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 - Full Text View

Sponsors and Collaborators:	Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00469820

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

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Multiple Myeloma

U.S. FDA Resources

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

Further study details as provided by National Cancer Institute (NCI):

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 ]

Estimated Enrollment:	30
Study Start Date:	June 2007
Estimated Primary Completion Date:	December 2009 (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

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

Locations

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Recruiting
Baltimore, Maryland, United States, 21231-2410
Contact: Clinical Trials Office - Sidney Kimmel Comprehensive Cancer Ce 410-955-8804 jhcccro@jhmi.edu

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Carol A. Huff, MD

Sidney Kimmel Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000543531, JHOC-J06118
Study First Received:	May 3, 2007
Last Updated:	February 10, 2009
ClinicalTrials.gov Identifier:	NCT00469820 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Leukemia, Lymphoid
Immunoproliferative Disorders
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Diseases
Blood Protein Disorders
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Leukemia, Myeloid
Hemostatic Disorders
Leukemia, Myeloid, Acute
Recurrence

Multiple Myeloma
Leukemia
Lymphatic Diseases
Acute Myelocytic Leukemia
Hemorrhagic Disorders
Acute Myeloid Leukemia, Adult
Neoplasm Metastasis
Congenital Abnormalities
Lymphoproliferative Disorders
Lymphoma
Acute Lymphoblastic Leukemia
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Blood Protein Disorders
Vascular Diseases
Paraproteinemias
Leukemia, Myeloid

Hemostatic Disorders
Leukemia, Myeloid, Acute
Multiple Myeloma
Leukemia
Lymphatic Diseases
Neoplasms
Hemorrhagic Disorders
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 06, 2009