Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms


Phase 1
3 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Intraocular Melanoma, Lung Cancer, Melanoma (Skin), Neuroblastoma, Retinoblastoma, Sarcoma

Thank you

Trial Information

Phase I Study of Intrathecal 131-I-3F8 Monoclonal Antibody in Patients With GD2 Positive Leptomeningeal Neoplasms


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Kim Kramer, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000065607

NCT ID:

NCT00003022

Start Date:

April 1997

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Intraocular Melanoma
  • Lung Cancer
  • Melanoma (Skin)
  • Neuroblastoma
  • Retinoblastoma
  • Sarcoma
  • metastatic osteosarcoma
  • childhood infratentorial ependymoma
  • recurrent childhood rhabdomyosarcoma
  • childhood supratentorial ependymoma
  • regional neuroblastoma
  • disseminated neuroblastoma
  • stage 4S neuroblastoma
  • recurrent neuroblastoma
  • retinoblastoma
  • intraocular retinoblastoma
  • extraocular retinoblastoma
  • recurrent retinoblastoma
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • recurrent osteosarcoma
  • recurrent adult brain tumor
  • iris melanoma
  • ciliary body and choroid melanoma, small size
  • ciliary body and choroid melanoma, medium/large size
  • extraocular extension melanoma
  • recurrent intraocular melanoma
  • adult brain stem glioma
  • adult medulloblastoma
  • stage IV melanoma
  • recurrent melanoma
  • metastatic childhood soft tissue sarcoma
  • recurrent childhood soft tissue sarcoma
  • adult myxopapillary ependymoma
  • adult anaplastic ependymoma
  • adult anaplastic oligodendroglioma
  • adult mixed glioma
  • localized unresectable neuroblastoma
  • adult ependymoblastoma
  • recurrent childhood brain stem glioma
  • recurrent childhood supratentorial primitive neuroectodermal tumor
  • recurrent childhood visual pathway glioma
  • recurrent childhood medulloblastoma
  • recurrent childhood visual pathway and hypothalamic glioma
  • previously treated childhood rhabdomyosarcoma
  • localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • recurrent childhood ependymoma
  • adult oligodendroglioma
  • adult anaplastic astrocytoma
  • adult supratentorial primitive neuroectodermal tumor (PNET)
  • adult diffuse astrocytoma
  • adult pilocytic astrocytoma
  • adult giant cell glioblastoma
  • adult glioblastoma
  • adult gliosarcoma
  • Lung Neoplasms
  • Melanoma
  • Nervous System Neoplasms
  • Neuroblastoma
  • Retinoblastoma
  • Central Nervous System Neoplasms
  • Neuroectodermal Tumors, Primitive
  • Uveal Neoplasms
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Meningeal Neoplasms
  • Sarcoma

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021