The purpose of this study is to test the safety of a new medicine called antibody 8H9
injected into the lining of the abdomen or peritoneum, where the tumor is. This medicine is
an antibody or protein which binds to certain tumors, including DSCRT. There is a small
number of DSCRT which do not bind with 8H9. If the tumor does not bind with 8H9, you might
not benefit from this treatment. The investigators want to find out what effects, good
and/or bad, it has.
This antibody is made in mice. Radioactive iodine can be bound to this antibody to deliver
radiation to the tumor. The investigators wish to determine the safety of radiolabeled 8H9
at different dose levels. This is the first study using 131I-8H9 in the peritoneum.
- Patients must have the diagnosis of (a) DSRCT with peritoneal involvement or (b)
other 8H9-positive solid tumors involving the peritoneum (e.g. adrenocortical
carcinoma, Wilm's tumor).
- For tumors other than DSRCT, patients must have a history of tumor progression or
recurrence or failure to achieve complete response with standard therapy or <20%
chance of long term disease-free survival.
- For tumors other than DSRCT, 8H9 reactivity must be confirmed by
- Patients with DSCRT are not required to have measurable or evaluable disease.
- Patients with tumors other than DSRCT without measurable or evaluable disease will
only be considered if they have <20% chance of long term disease-free survival.
- Prior Therapy: At least 4 weeks should have elapsed since any biologic therapy, or
immunotherapy. Three weeks should have elapsed since last dose of chemotherapy or
- Age >1 year and able to cooperate with radiation safety restrictions during therapy
- Stem cells: Patients must have an autologous hematopoietic stem cell product
cryopreserved and available for re-infusion after 131 I-8H9 treatment. The minimum
dose for hematopoietic stem cells is 2 x 106 CD34+ cells/kg.
- Minimum life expectancy of six weeks as determined by consenting professional.
- Signed informed consent indicating awareness of the investigational nature of this
- Severe major organ toxicity. Renal, cardiac, hepatic, pulmonary, gastrointestinal and
neurologic toxicity should all be grade 1 or less (per NCI CTC version 3 criteria)
with the following exceptions: serum AST,ALT and alkaline phosphatase should be 5 x
upper limit of normal (ULN), serum bilirubin 3 x ULN and nausea and vomiting should
be grade 2 Patients with myelosuppression are not excluded if ANC 500/uL.
- Platelet count should be > 50,000/ul and hemoglobin should be > 8gm/dl. Patients may
receive platelet or red blood cell transfusions to maintain hemoglobin and platelets
at clinical appropriate levels.
- Patients with clinically suspected dense intraperitoneal adhesions preventing
adequate IP distribution.
- History of allergy to mouse proteins.
- Patients previously treated with murine monoclonal antibodies will be excluded if
they have a HAMA level of >1000U/ml.
- Active serious infections not controlled by antibiotics.
- Pregnant women and women who are breast feeding are excluded for fear of danger to
the fetus/infant. Therefore negative pregnancy test is required for all women of
child-bearing age, and appropriate contraception is used during the study period.
Pregnancy testing will be carried out within two weeks prior to administration of
radioiodinated 8H9 in females of childbearing age.
- Inability or unwillingness to comply with radiation safety procedures or protocol
Minimum Eligible Age: 1 Year
Maximum Eligible Age: N/A
Eligible Gender: Both
Define maximal tolerated dose (MTD) of 131I-8H9 administered intraperitoneally
Assess tumor targeting of IP 124I-8H9.
Assess dosimetry for IP 124I-8H9.
Assess biodistribution for IP 124I-8H9.
Assess pharmacokinetics for IP 131I-8H9
Assess response of DSRCT and other solid tumors to IP 131 I-8H9.