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A Phase I, Single Dose Escalating Study to Investigate the Tolerability, Pharmacokinetics and Dosimetry of 90 Y-Humanized MN-14 IgG in Colorectal Cancer Patients With Limited Residual Disease After Primary or Salvage Surgery


Phase 1
18 Years
N/A
Not Enrolling
Both
Colorectal Neoplasms

Thank you

Trial Information

A Phase I, Single Dose Escalating Study to Investigate the Tolerability, Pharmacokinetics and Dosimetry of 90 Y-Humanized MN-14 IgG in Colorectal Cancer Patients With Limited Residual Disease After Primary or Salvage Surgery


Disease Characteristics:

- Patients with documented histologic and cytologic diagnosis of colon or rectal
malignancy

- Patients with documented status post surgical resection of primary cancer or
metastases

- Limited residual disease (i.e., CEA serum levels < 15 ng/mL and negative baseline CT
scans, or no lesion > 1 cm)

Prior/Concurrent Therapy:

- Patients must have completed chemotherapeutic agents, biologic therapy, radiotherapy,
other investigational therapy for cancer, or surgical procedures at least six weeks
prior to study entry.

- Patients must have recuperated from surgery and toxicities (as a result of previous
therapy) sufficiently prior to study entry

- Biologic Therapy: Patients who have received a murine, chimeric, CDR-grafted
(humanized), or human IgG will be eligible provided pre-study evaluations demonstrate
no significant reactivity with hMN-14 IgG (i.e., HAHA)

- Radiotherapy: No prior external beam irradiation to a field that includes more than
30% of the red marrow. No prior radiation to maximal tolerable levels for any
critical organs (e.g., 3000 cGy for the liver; 2000 cGy for the lungs and kidneys)

Patient Characteristics/

Inclusion Criteria:



- Performance Status: Patients with Karnofsky performance status > 70%

- Hematopoietic: ANC >/= 1.5 x 10/L; Hemoglobin >/= 10 g/dL; Platelets >/= 100 x 10/L

- Renal: Serum Creatinine
- Hepatic: Serum Bilirubin 2.5 x ULN

- Cardiovascular: Patients with LVEF >/= 50% by required MUGA/2D-ECHO tests

- Pulmonary: Patients with DF and FEV1 >/= 60% by required Pulmonary Function Tests

- Central Nervous System: Patients with known metastatic disease to the CNS are
excluded.

- Other: Patients agreeing to use a medically effective method of contraception during
and for a period of three months after the treatment period. A pregnancy test will be
preformed on each premenopausal female of childbearing potential immediately prior to
entry into study. Patients must understand and give written informed consent.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Lauri Welles, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Immunomedics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

IM-T-hMN14-06

NCT ID:

NCT00041691

Start Date:

Completion Date:

Related Keywords:

  • Colorectal Neoplasms
  • Colorectal Cancer
  • Colon Cancer
  • Rectal Cancer
  • Colorectal Neoplasms
  • Colorectal Carcinoma
  • Colorectal Tumor
  • Neoplasms
  • Colorectal Neoplasms

Name

Location

Virginia Mason Medical CenterSeattle, Washington  98111
Washington Hospital CenterWashington, District of Columbia  20010