Monoclonal Antibody Therapy in Treating Patients With Myelodysplastic Syndrome or Relapsed or Refractory Acute Myeloid Leukemia or Chronic Myelogenous Leukemia
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Purpose
RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells.
PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody in treating patients with myelodysplastic syndrome or relapsed or refractory acute myeloid leukemia or chronic myelogenous leukemia.
| Condition | Intervention | Phase |
|---|---|---|
|
Leukemia Myelodysplastic Syndromes |
Biological: lintuzumab |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | PHASE I DOSE-ESCALATION TRIAL OF YTTRIUM-90-LABELED HuM195 (HUMANIZED ANTI-CD33) IN PATIENTS WITH ADVANCED MYELOID MALIGNANCIES |
| Estimated Enrollment: | 24 |
| Study Start Date: | October 1996 |
| Primary Completion Date: | January 2001 (Final data collection date for primary outcome measure) |
OBJECTIVES: I. Determine the safety and toxicity of yttrium-90-labeled humanized monoclonal antibody M195 (90Y-MOAB HuM195) in patients with relapsed or refractory myeloid malignancies. II. Determine the pharmacology and dosimetry of 90Y-MOAB HuM195. III. Study the biological effects of 90Y-MOAB HuM195, including the ability to elicit human anti-human antibody responses and antileukemic responses.
OUTLINE: This study seeks to estimate the maximum tolerated dose (MTD) of yttrium-90-labeled humanized monoclonal antibody M195 (90Y-MOAB HuM195). All patients receive a single intravenous dose of 90Y-MOAB HuM195. Groups of 3 to 6 patients are treated at escalated doses of yttrium-90 until the MTD is determined. Patients with active leukemia who exhibit at least a 50% clearing of marrow blasts after the first dose may receive a second dose after 4-8 weeks provided remaining blasts are CD33-positive, there is no evidence of human anti-human antibody response, and any toxicity has resolved. All patients are followed monthly for 4 months after treatment.
PROJECTED ACCRUAL: Up to 24 patients will be treated. The study is expected to require 12-18 months to complete.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS: Pathologically confirmed myeloid malignancies as follows: Acute myelogenous leukemia that is relapsed or refractory after at least 2 courses of standard induction chemotherapy Accelerated or myeloblastic chronic myelogenous leukemia Refractory anemia with excess blasts (RAEB) RAEB in transformation Chronic myelomonocytic leukemia More than 25% of bone marrow blasts positive for the CD33 antigen Clear signs of active leukemia following recovery from prior therapy required No rapidly accelerating blast count No clinically unstable disease No active CNS leukemia
PATIENT CHARACTERISTICS: Age: Over 16 Performance status: Karnofsky 60%-100% Life expectancy: At least 6 weeks Hematopoietic: Not specified Hepatic: Bilirubin less than 2.5 mg/dL AST less than 3 times normal Alkaline phosphatase less than 3 times normal Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No NYHA class III/IV status Pulmonary: No clinically significant pulmonary disease Other: No serious infection uncontrolled by antibiotics No pregnant or nursing women Negative pregnancy test required of fertile women
PRIOR CONCURRENT THERAPY: Recovered from prior therapy Biologic therapy: No detectable antibodies to M195 from prior monoclonal antibody M195 or HuM195 Chemotherapy: At least 2 days since hydroxyurea At least 3 weeks since other chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since radiotherapy Surgery: Not specified
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Joseph G. Jurcic, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002890 History of Changes |
| Other Study ID Numbers: | CDR0000065213, MSKCC-96010, NCI-H96-1100 |
| Study First Received: | November 1, 1999 |
| Last Updated: | December 2, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent adult acute myeloid leukemia relapsing chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia refractory anemia with excess blasts |
refractory anemia with excess blasts in transformation chronic myelomonocytic leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes childhood myelodysplastic syndromes |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Myeloid, Acute Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Myelodysplastic Syndromes Preleukemia |
Neoplasms by Histologic Type Neoplasms Myeloproliferative Disorders Bone Marrow Diseases Hematologic Diseases Precancerous Conditions |
ClinicalTrials.gov processed this record on May 19, 2013