Gemtuzumab in Treating Patients With Myelodysplastic Syndrome

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Monoclonal antibodies such as gemtuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: Randomized phase II trial to study the effectiveness of gemtuzumab in treating patients who have myelodysplastic syndrome.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jonsson Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Gemtuzumab

Criteria

DISEASE CHARACTERISTICS: Histologically confirmed myelodysplastic syndrome (MDS) Refractory anemia (RA) RA with ringed sideroblasts RA with excessive blasts (RAEB) RAEB in transformation (stable disease for at least 2 months) No chromosomal abnormalities including t(8;21), inv(16), or t(15;17) No chronic myelomonocytic leukemia proliferative type (WBC greater than 12,000/mm3) No known CNS involvement with MDS blast progression International Prognostic Scoring System (IPSS) score at least 1.5

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: See Disease Characteristics Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 2.0 mg/dL Cardiovascular: No severe cardiac disease Pulmonary: No severe pulmonary disease Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 1 year after study HIV negative No other prior active malignancy except basal cell or squamous cell skin cancer No uncontrolled infections

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior stem cell transplantation No prior anti-CD33 antibodies At least 4 weeks since prior hematopoietic growth factors, epoetin alfa, or cytokine therapy Chemotherapy: No prior chemotherapy for MDS or other malignancy No concurrent cytotoxic chemotherapy Endocrine therapy: At least 4 weeks since prior systemic steroids except topical or inhaled steroids No concurrent systemic steroids except topical or inhaled steroids Radiotherapy: No prior radiotherapy for MDS or other malignancy Surgery: No prior organ transplantation Other: At least 4 weeks since prior immunosuppressive therapy At least 4 weeks since prior investigational agents No concurrent immunosuppressive therapy No other concurrent investigational agents