RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Phase I trial to determine the effectiveness of monoclonal antibody therapy in patients with primary or metastatic brain cancer.

Condition	Treatment or Intervention	Phase
Astrocytoma Brain Tumor Oligodendroglioma Glioblastoma Multiforme Glioma	Drug: monoclonal antibody Me1-14 F(ab')2	Phase I

Further Study Details: 

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 brain tumors.

II. Identify any objective therapeutic responses to this treatment.

PROTOCOL 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.

Ages Eligible for Study:  3 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• 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

--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

--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; LDH less than 1.5 times normal
• Renal: Creatinine less than 1.2 mg/dL
• Other: No pregnant women

North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States

Study chairs or principal investigators

Ilkcan Cokgor,  Study Chair,  Duke Comprehensive Cancer Center   

Study ID Numbers:  CDR0000064690; DUMC-0334-99-2R6; NCI-V96-1071; DUMC-219-96-2R3; DUMC-302-97-2R4; DUMC-308-98-2R5
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002754
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08