Study of Gelonin Purging of Autologous Stem Cells for Transplantation

• Status: Terminated
• Trial end date: 2005-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with Acute Myelogenous Leukemia or Myelodysplastic are able to achieve a complete remission but fail to achieve a prolonged disease-free survival. High dose chemotherapy and autologous bone marrow transplantation has been shown to be effective in this group of patients but hematopoietic recovery is slow, and infectious or bleeding complications are common. The delay in hematopoietic recover is accentuated by the use of purging techniques. This is a novel purging approach for autologous stem cell transplantation in patients with Acute Myelogenous Leukemia or Myelodysplastic syndrome to allow for rapid engraftment with a lower relapse rate therefore improving the therapeutic outcomes

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Busulfan; Fludarabine; Fludarabine phosphate; GEL protein, Gelonium multiflorum; Vidarabine

Criteria

Inclusion Criteria:

• Patients with AML, RAEB-t, RAEB, or CMML who are in first remission and have poor prognosis cytogenetic abnormalities (i.e: deletions of chromosome 5, 7, 20; trisomy 8, t9,22,11q23 abnormalities or complex karyotypes).*

• Patients with AML, RAEB-t, RAEB, or CMML who are in second or subsequent remission.

• Remission is defined as ANC>1.5 x 109/Lt; Platelet count >100 x 109/Lt, and red cell transfusion independence.

• Male or female who have provided written informed consent.

• Tumor cells must be > 80 % CD-33 positive by flow cytometry.

• For women of childbearing potential (i.e., exclude post-menopausal women, women who have been surgically sterilized), adequate birth control methods must be used. Acceptable birth control methods are limited to oral contraceptives, implants, diaphragm, IUD or spermicide used with a condom)

• No chemotherapy for the two weeks prior to entering the study.

• No evidence of residual toxic effects from prior chemotherapy.

• Patients with proven bacterial infection are not eligible until resolution of the infection (patient afebrile, not on steroids). Patients with active fungal infections are eligible only if evidence of response to antifungal medications is documented and they do not have fever exceeding 38C.

• Must have at least 5 x 106 CD34+ peripheral blood stem cells collected.

• All patients who have had less than 7 x 106 CD34+ cells/kg collected, should have a bone marrow harvest to serve as back-up.

• A minimum of 1 x 106 CD34+ cells/kg of unpurged bone marrow or 2 x 106 CD34+ cells/kg of unpurged peripheral blood need to be stored as backup to be eligible for this protocol.

• Patients must have bilirubin less than 2.0, transaminases less than 4 x upper limit of normal.

• Pulmonary function tests >50% predicted for DLCO, FVC and FEV1

• No active uncontrolled infection

• No active CNS disease

• No uncontrolled arrythmias

• Zubrod Performance Status less than or equal to 2

Exclusion Criteria:

• Active CNS disease