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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 Myeloid Leukemia and Myelodysplastic Syndrome


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 Myeloid Leukemia and Myelodysplastic Syndrome


OBJECTIVES:

- Determine the efficacy, in terms of overall survival and disease-free survival, and
toxicity of cyclophosphamide and total body irradiation in patients with acute myeloid
leukemia beyond first remission receiving HLA-matched related or unrelated
hematopoietic stem cell transplantation.

- Determine the maximum tolerated dose (MTD) of iodine I 131 monoclonal antibody BC8
(I131 MOAB BC8) in these patients.

- Estimate the MTD of radiation delivered by I 131 MOAB BC8 to marrow of these patients
and assess the effects on growth of marrow stroma in vitro.

OUTLINE: This is radiation dose-escalation study. Patients are stratified according to
available donor (related vs unrelated).

Patients receive a biodistribution dose of iodine I 131 monoclonal antibody BC8 (I131 MOAB
BC8) IV, then a therapeutic dose of I131 MOAB BC8 IV 6-14 days later (day -12). Patients
undergo total body irradiation twice daily on days -6 to -4. Patients receive
cyclophosphamide IV on days -3 and -2. Bone marrow cells (or peripheral blood stem cells)
are infused on day 0.

Patients with CNS leukemic involvement receive intrathecal methotrexate twice before the
transplantation then every other week for 8 weeks beginning on day 32. These patients also
receive cranial irradiation beginning on day 32.

Cohorts of 4 patients each receive escalating doses of iodine I 131 attached to a standard
dose of monoclonal antibody BC8 until the maximum tolerated dose (MTD) is determined. The
MTD is defined as the radiation dose preceding that at which 2 of up to 6 patients
experience graft failure.

Patients are followed at 6, 9, and 12 months, every 6 months for 1 year, and then annually
thereafter.

PROJECTED ACCRUAL: A total of 40 patients (20 per stratum) will be accrued for this study
within 4 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of 1 of the following:

- Acute myeloid leukemia (AML) beyond first remission OR with primary refractory
disease

- AML that has transformed from myelodysplastic syndromes, if induction
chemotherapy not recommended

- Documented CD45 expression in patients with relapsed disease

- Not needed for patients in remission

- Circulating blast count less than 10,000/mm^3 (may be controlled with hydroxyurea or
similar agent)

PATIENT CHARACTERISTICS:

Age

- 2 to 55

Performance status

- Not specified

Life expectancy

- More than 60 days

Hematopoietic

- See Disease Characteristics

Hepatic

- Bilirubin less than 1.5 mg/dL (unless bilirubin is determined by the gastroenterology
service to be predominantly unconjugated [indirect] as the result of possible
hemolysis)

- AST less than 1.5 times upper limit of normal (ULN)

Renal

- Creatinine less than 2.0 mg/dL OR less than 1.5 times ULN for age

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No major infection

- No circulating antibodies to mouse immunoglobulins

- HIV negative

- Able to tolerate diagnostic or therapeutic procedures (e.g., radiation isolation)

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- No radiotherapy to maximum tolerated levels to any normal organ

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Eneida Nemecek, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

1297.00

NCT ID:

NCT00003868

Start Date:

February 1999

Completion Date:

March 2005

Related Keywords:

  • Leukemia
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • secondary acute myeloid leukemia
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute myeloid leukemia with t(15;17)(q22;q12)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes

Name

Location
Fred Hutchinson Cancer Research Center Seattle, Washington  98109