Intraperitoneal Radioimmunotherapy With 131I-8H9 for Patients With Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum

This study is currently recruiting participants.
Verified October 2013 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01099644
First received: April 6, 2010
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Peritoneal Cancer
Biological: 131 I-8H9/ 124 I-8H9
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Define the toxicity of 131I-8H9 administered intraperitoneally. [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Define maximal tolerated dose (MTD) of 131I-8H9 administered intraperitoneally [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Assess tumor targeting of IP 124I-8H9. [ Time Frame: between days 24 and 38 ] [ Designated as safety issue: No ]
  • Assess dosimetry for IP 124I-8H9. [ Time Frame: (3-5 scans over the 3 days post-124I-8H9) 1 scan at ~5 days post-131I-8H9 administration), respectively, as well as serial blood sampling ] [ Designated as safety issue: No ]
  • Assess biodistribution for IP 124I-8H9. [ Time Frame: Day 8: Gamma camera scan for 131I-8H9 biodistribution ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Assess response of DSRCT and other solid tumors to IP 131 I-8H9. [ Time Frame: between days 24 and 38 ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: April 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 131 I-8H9/ 124 I-8H9
This is a phase I study of 131I-8H9 for patients with DSRCT and other 8H9-reactive solid tumors metastatic to the peritoneum. A tracer dose of 2mCi 124I-8H9 is administered intraperitoneally on day 0 followed by blood draws for pharmacokinetic and dosimetry studies and by serial whole body PET scans.
Biological: 131 I-8H9/ 124 I-8H9
Patients will first be administered A tracer dose of 2mCi 124I-8H9 is administered intraperitoneally on day 0 followed by blood draws for pharmacokinetic and dosimetry studies and by serial whole body PET scans. A therapeutic dose of 131I-8H9 will be administered 3 days after the dosimetry dose followed by blood draws for 131I-8H9 pharmacokinetic studies.

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 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-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 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 8H9 in females of childbearing age.
  • Inability or unwillingness to comply with radiation safety procedures or protocol requirements.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01099644

Contacts
Contact: Shakeel Modak, MD 212-639-7623
Contact: Nai-Kong Cheung, M.D., Ph.D. 646-888-2313

Locations
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Shakeel Modak, MD    212-639-7623      
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Shakeel Modak, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT01099644     History of Changes
Other Study ID Numbers: 09-090
Study First Received: April 6, 2010
Last Updated: October 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Peritoneum
Desmoplastic Small Round Cell Tumors
Intraperitoneal Radioimmunotherapy
131 I-8H9
09-090

Additional relevant MeSH terms:
Peritoneal Neoplasms
Desmoplastic Small Round Cell Tumor
Abdominal Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
N-(2-aminoethyl)-5-isoquinolinesulfonamide
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014