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Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00068718
  Purpose

RATIONALE: White blood cells from donors may be able to kill cancer cells and prevent disease progression or relapse in patients who have undergone allogeneic bone marrow transplantation or allogeneic stem cell transplantation.

PURPOSE: This phase I/II trial is studying the side effects of donor lymphocyte infusion and to see how well it works in treating patients with persistent, relapsed, or progressing cancer after allogeneic bone marrow transplantation or stem cell transplantation.


Condition Intervention Phase
Chronic Myeloproliferative Disorders
Graft Versus Host Disease
Kidney Cancer
Leukemia
Lymphoma
Multiple Myeloma and Plasma Cell Neoplasm
Myelodysplastic Syndromes
Myelodysplastic/Myeloproliferative Diseases
Neuroblastoma
Ovarian Cancer
Sarcoma
Testicular Germ Cell Tumor
Drug: therapeutic allogeneic lymphocytes
Phase I
Phase II

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Kidney Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lymphoma Multiple Myeloma Neuroblastoma Ovarian Cancer Soft Tissue Sarcoma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Donor Lymphocyte Infusion for the Treatment of Malignancy After Hematopoietic Cell Transplantation Using Nonmyeloablative Conditioning - A Multi-Center Trial

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

Primary Outcome Measures:
  • Incidence of life threatening graft-vs-host disease (GVHD) [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disease response [ Designated as safety issue: No ]
  • Progression-free and overall survival [ Designated as safety issue: No ]
  • Acute and chronic GVHD [ Designated as safety issue: Yes ]
  • Chimerism [ Designated as safety issue: No ]
  • Infections [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: May 2003
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Determine the safety of donor lymphocyte infusion, in terms of the incidence of life-threatening graft-versus-host disease (GVHD), in patients with persistent, relapsed, or progressing malignancy after nonmyeloablative allogeneic transplantation.

Secondary

  • Determine disease response and progression-free and overall survival of patients treated with this regimen.
  • Determine chimerism in patients treated with this regimen.
  • Determine the grade of GVHD and infections in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study.

Patients receive unirradiated (viable) donor lymphocyte infusion (DLI) over 15-30 minutes on day 0. Patients may receive a second infusion after 4 weeks if no graft-versus-host disease (GVHD) develops and disease worsens, or after 8 weeks if disease status is unchanged and persistent donor T cells are documented.

To determine the safety of this regimen, all patients receive a standard initial dose of DLI and then, among patients requiring a second treatment, cohorts of 5-25 patients receive decreasing doses of DLI. Acceptable safety is determined by the regimen during which no more than 15% of patients experience morbid GVHD.

Patients are followed every 2 months for 6 months, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 5-100 patients will be accrued for this study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Persistent, relapsed, or progressing malignancy
  • Previously treated with a nonmyeloablative allogeneic transplantation from a related or unrelated donor comprising 2 Gy total body irradiation with or without fludarabine
  • Persistent donor CD3 cells (at least 5% donor CD3 cells by fluorescent in situ hybridization or variable number of tandem repeats)
  • Available leukapheresis product from the original donor of the hematopoietic cell transplantation (fresh unmodified or previously cryopreserved)
  • No current grade II to IV acute graft-versus-host disease (GVHD) or extensive chronic GVHD

PATIENT CHARACTERISTICS:

Age

  • Any age

Performance status

  • Karnofsky 50-100%

Life expectancy

  • Not specified

Hematopoietic

  • See Disease Characteristics

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics
  • No concurrent imatinib mesylate or interferon alfa

Chemotherapy

  • See Disease Characteristics
  • At least 3 weeks since prior salvage chemotherapy

Endocrine therapy

  • Concurrent steroids allowed provided patient can tolerate a taper to a dosage of no greater than 0.25 mg/kg/day within 1 to 2 weeks prior to study therapy without experiencing an increase in GVHD of at least 1 grade

Radiotherapy

  • See Disease Characteristics

Surgery

  • Not specified

Other

  • At least 2 weeks since prior immunosuppressive therapy (e.g., cyclosporine or mycophenolate mofetil) for nonadvanced malignancy (1 week for advanced malignancy)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00068718

