Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation - Full Text View

Sponsor:	Fred Hutchinson Cancer Research Center
Collaborator:	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	Biological: therapeutic allogeneic lymphocytes	Phase I Phase II

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

Resource links provided by NLM:

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

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 (TBI)-4 GY TBI or 2 GY TBI-4 GY TBI conditioning 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 systemic 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
Knight Cancer Institute at Oregon Health and Science University	Recruiting
Portland, Oregon, United States, 97239-3098
Contact: Clinical Trials Office - Knight Cancer Institute at Oregon Hea 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

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Brenda Sandmaier, MD

Fred Hutchinson Cancer Research 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

Responsible Party:	Fred Hutchinson Cancer Research Center ( Brenda Sandmaier )
Study ID Numbers:	CDR0000327819, FHCRC-1803.00
Study First Received:	September 10, 2003
Last Updated:	July 7, 2009
ClinicalTrials.gov Identifier:	NCT00068718 History of Changes
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

Additional relevant MeSH terms:

Neuroectodermal Tumors, Primitive
Urogenital Neoplasms
Urologic Neoplasms
Neoplasms, Connective and Soft Tissue
Preleukemia
Pathologic Processes
Neoplasms by Site
Hemorrhagic Disorders
Cardiovascular Diseases
Kidney Diseases
Endocrine Gland Neoplasms
Immunoproliferative Disorders
Immune System Diseases
Hematologic Diseases
Myeloproliferative Disorders

Genital Neoplasms, Female
Endocrine System Diseases
Carcinoma
Multiple Myeloma
Neuroectodermal Tumors
Neoplasms
Sarcoma
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial
Precancerous Conditions
Gonadal Disorders
Blood Protein Disorders
Neoplasms, Nerve Tissue
Paraproteinemias
Ovarian Diseases

ClinicalTrials.gov processed this record on November 09, 2009