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Sponsors and Collaborators: |
Cancer Institute of New Jersey National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00161187 |
RATIONALE: When irradiated lymphocytes from a donor are infused into the patient they may help the patient's immune system kill cancer cells.
PURPOSE: This phase II trial is studying the side effects and how well irradiated donor lymphocyte infusion works in treating patients with relapsed or refractory hematologic cancer or solid tumor.
Condition | Intervention | Phase |
---|---|---|
Cancer |
Drug: therapeutic allogeneic lymphocytes Procedure: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Active Control |
Official Title: | A Pilot Study of Irradiated HLA-Partially Matched Allogeneic Related Donor Lymphocytes for Patients With Selected Malignancies |
Estimated Enrollment: | 40 |
Study Start Date: | December 2000 |
OBJECTIVES:
OUTLINE: This is a pilot, open-label, controlled study.
Patients undergo irradiated allogeneic donor lymphocyte infusion over 1 hour on day 1. Treatment repeats every 8-16 weeks for up to 6 infusions in the absence of disease progression or unacceptable toxicity.
Blood samples are collected periodically and analyzed for lymphocytotoxicity directed towards patients' cells (normal and malignant cells) and for disease or antigen-specific cells. Samples are also analyzed for survival of donor lymphocytes by chimerism studies.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of 1 of the following:
Hematologic cancer, including any of the following:
Chronic lymphocytic leukemia or small lymphocytic lymphoma meeting any of the following criteria:
B- or T-cell prolymphocytic leukemia meeting any of the following criteria:
Lymphoplasmacytic lymphoma, marginal zone lymphoma, mucosa-associated lymphoid tissue lymphoma, or follicular lymphoma meeting any of the following criteria:
Multiple myeloma meeting any of the following criteria:
Diffuse large B-cell lymphoma meeting any of the following criteria:
Burkitt's lymphoma
Lymphomatoid granulomatosis or mature T-cell or NK-cell neoplasms meeting any of the following criteria:
Mycosis fungoides or Sezary syndrome
Anaplastic large cell lymphoma, peripheral T-cell lymphoma unspecified, or angioimmunoblastic T-cell lymphoma meeting the following criteria:
Hepatosplenic T-cell lymphoma or adult T-cell leukemia/lymphoma
Hodgkin's lymphoma
Acute lymphocytic leukemia meeting any of the following criteria:
Acute myelogenous leukemia or myelodysplasia meeting any of the following criteria:
Chronic myelogenous leukemia meeting any of the following criteria:
Solid tumor, including any of the following:
Renal cell carcinoma
Bladder cancer or gastric cancer
Prostate cancer
Testicular cancer
Pancreatic cancer
Hepatocellular carcinoma
Colorectal carcinoma
Breast cancer meeting any of the following criteria:
Lung cancer (non-small cell or small cell lung cancer), ovarian cancer, endometrial cancer, or cervical cancer
Malignant melanoma
Sarcoma meeting any of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, New Jersey | |
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | Recruiting |
New Brunswick, New Jersey, United States, 08903 | |
Contact: Clinical Trials Office - Cancer Institute of New Jersey 732-235-8675 |
Principal Investigator: | Roger Strair, MD, PhD | Cancer Institute of New Jersey |
Study ID Numbers: | CDR0000540298, CINJ-3330 |
Study First Received: | September 8, 2005 |
Last Updated: | November 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00161187 |
Health Authority: | Unspecified |
refractory chronic lymphocytic leukemia recurrent small lymphocytic lymphoma prolymphocytic leukemia extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue nodal marginal zone B-cell lymphoma recurrent marginal zone lymphoma splenic marginal zone lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma recurrent mantle cell lymphoma childhood diffuse large cell lymphoma |
recurrent adult diffuse large cell lymphoma recurrent adult Burkitt lymphoma recurrent adult grade III lymphomatoid granulomatosis recurrent childhood grade III lymphomatoid granulomatosis adult nasal type extranodal NK/T-cell lymphoma childhood nasal type extranodal NK/T-cell lymphoma recurrent mycosis fungoides/Sezary syndrome anaplastic large cell lymphoma angioimmunoblastic T-cell lymphoma recurrent adult T-cell leukemia/lymphoma recurrent adult Hodgkin lymphoma recurrent/refractory childhood Hodgkin lymphoma recurrent adult acute myeloid leukemia recurrent childhood acute myeloid leukemia childhood chronic myelogenous leukemia |
Blast Crisis Sezary syndrome Chronic myelogenous leukemia Hodgkin lymphoma, adult Malignant mesenchymal tumor Small non-cleaved cell lymphoma Lymphomatoid granulomatosis Ewing's sarcoma Preleukemia Leukemia, Prolymphocytic Lung Neoplasms Neoplasm Metastasis Lymphoma, Large-Cell, Anaplastic Neuroepithelioma Rectal cancer |
Rhabdomyosarcoma Myelodysplastic syndromes Non-small cell lung cancer Precursor Cell Lymphoblastic Leukemia-Lymphoma Acute myelogenous leukemia Breast Neoplasms Testicular Neoplasms Leukemia, Myeloid Carcinoma Waldenstrom Macroglobulinemia Leukemia, Myeloid, Accelerated Phase B-cell lymphomas Sarcoma Uterine sarcoma Anaplastic large cell lymphoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial |