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Monoclonal Antibody Therapy in Treating Patients With Primary or Metastatic Melanoma or Brain Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002754
Recruitment Status : Completed
First Posted : July 29, 2004
Last Update Posted : February 20, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Duke University

Brief Summary:

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/II trial to determine the effectiveness of monoclonal antibody therapy in treating patients who have primary or metastatic melanoma or brain tumors.

Condition or disease Intervention/treatment Phase
Brain and Central Nervous System Tumors Melanoma (Skin) Metastatic Cancer Biological: monoclonal antibody Me1-14 F(ab')2 Phase 1

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Primary Purpose: Treatment
Study Start Date : February 1993
Actual Primary Completion Date : April 2001
Actual Study Completion Date : April 2001

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002754

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United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
National Cancer Institute (NCI)
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Study Chair: Darell D. Bigner, MD, PhD Duke Cancer Institute
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Responsible Party: Duke University Identifier: NCT00002754    
Other Study ID Numbers: CDR0000064690
First Posted: July 29, 2004    Key Record Dates
Last Update Posted: February 20, 2013
Last Verified: February 2013
Keywords provided by Duke University:
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
Additional relevant MeSH terms:
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Brain Neoplasms
Nervous System Neoplasms
Central Nervous System Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs