Vaccine Therapy With or Without Donor Lymphocyte Infusion in Treating Patients With Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Multiple Myeloma Undergoing Donor Stem Cell Transplant

Leukemia Clinical Trial

Official title:

Posttransplant Immunotherapy With Donor Lymphocyte Infusions and Autologous Tumor Vaccines After HLA-Matched Transplant

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00469820
• Other study ID #: J06118 CDR0000543531
• Secondary ID: P01CA015396P30CA
• Status: Terminated
• Phase: Phase 1
• First received: May 3, 2007
• Last updated: March 20, 2014
• Start date: April 2007
• Est. completion date: March 2010

Study information

• Verified date: March 2014
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid, Acute
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Biological:
• autologous tumor cell vaccine

• peripheral blood lymphocyte therapy

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to relapse			No
Primary	Overall survival			No
Primary	Safety and tolerability, in terms of incidence of graft-versus-host disease and local/systemic toxicities			Yes
Primary	Maximum tolerated dose of donor lymphocytes			Yes