Leukemia, Multiple Myeloma and Plasma Cell Neoplasm
Conditions
Keywords
adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(15;17)(q22;q12), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent adult acute lymphoblastic leukemia, recurrent adult acute myeloid leukemia, secondary acute myeloid leukemia, stage III multiple myeloma, untreated adult acute lymphoblastic leukemia, untreated adult acute myeloid leukemia, stage I multiple myeloma, stage II multiple myeloma, refractory multiple myeloma
Brief summary
RATIONALE: Vaccines made from the patient's cancer cells may help the body build an effective immune response to kill cancer cells. Giving vaccine therapy together with donor lymphocyte infusion after a stem cell transplant from the patient's brother or sister may kill any cancer cells that remain after transplant. PURPOSE: This clinical trial is studying the side effects, best dose, and how well vaccine therapy with or without donor lymphocyte infusion works in treating patients with acute myeloid leukemia, acute lymphoblastic leukemia, or multiple myeloma undergoing donor stem cell transplant.
Detailed description
OBJECTIVES: * Determine time to relapse and overall survival of patients with high-risk acute myeloid leukemia, acute lymphoblastic leukemia, or multiple myeloma treated with autologous tumor cell vaccine with or without donor lymphocyte infusion after HLA-matched related sibling nonmyeloablative hematopoietic stem cell transplantation. * Evaluate the safety and tolerability of this regimen in these patients. * Determine the maximum tolerated dose of donor lymphocyte infusions in these patients. OUTLINE: Patients undergo collection of tumor cells for production of the cancer cell vaccine and then undergo HLA-matched related sibling nonmyeloablative hematopoietic stem cell transplantation (HSCT). Patients then receive cancer cell vaccine with or without donor lymphocyte infusion. The donor lymphocytes are obtained from the same relative who donated stem cells for the HSCT. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Interventions
BIOLOGICALautologous tumor cell vaccine
BIOLOGICALperipheral blood lymphocyte therapy
Sponsors
National Cancer Institute (NCI)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Confirmed diagnosis of 1 of the following: * Acute myeloid leukemia (AML), meeting any of the following criteria: * Relapsed disease * AML arising from myelodysplastic syndromes * Primary refractory disease * De novo AML with high-risk features * Acute lymphoblastic leukemia (ALL), meeting any of the following criteria: * De novo ALL that is Philadelphia chromosome positive or with t(4,11) cytogenetic features * Relapsed disease * Multiple myeloma (in need of treatment) * Planning to undergo HLA-matched related sibling nonmyeloablative hematopoietic stem cell transplantation PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * See Disease Characteristics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to relapse | — |
| Overall survival | — |
| Safety and tolerability, in terms of incidence of graft-versus-host disease and local/systemic toxicities | — |
| Maximum tolerated dose of donor lymphocytes | — |
Countries
United States
Outcome results
None listed