Locations
United States, Oregon
Oregon Health and Science University Cancer Institute Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Clinical Trials Office - Oregon Health and Science University     503-494-1080     trials@ohsu.edu    
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109-1024
Contact: Brenda Sandmaier, MD     206-667-4961        
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109-1023
Contact: Clinical Trials Office - Seattle Cancer Care Alliance     800-804-8824        
University of Washington School of Medicine Recruiting
Seattle, Washington, United States, 98195
Contact: Clinical Trials Office - University of Washington School of Me     206-616-8289        
Veterans Affairs Medical Center - Seattle Recruiting
Seattle, Washington, United States, 98108
Contact: Thomas R. Chauncey, MD, PhD     206-762-1010        
United States, Wisconsin
Medical College of Wisconsin Cancer Center Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Clinical Trials Office - Medical College of Wisconsin Cancer C     414-805-4380        
Germany
Universitaet Leipzig Recruiting
Leipzig, Germany, D-04103
Contact: Dietger Niederwieser, MD     49-341-971-3050     dietger@medizin.uni_leipzig.de    
Italy
Azienda Sanitaria Ospedale San Giovanni Battista Molinette di Torino Recruiting
Turin, Italy, 10126
Contact: Benedetto Bruno, MD, PhD     39-339-112-9064     benedetto.bruno@unito.it    
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Brenda Sandmaier, MD Fred Hutchinson Cancer Research Center
  More Information

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

Responsible Party: Fred Hutchinson Cancer Research Center ( Brenda Sandmaier )
Study ID Numbers: CDR0000327819, FHCRC-1803.00
Study First Received: September 10, 2003
Last Updated: December 31, 2008
ClinicalTrials.gov Identifier: NCT00068718  
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
graft versus host disease
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult Burkitt lymphoma
recurrent adult Hodgkin lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult lymphoblastic lymphoma
recurrent cutaneous T-cell non-Hodgkin lymphoma
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
recurrent mantle cell lymphoma
recurrent neuroblastoma
recurrent ovarian epithelial cancer
recurrent ovarian germ cell tumor
recurrent malignant testicular germ cell tumor
refractory chronic lymphocytic leukemia
refractory hairy cell leukemia
relapsing chronic myelogenous leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
previously treated myelodysplastic syndromes
recurrent childhood acute lymphoblastic leukemia
recurrent childhood acute myeloid leukemia
recurrent/refractory childhood Hodgkin lymphoma
refractory multiple myeloma
chronic idiopathic myelofibrosis
recurrent Wilms tumor and other childhood kidney tumors
recurrent childhood rhabdomyosarcoma

Study placed in the following topic categories:
Chronic myelogenous leukemia
Malignant mesenchymal tumor
Hodgkin lymphoma, adult
Lymphoma, small cleaved-cell, diffuse
Urogenital Neoplasms
Lymphoma, large-cell, immunoblastic
Preleukemia
Hemorrhagic Disorders
Neuroepithelioma
Kidney Diseases
Rhabdomyosarcoma
Endocrine Gland Neoplasms
Myelodysplastic syndromes
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Hematologic Diseases
Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative
Blood Coagulation Disorders
Genital Neoplasms, Female
Acute myelogenous leukemia
Testicular Neoplasms
Leukemia, Myeloid
Carcinoma
Myelodysplastic myeloproliferative disease
B-cell lymphomas
Sarcoma
Lymphoma, Non-Hodgkin
Hairy cell leukemia
Neoplasms, Glandular and Epithelial
Precancerous Conditions
Blood Protein Disorders

Additional relevant MeSH terms:
Neoplasms
Pathologic Processes
Disease
Neoplasms by Site
Neoplasms by Histologic Type
Immune System Diseases
Syndrome
Neoplasms, Nerve Tissue
Cardiovascular Diseases
Neoplasms, Neuroepithelial
Adnexal Diseases

ClinicalTrials.gov processed this record on January 16, 2009