Lymphocyte Infusion in Treating Patients With Relapsed Cancer After Bone Marrow or Peripheral Stem Cell Transplantation
|First Received Date ICMJE||November 1, 1999|
|Last Updated Date||November 28, 2011|
|Start Date ICMJE||August 1998|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00003887 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Lymphocyte Infusion in Treating Patients With Relapsed Cancer After Bone Marrow or Peripheral Stem Cell Transplantation|
|Official Title ICMJE||Donor Lymphocyte Infusion (DLI) as Adoptive Immunotherapy for Relapse Malignancies After Allogeneic Hematopoietic Transplantation|
RATIONALE: White blood cells from donors may be able to kill cancer cells in patients with cancer that has recurred following bone marrow or peripheral stem cell transplantation.
PURPOSE: Phase II trial to study the effectiveness of donated white blood cells in treating patients who have relapsed cancer following transplantation of donated bone marrow or peripheral stem cells.
OBJECTIVES: I. Offer donor lymphocyte infusion as adoptive immunotherapy in patients with relapsed malignancies after allogeneic bone marrow or peripheral blood stem cell transplantation and who are not eligible for other FHCRC protocols.
OUTLINE: Patients with rapidly progressive disease receive reinduction chemotherapy and radiotherapy prior to study therapy. Donor lymphocyte infusions (DLI) begin after recovery from chemotherapy or sooner, if clinically indicated. Patients receive 1 or more DLI from the original donor. Patients are followed monthly for 3 months, then every 3-6 months for 9 months.
PROJECTED ACCRUAL: An unlimited number of patients will be accrued for this study.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Primary Purpose: Treatment|
|Intervention ICMJE||Biological: peripheral blood lymphocyte therapy|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Enrollment ICMJE||Not Provided|
|Completion Date||February 2003|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
DISEASE CHARACTERISTICS: Diagnosis of relapsed malignancy after allogeneic transplantation Rapidly progressive malignancies (acute leukemias) should receive induction chemotherapy or radiotherapy prior to this study Persistent donor cells Must be able to tolerate a taper of steroids to a dosage of no greater than 0.25 mg/kg/day and be off all other immunosuppressive therapy for 2 weeks without significant flare of graft vs host disease (GVHD) No grade II-IV acute GVHD or extensive chronic GVHD Same donor as for prior transplant
PATIENT CHARACTERISTICS: Age: 1 to 70 Performance status: Karnofsky 30-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: HIV negative
PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: See Disease Characteristics At least 1 week since immunosuppressive therapy for advanced malignancy At least 2 weeks since immunosuppressive therapy for nonadvanced malignancy Radiotherapy: See Disease Characteristics Surgery: Not specified
|Ages||1 Year to 70 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00003887|
|Other Study ID Numbers ICMJE||600.03, FHCRC-600.03, NCI-H99-0031, CDR0000067056|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Fred Hutchinson Cancer Research Center|
|Collaborators ICMJE||National Cancer Institute (NCI)|
|Information Provided By||Fred Hutchinson Cancer Research Center|
|Verification Date||November 2011|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP