Intraperitoneal Radioimmunotherapy With 131I-8H9 for Patients With Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum
Primary Purpose
Peritoneal Cancer
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
131 I-8H9
Sponsored by
About this trial
This is an interventional treatment trial for Peritoneal Cancer focused on measuring Peritoneum, Desmoplastic Small Round Cell Tumors, Intraperitoneal Radioimmunotherapy, 131 I-8H9, 09-090
Eligibility Criteria
Inclusion Criteria:
- Patients must have the diagnosis of (a) DSRCT with peritoneal involvement or (b) other Burtomab-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, Burtomab reactivity must be confirmed by immunohistochemistry.
- 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 radiotherapy.
- Age >1 year and able to cooperate with radiation safety restrictions during therapy period.
- Stem cells: Patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after 131 I-Burtomab 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 program.
Exclusion Criteria:
- 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 Burtomab in females of childbearing age.
- Inability or unwillingness to comply with radiation safety procedures or protocol requirements.
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
131 I-8H9
Arm Description
This is a phase I study of 131I-8H9 for patients with DSRCT and other 8H9-reactive solid tumors metastatic to the peritoneum.
Outcomes
Primary Outcome Measures
Define the toxicity of 131I-8H9 administered intraperitoneally.
Secondary Outcome Measures
Define maximal tolerated dose (MTD) of 131I-8H9 administered intraperitoneally
Assess pharmacokinetics for IP 131I-8H9
Assess response of DSRCT and other solid tumors to IP 131 I-8H9.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01099644
Brief Title
Intraperitoneal Radioimmunotherapy With 131I-8H9 for Patients With Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum
Official Title
Phase I Study of Intraperitoneal Radioimmunotherapy With 131I-8H9 for Patients With Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2010 (Actual)
Primary Completion Date
April 2020 (Actual)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Y-mAbs Therapeutics
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peritoneal Cancer
Keywords
Peritoneum, Desmoplastic Small Round Cell Tumors, Intraperitoneal Radioimmunotherapy, 131 I-8H9, 09-090
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
131 I-8H9
Arm Type
Experimental
Arm Description
This is a phase I study of 131I-8H9 for patients with DSRCT and other 8H9-reactive solid tumors metastatic to the peritoneum.
Intervention Type
Biological
Intervention Name(s)
131 I-8H9
Intervention Description
Patients will be administered therapeutic dose of IP 131I-8H9 per the dose escalation regimen. 131I-8H9 pharmacokinetics will be studied by serial blood draws from indwelling venous lines. 131I-8H9 biodistribution will be studied by a single gamma camera scan about 5 days after IP injection where feasible.
Primary Outcome Measure Information:
Title
Define the toxicity of 131I-8H9 administered intraperitoneally.
Time Frame
weekly
Secondary Outcome Measure Information:
Title
Define maximal tolerated dose (MTD) of 131I-8H9 administered intraperitoneally
Time Frame
5 years
Title
Assess pharmacokinetics for IP 131I-8H9
Time Frame
0 hrs, 60 mins, 2 hrs, 8 hrs, 18hrs, 30 hrs, 42hr, 66hrs, 90 hrs, and 114hrs.
Title
Assess response of DSRCT and other solid tumors to IP 131 I-8H9.
Time Frame
between days 24 and 38
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have the diagnosis of (a) DSRCT with peritoneal involvement or (b) other Burtomab-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, Burtomab reactivity must be confirmed by immunohistochemistry.
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 radiotherapy.
Age >1 year and able to cooperate with radiation safety restrictions during therapy period.
Stem cells: Patients must have an autologous hematopoietic stem cell product cryopreserved and available for re-infusion after 131 I-Burtomab 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 program.
Exclusion Criteria:
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 Burtomab in females of childbearing age.
Inability or unwillingness to comply with radiation safety procedures or protocol requirements.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shakeel Modak, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33119478
Citation
Modak S, Zanzonico P, Grkovski M, Slotkin EK, Carrasquillo JA, Lyashchenko SK, Lewis JS, Cheung IY, Heaton T, LaQuaglia MP, Cheung NV, Pandit-Taskar N. B7H3-Directed Intraperitoneal Radioimmunotherapy With Radioiodinated Omburtamab for Desmoplastic Small Round Cell Tumor and Other Peritoneal Tumors: Results of a Phase I Study. J Clin Oncol. 2020 Dec 20;38(36):4283-4291. doi: 10.1200/JCO.20.01974. Epub 2020 Oct 29.
Results Reference
derived
Links:
URL
http://www.mskcc.org
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Intraperitoneal Radioimmunotherapy With 131I-8H9 for Patients With Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum
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