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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006040 |
Purpose
RATIONALE: Radiolabeled monoclonal antibodies can locate cancer cells and deliver radiation to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of radiation and chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody therapy plus etoposide followed by peripheral stem cell transplantation in treating patients who have advanced myelodysplastic syndrome or refractory leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Biological: filgrastim Drug: etoposide Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: yttrium Y 90 monoclonal antibody M195 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | 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 |
| Study Start Date: | April 2000 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following diagnoses:
Acute lymphocytic leukemia with expression of CD33
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Peter Maslak, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000068055, MSKCC-99126, NCI-G00-1815 |
| Study First Received: | July 5, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00006040 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 myelodysplastic/myeloproliferative disease, unclassifiable |
|
Neoplasms by Histologic Type Disease Immunologic Factors Precancerous Conditions Antineoplastic Agents Hematologic Diseases Physiological Effects of Drugs Myelodysplastic Syndromes Myeloproliferative Disorders Etoposide phosphate Pharmacologic Actions Antibodies, Monoclonal |
Leukemia Antibodies Preleukemia Neoplasms Pathologic Processes Therapeutic Uses Syndrome Myelodysplastic-Myeloproliferative Diseases Bone Marrow Diseases Antineoplastic Agents, Phytogenic Etoposide |