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

This study has been terminated.
(low accrual)
Sponsor:
Collaborator:
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00469820
First received: May 3, 2007
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Leukemia
Multiple Myeloma and Plasma Cell Neoplasm
Biological: autologous tumor cell vaccine
Biological: peripheral blood lymphocyte therapy
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Posttransplant Immunotherapy With Donor Lymphocyte Infusions and Autologous Tumor Vaccines After HLA-Matched Transplant

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Time to relapse [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Safety and tolerability, in terms of incidence of graft-versus-host disease and local/systemic toxicities [ Designated as safety issue: Yes ]
  • Maximum tolerated dose of donor lymphocytes [ Designated as safety issue: Yes ]

Enrollment: 1
Study Start Date: April 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00469820

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Carol A. Huff, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00469820     History of Changes
Other Study ID Numbers: J06118 CDR0000543531, P01CA015396, P30CA006973, JHOC-J06118
Study First Received: May 3, 2007
Last Updated: March 20, 2014
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Neoplasms
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on August 28, 2014