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PROTOCOL FOR A PHASE I STUDY OF INTRATHECAL MONOCLONAL ANTIBODY FRAGMENT 131I Me1-14 F(ab')2 IN PATIENTS WITH NEOPLASMS METASTATIC TO THE LEPTOMENINGES


Phase 1/Phase 2
3 Years
N/A
Not Enrolling
Both
Metastatic Cancer

Thank you

Trial Information

PROTOCOL FOR A PHASE I STUDY OF INTRATHECAL MONOCLONAL ANTIBODY FRAGMENT 131I Me1-14 F(ab')2 IN PATIENTS WITH NEOPLASMS METASTATIC TO THE LEPTOMENINGES


OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of 131-iodine-labeled
monoclonal antibody fragment Me1-14 F(ab')2 administered intrathecally in patients with
neoplasms metastatic to the leptomeninges. II. Identify objective therapeutic responses to
this treatment.

OUTLINE: Radioimmunotherapy. Iodine-131-Labeled Monoclonal Antibody Fragment Me1-14 F(ab')2,
131I-Me1-14 F(ab')2.

PROJECTED ACCRUAL: Three to 6 patients will be treated at each dose studied.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed neoplasm that is recurrent in the
subarachnoid space Biopsy of recurrent lesion required if original diagnosis made more
than 2 years prior to entry and CSF cytology negative Radiographic evidence of measurable
lesion in the leptomeninges (by myelography, CT, or MRI) or cytologic evidence of
malignancy in the CSF Any type of neoplasm eligible provided tumor cells (tissue or CSF
preparation) bind significantly to intact monoclonal antibody Me1-14 IgG2a or to Me1-14
F(ab')2 Patency of subarachnoid pathways demonstrated by isotopic intraventricular flow

PATIENT CHARACTERISTICS: Age: 3 and over Performance status: Karnofsky 50-100%
Hematopoietic: Absolute neutrophil count at least 1,000/mm3 Platelet count at least
100,000/mm3 Hepatic: AST less than 1.5 times upper limit of normal (ULN) Alkaline
phosphatase less than 1.5 times ULN Renal: Creatinine less than 1.2 mg/dL Other: No
allergy to iodine Not pregnant or nursing

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior antineoplastic chemotherapy unless unequivocal evidence of tumor progression
No concurrent systemic chemotherapy Endocrine therapy: Corticosteroids allowed if at
lowest possible dose and stable for at least 10 days prior to entry Radiotherapy: At least
3 months since prior radiotherapy to site of measurable disease unless unequivocal
evidence of disease progression Surgery: Not specified

Type of Study:

Interventional

Study Design:

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:

1193

NCT ID:

NCT00002751

Start Date:

July 1989

Completion Date:

May 2004

Related Keywords:

  • Metastatic Cancer
  • leptomeningeal metastases
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Duke Comprehensive Cancer CenterDurham, North Carolina  27710