CNS Cancer, Neuroblastoma, Sarcoma
Conditions
Brief summary
The purpose of this study is to find out whether the monoclonal antibody 8H9 is useful in finding tumors in your body. Antibodies are protein found naturally in blood. They can fasten themselves to bacteria and viruses. They can stimulate white cells and blood proteins to kill tumors. The antibody 8H9 was made from mouse white cells. The white cells that secrete this antibody have been made to live for ever. They manufacture large amounts of 8H9 for patient use. Although other monoclonal antibodies have been safely tested in people, the antibody 8H9 has never been given to a human patient.
Detailed description
To test if intravenous injections of iodine-131 labeled murine monoclonal antibody 8H9 can detect primary and metastatic solid tumors. A total of 60 patients will be accrued over a period of 2 years.
Interventions
DRUG131I-8H9
This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m\^2 dose \[intended specific activity of \ 20 mCi/mg protein\]
DRUG8H9
administration of 50mg/1.73m\^2 of unlabeled 8H9.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of pediatric/adolescent solid tumor (including neuroblastoma, rhabdomyosarcoma, Ewing's/PNET, osteosarcoma, brain tumors, desmoplastic small round cell tumor (DSRT) and other tumors that are 8H9-positive) confirmed by the MSKCC Department of Pathology. * Patient must have either recurrent disease or have \<20% chance of long term disease-free survival. * Patient must be at least 1 year old. Age can range from 1-50 years of age. * Patients should have measurable or evaluable disease. For tumor types that are known to be 8H9-positive, patients can be imaged after the diagnosis is made, prior to definitive surgery or surgery to confirm tumor recurrence. * Tumor tissue is or will be available for 8H9 immunostaining. For patients with tumor-types known to be 8H9-positive, surgical samples obtained after 131I- 8H9 imaging will be immunostained to confirm 8H9-reactivity. These tumor types include: neuroblastoma, rhabdomyosarcoma, osteosarcoma, DSRT, Ewing's Sarcoma/PNET), brain tumors (glioblastoma multiforme, mixed glioma, astrocytoma, ependymoma, medulloblastoma, schwannoma., meningioma). * If frozen tumor tissue is unavailable, and if bone marrow involvement is demonstrated by histology, 8H9 immunostaining by immunofluorescence will be carried out on patient's bone marrow. In this case, patients will be eligible for study if bone marrow 8H9 immunostaining is positive.
Exclusion criteria
* Severe major organ toxicity. Specifically, renal, cardiac, hepatic, pulmonary, gastrointestinal, and neurologic 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. * Clinically apparent infections. * History of allergy to iodine or mouse proteins. * Patients previously treated with mouse monoclonal antibodies are not eligible unless they have no circulating HAMA. * 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 used during the study period. * Patient's own tumor is negative by 8H9 immunostaining.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Toxicity is Measured by the Total Number of Participants Affected | 2 years | Safety and toxicity is measured by the total number of participants affected. Please see the adverse event table for the specifics for this protocol. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MAB 131-I LABELED 8H9 MAB 131-I LABELED 8H9: This is an open-label single arm study of 131I-8H9, injected intravenously at 10 mCi/1.73 m2 dose \[intended specific activity of \
20 mCi/mg protein\] preceded by administration of 50mg/1.73m2 of unlabeled 8H9. | 12 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of accrual | 4 |
| Overall Study | Not Treated | 7 |
| Overall Study | Patient Ineligible | 1 |
Baseline characteristics
| Characteristic | MAB 131-I LABELED 8H9 |
|---|---|
| Age, Categorical <=18 years | 5 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Gender Female | 5 Participants |
| Gender Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 5 |
| serious Total, serious adverse events | 4 / 5 |
Outcome results
Primary
Safety and Toxicity is Measured by the Total Number of Participants Affected
Safety and toxicity is measured by the total number of participants affected. Please see the adverse event table for the specifics for this protocol.
Time frame: 2 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MAB 131-I LABELED 8H9 | Safety and Toxicity is Measured by the Total Number of Participants Affected | 5 Participants |