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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.
Study NCT00068718.   Last updated on October 8, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Allogeneic Transplantation
Official Title  Donor Lymphocyte Infusion for the Treatment of Malignancy After Hematopoietic Cell Transplantation Using Nonmyeloablative Conditioning - A Multi-Center Trial
Brief Summary

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.

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.

Study Phase Phase I, Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure  Incidence of life threatening graft-vs-host disease (GVHD) [ Designated as safety issue: No ]
Secondary Outcome Measure  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: No ]
Chimerism [ Designated as safety issue: No ]
Infections [ Designated as safety issue: No ]
Condition  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
Intervention  Drug: therapeutic allogeneic lymphocytes
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  100
Start Date  May 2003
Completion Date
Eligibility 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)
Gender Both
Ages
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Germany,   Italy
Administrative Information Fields
NCT ID  NCT00068718
Organization ID CDR0000327819
Secondary IDs †† FHCRC-1803.00
Study Sponsor  Fred Hutchinson Cancer Research Center
Collaborators †† National Cancer Institute (NCI)
Investigators 
Principal Investigator:     Brenda Sandmaier, MD     Fred Hutchinson Cancer Research Center    
Information Provided By National Cancer Institute (NCI)
Verification Date September 2008
First Received Date  September 10, 2003
Last Updated Date October 8, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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