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PHASE I STUDY OF MONOCLONAL ANTIBODY FRAGMENT 131I MEL-14 F(AB')2 VIA SURGICALLY CREATED CYSTIC RESECTION CAVITY IN THE TREATMENT OF PATIENTS WITH PRIMARY OR METASTATIC MALIGNANT MELANOMA AND OTHER BRAIN TUMORS


Phase 1
3 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Melanoma (Skin), Metastatic Cancer

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Trial Information

PHASE I STUDY OF MONOCLONAL ANTIBODY FRAGMENT 131I MEL-14 F(AB')2 VIA SURGICALLY CREATED CYSTIC RESECTION CAVITY IN THE TREATMENT OF PATIENTS WITH PRIMARY OR METASTATIC MALIGNANT MELANOMA AND OTHER BRAIN TUMORS


OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of iodine-131-labeled
monoclonal antibody fragment ME1-14 F(ab')2 administered intracystically in patients with
recurrent or newly diagnosed primary or metastatic malignant melanoma or other brain tumors.
II. Identify any objective therapeutic responses to this treatment.

OUTLINE: All patients receive a fixed dose of monoclonal antibody fragment ME1-14 F(ab')2
via an intralesional catheter; cohorts of 3-6 patients receive escalating doses of isotope
conjugated to the antibody until the maximum tolerated dose is determined. Patients with
newly diagnosed disease at entry may receive additional therapy with external-beam
radiotherapy beginning 4 months after radioimmunotherapy (or sooner if disease progression
occurs). Patients with recurrent disease at entry are followed without further therapy for
at least 4 months after radioimmunotherapy; alternative therapy may be offered upon
progression. All patients are followed at 4, 8, 16, and 24 weeks after treatment, then every
12 weeks for 1 year.

PROJECTED ACCRUAL: Three to six patients will be entered at each dose studied.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed primary or metastatic malignant melanoma
OR Histologically confirmed supratentorial malignant brain tumor Newly diagnosed or
recurrent primary or metastatic tumor Eligible primary histologies, including but not
limited to: Glioblastoma multiforme Mixed anaplastic glioma Anaplastic astrocytoma Other
astrocytoma Gliosarcoma Anaplastic oligodendroglioma The following excluded: Diffusely
infiltrating tumors Multifocal tumors Infratentorial tumors Subependymal spread No
measurable enhancing lesion extending more than 1 cm beyond margins of surgical cavity on
contrast-enhanced CT or MRI performed within 72 hours after resection Intralesional
catheter placed at resection Patency of catheter demonstrated by radiolabeled albumin flow
Reactivity of neoplastic cells with intact Me1-14 IgG2a or Me1-14 F(ab')2 demonstrated by
immunohistology with polyclonal rabbit antibody or monoclonal mouse antibody

PATIENT CHARACTERISTICS: Age: 3 and over Performance status: Karnofsky 50%-100%
Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Platelet count greater
than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL AST less than 1.5 times normal
Alkaline phosphatase less than 1.5 times normal Renal: Creatinine less than 1.2 mg/dL
Other: Not pregnant

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks
since antineoplastic chemotherapy unless unequivocal tumor progression Endocrine therapy:
Concurrent corticosteroids allowed at lowest possible dose and stable for at least 10 days
prior to entry Radiotherapy: At least 3 months since radiotherapy to site of measurable
disease within the nervous system unless unequivocal tumor progression Surgery: See
Disease Characteristics

Type of Study:

Interventional

Study Design:

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:

CDR0000064690

NCT ID:

NCT00002754

Start Date:

February 1993

Completion Date:

April 2001

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Melanoma (Skin)
  • Metastatic Cancer
  • recurrent adult brain tumor
  • adult glioblastoma
  • stage IV melanoma
  • tumors metastatic to brain
  • childhood high-grade cerebral astrocytoma
  • adult anaplastic astrocytoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • recurrent childhood cerebral astrocytoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Brain Neoplasms
  • Melanoma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710