Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| DUMC-0334-99-2R6 | |||
| DUMC-219-96-2R3 | |||
| DUMC-302-97-2R4 | |||
| DUMC-308-98-2R5 | |||
| NCI-V96-1071 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| monoclonal antibody Me1-14 F(ab')2 | Biological |
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Darell D. Bigner, MD, PhD | Duke Cancer Institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | United States |
Not provided
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D008545 | Melanoma |
| D009362 | Neoplasm Metastasis |
| D001932 | Brain Neoplasms |
| D005909 | Glioblastoma |
| D001254 | Astrocytoma |
| D009837 | Oligodendroglioma |
| D005910 | Glioma |
| D018316 | Gliosarcoma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D018358 |
| Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D018302 | Neoplasms, Neuroepithelial |
| D009375 | Neoplasms, Glandular and Epithelial |