Iodine I 131 Monoclonal Antibody 8H9 in Treating Patients with Desmoplastic Small Round Cell Tumors and Other Solid Tumors Involving the Peritoneum

Status: Active

Description

This phase I trial studies the side effects and best dose of iodine I 131 monoclonal antibody 8H9 in treating patients with small round cell tumors that cause or form adhesions or fibrous connective tissue within a tumor (desmoplastic) and other solid tumors involving the peritoneum. Radiolabeled monoclonal antibodies, such as iodine I 131 monoclonal antibody 8H9, can find tumor cells and carry tumor-killing substances to them without harming normal cells.

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
  • 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 131I-8H9 treatment; the minimum dose for hematopoietic stem cells is 2 x 10^6 cluster of differentiation (CD)34+ 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 National Cancer Institute [NCI] Common Toxicity Criteria [CTC] version 3 criteria) with the following exceptions: * Serum aspartate aminotransferase (AST), alanine aminotransferase (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 absolute neutrophil count (ANC) >= 500/uL
  • Platelet count should be > 50,000/ul and hemoglobin should be > 8 gm/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 human anti-murine antibody (HAMA) level of > 1000 U/ml
  • Active serious infections not controlled by antibiotics
  • Pregnant women and women who are breast feeding are excluded; 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

Locations & Contacts

New York

New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Shakeel Modak
Phone: 212-639-7623

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. Define the toxicity and maximal tolerated dose (MTD) of iodine I 131 monoclonal antibody 8H9 (131I-8H9) administered intraperitoneally.

SECONDARY OBJECTIVES:

I. Assess pharmacokinetics for intraperitoneal (IP) 131I-8H9.

II. Assess response of desmoplastic small round cell tumor (DSRCT) and other solid tumors to IP 131I-8H9.

OUTLINE: This is a dose-escalation study.

Patients receive iodine I 131 monoclonal antibody 8H9 IP on day 0.

After completion of study treatment, patients are followed up periodically.

Trial Phase & Type

Trial Phase

Phase I

Trial Type

Treatment

Lead Organization

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Shakeel Modak

Trial IDs

Primary ID 09-090
Secondary IDs NCI-2010-01242
Clinicaltrials.gov ID NCT01099644