Lymphocyte Infusion in Treating Patients With Relapsed Cancer After Bone Marrow or Peripheral Stem Cell 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.

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Key information

Conditions

Breast Cancer Adnexal Diseases Blast Crisis Blood Protein Disorders Bone Marrow Diseases Breast Diseases Breast Neoplasms Burkitt Lymphoma Carcinogenesis Carcinoma Carcinoma, Embryonal Carcinoma, Ovarian Epithelial Cardiovascular Diseases Cell Transformation, Neoplastic Chronic Disease Chronic Myeloproliferative Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities DNA Virus Infections Dendritic Cell Sarcoma, Interdigitating Disease Attributes Endocrine Gland Neoplasms Endocrine System Diseases Endodermal Sinus Tumor Epstein-Barr Virus Infections Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Germinoma Gestational Trophoblastic Disease Gestational Trophoblastic Tumor Gonadal Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Herpesviridae Infections Histiocytic Disorders, Malignant Histiocytosis Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Infections Kidney Cancer Kidney Diseases Kidney Neoplasms Leukemia Leukemia, B-Cell Leukemia, Hairy Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Leukemia, Myeloid, Accelerated Phase Leukemia, Myeloid, Acute Leukemia, Myeloid, Chronic-Phase Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, B-Cell, Marginal Zone Lymphoma, Follicular Lymphoma, Large B-Cell, Diffuse Lymphoma, Large-Cell, Immunoblastic Lymphoma, Mantle-Cell Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Male Urogenital Diseases Mesonephroma Multiple Myeloma Multiple Myeloma and Plasma Cell Neoplasm Mycosis Fungoides Myelodysplastic Syndromes Myeloproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Complex and Mixed Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neoplasms, Plasma Cell Neoplastic Processes Neoplastic Syndromes, Hereditary Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Paraproteinemias Pathologic Processes Pathological Conditions, Signs and Symptoms Precursor Cell Lymphoblastic Leukemia-Lymphoma Precursor T-Cell Lymphoblastic Leukemia-Lymphoma Pregnancy Complications Pregnancy Complications, Neoplastic Primary Myelofibrosis Recurrence Sarcoma Seminoma Sezary Syndrome Skin Diseases Skin and Connective Tissue Diseases Teratoma Teratoma, Testicular Testicular Diseases Testicular Germ Cell Tumor Testicular Neoplasms Trophoblastic Neoplasms Tumor Virus Infections Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Vascular Diseases Virus Diseases Wilms Tumor

Age range

1 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

peripheral blood lymphocyte therapy

Biological

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study title

Donor Lymphocyte Infusion (DLI) as Adoptive Immunotherapy for Relapse Malignancies After Allogeneic Hematopoietic Transplantation

Important dates

Study start: 1998
Study completion: 2003
First posted: Apr 27, 2004
Registry last updated: Nov 30, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed