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Radiolabeled BC8 (Anti-CD45) Antibody Combined With Cyclophosphamide and Total Body Irradiation Followed by HLA-matched Related or Unrelated Stem Cell Transplantation as Treatment for Advanced Acute Lymphocytic Leukemia


Phase 2
2 Years
55 Years
Not Enrolling
Both
Leukemia

Thank you

Trial Information

Radiolabeled BC8 (Anti-CD45) Antibody Combined With Cyclophosphamide and Total Body Irradiation Followed by HLA-matched Related or Unrelated Stem Cell Transplantation as Treatment for Advanced Acute Lymphocytic Leukemia


OBJECTIVES: I. Assess the efficacy and toxicity of iodine I 131 monoclonal antibody BC8,
cyclophosphamide, and total body irradiation in patients with advanced acute lymphocytic
leukemia who are receiving HLA matched related or unrelated bone marrow transplantation. II.
Determine the maximum tolerated dose (MTD) of iodine I 131 monoclonal antibody BC8 in these
patients. III. Estimate the MTD of radiation delivered by iodine I 131 monoclonal antibody
BC8 to the marrow. IV. Study the influence of marrow cellularity, level of antigen
expression by leukemic cells, and degree of antigen saturation by antibody on the
biodistribution of iodine I 131 monoclonal antibody BC8 in these patients.

OUTLINE: This is a dose-escalation study. All patients receive a test dose of iodine I 131
monoclonal antibody BC8 (MOAB BC8) IV over several hours 6-14 days prior to the therapeutic
dose. Patients receive the therapeutic dose of iodine I 131 MOAB BC8 IV over several hours
on day -11, total body irradiation over 30-40 minutes twice a day on days -6 to -4, and
cyclophosphamide IV over 1 hour on days -3 and -2. Patients undergo allogenic bone marrow
transplantation on day 0. Patients receive intrathecal methotrexate twice prior to
transplantation and then every other week for 4 weeks beginning on day 32 posttransplant.
Cohorts of 4 patients receive escalating doses of iodine I 131 monoclonal antibody until the
maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at
which 2 of 4 patients experience dose-limiting toxicity. Patients are followed for the first
100 days, at 6, 9 and 12 months, every 6 months for 1 year, and then annually thereafter.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed acute lymphocytic leukemia that is
beyond first remission or is refractory Relapsed disease must be CD45 positive Patients in
remission may be CD45 negative

PATIENT CHARACTERISTICS: Age: 2 to 55 Performance status: Not specified Life expectancy:
More than 60 days Hematopoietic: Circulating blast count less than 10,000/mm3 (control
with hydroxyurea or similar agent allowed) Hepatic: Bilirubin less than 1.5 mg/dL AST less
than 1.5 times upper limit of normal (ULN) Must have no veno-occlusive liver disease
Renal: Creatinine less than 2.0 mg/dL OR less than 1.5 times ULN for age Other: No active
infection HIV negative No circulating antimouse immunoglobulin antibodies Must be able to
tolerate diagnostic or therapeutic procedures (e.g., radiation isolation)

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to maximum tolerated
levels to any normal organ Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Dana Christine Matthews, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1298.00

NCT ID:

NCT00003870

Start Date:

February 1999

Completion Date:

November 2001

Related Keywords:

  • Leukemia
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent adult acute lymphoblastic leukemia
  • adult acute lymphoblastic leukemia in remission
  • childhood acute lymphoblastic leukemia in remission
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
University of Washington Medical CenterSeattle, Washington  98195-6043