Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer (NCT00003022) | Clinical Trial Compass
CompletedPhase 1
Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer
United StatesStarted 1997-04
Plain-language 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 trial to study the effectiveness of monoclonal antibody therapy in treating patients who have leptomeningeal metastases.
Who can participate
Age range3 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed malignancy expressing GD2, including, but not limited to:
* Medulloblastoma/primitive neuroectodermal tumor of the CNS
* Malignant glioma
* Neuroblastoma
* Retinoblastoma
* Ependymoma
* Sarcoma
* Melanoma
* Small cell lung carcinoma
* Other tumor types must have GD2 expression confirmed by immunohistochemical staining
* Cerebrospinal fluid or leptomeningeal disease that is refractory to conventional therapy or for which no conventional therapy exists
* Prior measurable human anti-mouse monoclonal antibody titer allowed
PATIENT CHARACTERISTICS:
Age:
* 3 and over
Performance status:
* Not specified
Life expectancy:
* At least 2 months
Hematopoietic:
* Absolute neutrophil count greater than 1,000/mm\^3
* Platelet count greater than 50,000/mm\^3
Hepatic:
* Bilirubin less than 3 mg/dL
Renal:
* Creatinine less than 2 mg/dL
* Blood urea nitrogen less than 30 mg/dL
Other:
* May have active malignancy outside the central nervous system
* No obstructive hydrocephalus
* No CNS grade 3 or 4 toxicity as a consequence of prior treatments
* No life threatening infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Prior monoclonal antibody treatment allowed
Chemotherapy:
* Prior chemotherapy allowed
* Must have recovered from all hematopoietic and neurologic side effects of prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* Prior radiotherapy allowed
* At least 6 weeks since p…