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Phase I Study of Yttrium-90 Labeled HuM195 Combined With Etoposide as a Conditioning Regimen for Autologous Stem Cell Transplantation in Patients With Advanced Myelodysplastic Syndrome and Refractory Leukemia


Phase 1
18 Years
N/A
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms

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Trial Information

Phase I Study of Yttrium-90 Labeled HuM195 Combined With Etoposide as a Conditioning Regimen for Autologous Stem Cell Transplantation in Patients With Advanced Myelodysplastic Syndrome and Refractory Leukemia


OBJECTIVES:

- Determine the maximum tolerated dose of yttrium Y 90 humanized monoclonal antibody M195
when combined with etoposide as a preparative regimen for autologous peripheral blood
stem cell transplantation in patients with advanced myelodysplastic syndrome or
refractory leukemia.

- Determine the qualitative toxicities associated with this regimen in this patient
population.

- Assess preliminary information on engraftment following this conditioning regimen in
these patients.

OUTLINE: This is a dose escalation study of yttrium Y 90 humanized monoclonal antibody M195
(Y90 MOAB M195).

Patients receive Y90 MOAB M195 IV over 40 minutes once between days -12 to -9 and etoposide
IV over several hours on day -3. Peripheral blood stem cells or bone marrow are reinfused on
day 0. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 1 until
hematopoietic recovery.

Cohorts of 3-6 patients receive escalating doses of Y90 MOAB M195 until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3
of 6 patients experience dose limiting toxicities.

Patients are followed between days 10 and 14 and then monthly for 6 months.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for this study within 12 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- One of the following diagnoses:

- Acute myeloid leukemia

- Accelerated/blastic phase of a myeloproliferative disorder (i.e., greater than
10% blasts in bone marrow or presence of extramedullary disease)

- Myelodysplastic syndrome

- Acute lymphocytic leukemia with expression of CD33

- Greater than 20% blast population

- No evidence of CNS disease

- Relapsed after previously achieving complete remission

- Must have previously had peripheral blood stem cells or bone marrow cells harvested
and cryopreserved while in remission

- Greater than 25% of bone marrow blasts must be CD33 positive

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Not specified

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Not specified

Renal:

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 60 mL/min

Cardiovascular:

- LVEF greater than 50% by ECG or MUGA

- No history of cardiomyopathy or symptomatic congestive heart failure

Pulmonary:

- DLCO at least 50% predicted

Other:

- Not pregnant or nursing

- Negative pregnancy test

- HIV negative

- No other concurrent active malignancy

- No known sensitivity to E. coli derived products

PRIOR CONCURRENT THERAPY:

Biologic therapy

- See Disease Characteristics

Chemotherapy

- See Disease Characteristics

Endocrine therapy

- Not specified

Radiotherapy

- Not specified

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Peter Maslak, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

99-126

NCT ID:

NCT00006040

Start Date:

April 2000

Completion Date:

November 2003

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • Myelodysplastic/Myeloproliferative Neoplasms
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • previously treated myelodysplastic syndromes
  • atypical chronic myeloid leukemia, BCR-ABL1 negative
  • myelodysplastic/myeloproliferative neoplasm, unclassifiable
  • Neoplasms
  • Leukemia
  • Myelodysplastic Syndromes
  • Preleukemia
  • Myeloproliferative Disorders
  • Myelodysplastic-Myeloproliferative Diseases

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021