cropped color_logo_with_background.png

Clinical Trial Finder

Monoclonal Antibody Therapy in Treating Patients With Leptomeningeal Cancer

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 3 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 prior cranial or spinal irradiation.
Surgery: - Not specified

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00003022
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Memorial Sloan Kettering Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Kim Kramer, MD
Principal Investigator Affiliation Memorial Sloan Kettering Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors, Intraocular Melanoma, Lung Cancer, Melanoma (Skin), Neuroblastoma, Retinoblastoma, Sarcoma
Additional Details

OBJECTIVES:

  • - Define the clinical toxicities of intrathecal iodine I 131 monoclonal antibody 3F8 (I-3F8) in patients with GD2 positive leptomeningeal neoplasms.
  • - Determine whether I-3F8 can detect GD2 positive leptomeningeal tumors.
  • - Measure the cerebrospinal fluid (CSF) levels and serum pharmacokinetics of I-3F8 in these patients.
OUTLINE: This is a dose escalation study. Patients receive a single injection of intraventricular or intrathecal iodine I 131 monoclonal antibody 3F8. Patients without objective disease progression and no grade 3 or 4 toxicity 6 weeks after the first dose may receive a second injection. Cohorts of at least 3 patients are entered at escalating doses of I-3F8. If grade 3 or worse toxicity occurs in 1 or more of 3 patients at a given dose level, then 3 additional patients are accrued at that level. If 2 or more of 6 patients at a given dose level experience grade 3 or worse toxicity, then that dose is declared the maximum tolerated dose (MTD). Patients are followed weekly for 4 weeks. PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study over 2-3 years.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Memorial Sloan-Kettering Cancer Center, New York, New York

Status

Address

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021

Powered By