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

NCT01099644

Description:

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.

Related Conditions:
  • Desmoplastic Small Round Cell Tumor
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

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

Title

  • 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
  • Clinical Trial IDs

    NCT ID: NCT01099644

    ORG ID: 09-090

    Trial Conditions

    Peritoneal Cancer

    Trial Interventions

    Drug Synonyms Arms

    Trial 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.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    131 I-8H9/ 124 I-8H9 Experimental 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.

    Eligibility 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.

    Minimum Eligible Age: 1 Year

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    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 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.

    Trial Keywords

    Peritoneum

    Desmoplastic Small Round Cell Tumors

    Intraperitoneal Radioimmunotherapy

    131 I-8H9

    09-090