Radiolabeled Monoclonal Antibody Therapy and Etoposide Followed by Peripheral Stem Cell Transplantation in Treating Patients With Advanced Myelodysplastic Syndrome or Refractory Leukemia
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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 Neoplasms |
Biological: filgrastim Drug: etoposide Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: yttrium Y 90 monoclonal antibody M195 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: 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:
- 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.
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 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
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
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006040 History of Changes |
| Other Study ID Numbers: | CDR0000068055, MSKCC-99126, NCI-G00-1815 |
| Study First Received: | July 5, 2000 |
| Last Updated: | May 14, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
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 |
Additional relevant MeSH terms:
|
Neoplasms Leukemia Myelodysplastic Syndromes Preleukemia Myeloproliferative Disorders Myelodysplastic-Myeloproliferative Diseases Neoplasms by Histologic Type Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Antibodies Immunoglobulins |
Antibodies, Monoclonal Lenograstim Etoposide Etoposide phosphate Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Adjuvants, Immunologic |
ClinicalTrials.gov processed this record on May 19, 2013