measurable disease in the nervous
system, unless evidence of progression

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Darell D. Bigner, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

1529

NCT ID:

NCT00003478

Start Date:

October 1997

Completion Date:

July 2007

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult brain stem glioma
  • adult medulloblastoma
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult anaplastic ependymoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • adult ependymoblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Brain Neoplasms
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710