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. (see Contacts and Locations)
Verified April 2014 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: April 24, 2014
Last verified: April 2014

April 6, 2010
April 24, 2014
April 2010
April 2015   (final data collection date for primary outcome measure)
Define the toxicity of 131I-8H9 administered intraperitoneally. [ Time Frame: weekly ] [ Designated as safety issue: No ]
Define the toxicity of 131I-8H9 administered intraperitoneally. [ Time Frame: twice-weekly ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01099644 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Intraperitoneal Radioimmunotherapy With 131I-8H9 for Patients With Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum
Phase I Study of Intraperitoneal Radioimmunotherapy With 131I-8H9 for Patients With Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peritoneal Cancer
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.
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.
Intervention: Biological: 131 I-8H9/ 124 I-8H9
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
April 2015
April 2015   (final data collection date for primary outcome measure)

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.
Both
1 Year and older
No
Contact: Shakeel Modak, MD 212-639-7623
Contact: Nai-Kong Cheung, M.D., Ph.D. 646-888-2313
United States
 
NCT01099644
09-090
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Shakeel Modak, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP