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A Dose Escalation Study of NK-92 Cell Infusions in Patients With Hematological Malignancies in Relapse After Autologous Stem Cell Transplantation.

Phase 1
18 Years
Not Enrolling
Leukemia, Lymphoma, Myeloma, Hodgkin's Disease

Thank you

Trial Information

A Dose Escalation Study of NK-92 Cell Infusions in Patients With Hematological Malignancies in Relapse After Autologous Stem Cell Transplantation.

Patients with hematological malignancies such as acute leukemia, lymphoma, Hodgkin's disease
and myeloma, are generally treated initially with chemotherapy, radiotherapy or a
combination of both. High dose therapy and autotransplantation are often utilized in the
management of such patients, either as part of initial therapy or for treatment of relapsed
disease. When a patient's cancer relapses after transplantation, the prognosis is dismal.
Therapeutic options are usually limited to palliative chemotherapy and/or local radiation,
and for persons with excellent performance status experimental treatments are considered on
an ad hoc basis.

Much interest in the last decade has focused on the role of cellular and immunotherapy in
this setting. Cancer vaccines and the administration of adoptive cellular and immunotherapy
have the theoretical advantage of being non cross-reactive with previous treatments (such as
radiotherapy and chemotherapy) and are currently under investigation using a variety of
methodologies. NK cells comprise roughly 15% of all lymphocytes in the peripheral blood.
They normally function as part of the innate immune system, which provides the body's
initial response to infection and malignancy. However, patients with malignancies frequently
have impaired NK cell function, as evidenced by reduced in vitro proliferative responses and
reduced cytotoxic activity. The infusion of an irradiated NK cell line is appealing as it is
a source of cells that can be expanded to therapeutic quantities, and retains anti-tumor

Inclusion Criteria:

- Hematological malignancy (with prior histological confirmation) that has relapsed
after an autologous stem cell transplant and for which there is no known curative or
standard therapy. Specific hematological malignancies include acute myeloid leukemia,
acute lymphoblastic leukemia, non-Hodgkin's lymphoma, Hodgkin's disease and multiple

- Assessable disease as measured by clinical, radiological or bone marrow examinations

- ECOG performance status 0, 1 or 2

- Age ≥ 18 years

- Life expectancy greater than 12 weeks

- All patients must be informed of the investigational nature of this study and must
sign and give written informed consent in accordance with institutional and
University Human Experimentation Committee requirements.

- Adequate bone marrow, liver and renal function as assessed by the following
laboratory requirements: Absolute granulocytes ≥ 0.5 x 109/L, Platelets ≥ 50 x 109/L,
Serum creatinine < 1.5 x upper limit of normal, Bilirubin < 1.5 x upper limit of
normal, AST/ALT ≤ 3 x upper limit of normal, Calcium < 1.25 x upper limit of normal.
These tests must be conducted within 7 days prior to registration.

- Must be able to come to Princess Margaret Hospital, Toronto, Canada for treatment and

Exclusion Criteria:

- Pregnant or nursing women may not participate.

- Men or women of reproductive potential may not participate unless they agree to
practice an effective method of birth control. Women of childbearing potential must
have a negative pregnancy test performed within 7 days prior to registration.

- Concurrent treatment, or treatment within 28 days of registration with other
experimental drugs or anticancer therapy. Exceptions to this are: Patients who are
receiving or who have received radiation therapy less than four weeks prior to study
entry will not be excluded providing the volume of bone marrow treated is less than
10% and that the patient has measurable disease outside the radiation field.
Hydroxyurea may be administered to patients with high white cell counts but must be
discontinued at least 48 hours prior to the NK-92 cell infusions

- Patients with CNS involvement

- Known HIV, HBV or HCV infection

- Serious illness or medical condition which would not permit the patient to be managed
according to the protocol, including active uncontrolled infection, major
cardiovascular events within 3 months of registration, or psychiatric or emotional

- Patients with hypersensitivity or previous severe reactions to Allopurinol,
Acetominophen or Benadryl and all available alternative medications.

Type of Study:


Study Design:

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

Outcome Measure:

Determine if there are any dose limiting toxicities to this therapy, as well as the maximum tolerated dose.

Outcome Time Frame:

Day 1, 3, and 5 of each cycle

Safety Issue:


Principal Investigator

Armand Keating, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada


Canada: Health Canada

Study ID:




Start Date:

March 2005

Completion Date:

December 2012

Related Keywords:

  • Leukemia
  • Lymphoma
  • Myeloma
  • Hodgkin's Disease
  • natural killer cells
  • leukemia
  • lymphoma
  • myeloma
  • Hodgkin's disease
  • cell therapy
  • Hodgkin Disease
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Hematologic Neoplasms