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Phase I Study Of Intrathecal Radioimmunotherapy Using I-8H9 For Central Nervous System/Leptomeningeal Neoplasms

Phase 1
Open (Enrolling)
Brain and Central Nervous System Tumors, Neuroblastoma, Sarcoma

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Trial Information

Phase I Study Of Intrathecal Radioimmunotherapy Using I-8H9 For Central Nervous System/Leptomeningeal Neoplasms


Inclusion Criteria:

- Patients must have a histologically confirmed diagnosis of a malignancy known to be
8H9 reactive. 8H9 expression must be confirmed by immunohistochemical staining of
tumor and assessed by the Department of Pathology or by immunofluorescence of bone
marrow except for patients confirmed to have neuroblastoma.

- Patients must have CNS/ leptomeningeal disease which is refractory to conventional
therapies or for which no conventional therapy exists OR a recurrent brain tumors
with a predilection for leptomeningeal dissemination (medulloblastoma, PNET, rhabdoid

- Patients must have no rapidly progressing or deteriorating neurologic examination.

- Patients must have an absolute neutrophil count (ANC) > 1000/ul and a platelet count
> 50,000/ul.

- Patients may have active malignancy outside the central nervous system.

- Both pediatric and adult patients of any age are eligible.

- Patients or a legal guardian will sign an informed consent form approved by the IRB
and obtained by the Principal or a Co- Investigator before patient entry. Minors will
provide assent.

- Patients with stored stem cells will be treated at the escalating dose while patients
with no stem cells will be treated at the 50 mCi dose. Neuroblastoma patients can be
treated at the 50 mCi dose with or without stored stem cells.

Subject Exclusion Criteria:

- Patients with obstructive or symptomatic communicating hydrocephalus.

- Patients with an uncontrolled life-threatening infection.

- Patients who are pregnant: Pregnant women are excluded for fear of danger to the
fetus. Therefore negative pregnancy test is required for all women of child-bearing
age, and appropriate contraception is required during the study period.

- Patients who have received cranial or spinal irradiation less than 3 weeks prior to
the start of this protocol.

- Patients who have received systemic chemotherapy (corticosteroids not included) less
than 3 weeks prior to the start of this protocol.

- Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, and
gastrointestinal system toxicity should all be less than grade 2. Patients with
stable neurological deficits (because of their brain tumor) are not excluded.
Patients with <= 3 hearing loss are not excluded.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

to evaluate the Maximally Tolerated Dose (MTD)

Outcome Description:

In order to find the MTD, a dose escalation scheme will be employed with patients entering in cohorts of 3 at each dose level from 10 mCi to 60 mCi and a cohort of 6 at each dose level from 70 mCi to 100 mCi. Dose escalation is based on the Dose Limiting Toxicity (DLT), which is defined as grade 3 or 4 neurotoxicity clearly related to 8H9 (excluding headache, fever, vomiting, hyperglycemia, lymphopenia and anemia).

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Kim Kramer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2004

Completion Date:

July 2014

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Neuroblastoma
  • Sarcoma
  • leptomeningeal metastases
  • recurrent neuroblastoma
  • disseminated neuroblastoma
  • recurrent adult brain tumor
  • recurrent childhood medulloblastoma
  • recurrent childhood rhabdomyosarcoma
  • recurrent childhood soft tissue sarcoma
  • recurrent osteosarcoma
  • recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • childhood atypical teratoid/rhabdoid tumor
  • adult medulloblastoma
  • previously treated childhood rhabdomyosarcoma
  • metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
  • metastatic osteosarcoma
  • childhood desmoplastic small round cell tumor
  • metastatic childhood soft tissue sarcoma
  • adult rhabdomyosarcoma
  • recurrent adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • Nervous System Neoplasms
  • Neuroblastoma
  • Central Nervous System Neoplasms
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Meningeal Neoplasms
  • Sarcoma



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