Radiolabeled Monoclonal Antibody Therapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Metastatic or Recurrent Colorectal Cancer or Pancreatic Cancer
Condition: Colorectal Cancer; Pancreatic Cancer
MeSH terms: Colorectal Neoplasms; Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and deliver
      tumor-killing substances to them without harming normal cells. Peripheral stem cell
      transplantation may be able to replace immune cells that were destroyed by monoclonal
      antibody therapy used to kill tumor cells.

      PURPOSE: Phase I/II trial to study the effectiveness of radiolabeled monoclonal antibody plus
      peripheral stem cell transplantation in treating patients who have metastatic or recurrent
      colorectal cancer or pancreatic cancer that has not responded to previous treatment.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose and secondary organ toxicity of high dose
      yttrium Y 90 monoclonal antibody MN-14 (90Y-hMN-14) plus autologous peripheral blood stem
      cell rescue in patients with metastatic or recurrent colorectal or pancreatic cancer. II.
      Compare the tumor to organ dose ratio between 90Y-hMN-14 and iodine 131 monoclonal antibody
      MN-14 (131I-MN-14) in these patients. III. Determine the antitumor effects with myeloablative
      doses of 90Y-hMN-14. IV. Evaluate the immunogenicity of 90Y-hMN-14 in these patients.

      OUTLINE: This is a dose escalation of yttrium Y 90 monoclonal antibody MN-14 (90Y-hMN-14),
      multicenter study. Patients are stratified by prior radiotherapy (yes vs no). Patients
      receive filgrastim (G-CSF) subcutaneously on days -18 to -14 and peripheral blood stem cell
      (PBSC) collection on days -15 to -13. If an adequate number of CD34+ cells are not harvested,
      bone marrow is also collected. Patients receive pretherapy imaging with indium In 111
      monoclonal antibody MN-14 (IN111-MN-14) IV on days -7 to 0. Patients receive 90Y-hMN-14 for
      up to 40 minutes on day 0. PBSC are reinfused on days 7 to 14. Patients receive G-CSF SQ
      until blood counts recover. Cohorts of 3-6 patients receive escalating doses of 90Y-hMN-14
      until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which
      2 of 3 or 2 of 6 patients experience dose limiting toxicity. Patients are followed at 1-4, 6,
      8, 12, and 24 weeks, and then every 6 months thereafter for up to 5 years.

      PROJECTED ACCRUAL: A total of 24-30 patients will be accrued for this study within 2 years.
    

Intervention name(s): filgrastim; autologous bone marrow transplantation; peripheral blood stem cell transplantation; indium In 111 monoclonal antibody MN-14; yttrium Y 90 monoclonal antibody MN-14
Intervention type(s): Biological; Procedure; Procedure; Radiation; Radiation
Intervention description(s): as prescribed by physician; 1-2 weeks before treatment; 1-2 weeks before treatment; intravenous infusion over 30 min; single dose; intravenous infusion over 30 min; single dose
Intervention MeSH terms: Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV colon cancer; stage IV pancreatic cancer; recurrent pancreatic cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer