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Phase I/II Radioimmunotherapy With High-Dose 90Y-Labeled Humanized MN-14 in Advanced Metastatic Colorectal Cancer and Pancreatic Cancers Using Autologous Peripheral Blood Stem Cell Rescue (PBSCR) to Control Myelotoxicity


Phase 1/Phase 2
18 Years
80 Years
Not Enrolling
Both
Colorectal Cancer, Pancreatic Cancer

Thank you

Trial Information

Phase I/II Radioimmunotherapy With High-Dose 90Y-Labeled Humanized MN-14 in Advanced Metastatic Colorectal Cancer and Pancreatic Cancers Using Autologous Peripheral Blood Stem Cell Rescue (PBSCR) to Control Myelotoxicity


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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically proven metastatic or recurrent
colorectal or pancreatic cancer for which no curative surgery exists Failed at least 1
regimen of standard fluorouracil based chemotherapy for metastatic colorectal cancer or
gemcitabine for pancreatic cancer Autologous peripheral blood stem cells (PBSC) or bone
marrow available Diffuse bone marrow involvement allowed if: Autologous bone marrow or
PBSC with no greater than 5% tumor involvement available Tumor site at least 2.0 cm in
diameter confirmed by pretherapy indium In 111 monoclonal antibody MN-14 imaging and CT
scan

PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: Karnofsky 70-100% ECOG 0-2 Life
expectancy: At least 3 months Hematopoietic: WBC at least 3,000/mm3 Granulocyte count at
least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2
mg/dL SGOT no greater than 2.0 times upper limit of normal (ULN) Renal: Creatinine no
greater than ULN Other: No severe anorexia, nausea, or vomiting No concurrent significant
medical complications that would preclude compliance Not pregnant Fertile patients must
use effective contraception during and for 3 months after study No allergy to 90Y-hMN-14

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior murine monoclonal antibody allowed
Chemotherapy: No prior irinotecan At least 4 weeks since prior chemotherapy and recovered
(8 weeks since nitrosourea, mitomycin or 90Y-hMN-14) Endocrine therapy: Not specified
Radiotherapy: At least 4 weeks since prior radiotherapy to index lesion and recovered No
prior radiotherapy to greater than 25% of red marrow (pelvic field radiation as adjuvant
therapy for rectal cancer allowed) No prior radiotherapy to maximum tolerated dose to any
critical organ (e.g., lung, liver, or kidney) Surgery: At least 4 weeks since major
surgery

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

maximum tolerated dose

Outcome Time Frame:

12 weeks

Safety Issue:

No

Principal Investigator

Jack D. Burton, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Garden State Cancer Center at the Center for Molecular Medicine and Immunology

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000067300

NCT ID:

NCT00004087

Start Date:

March 1997

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • Pancreatic Cancer
  • stage IV colon cancer
  • stage IV pancreatic cancer
  • recurrent pancreatic cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms
  • Pancreatic Neoplasms

Name

Location
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
St. Joseph's Hospital and Medical Center Paterson, New Jersey  07503
Garden State Cancer Center Belleville, New Jersey  07103