NCT00161187

Brief Summary

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 pilot study is looking at the side effects and how well irradiated donor lymphocyte infusion works in treating patients with relapsed or refractory hematologic cancer or solid tumor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1 cancer

Timeline
Completed

Started May 2001

Longer than P75 for phase_1 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

November 6, 2015

Status Verified

September 1, 2013

Enrollment Period

9.4 years

First QC Date

September 8, 2005

Last Update Submit

November 5, 2015

Conditions

Cancer

Keywords

refractory chronic lymphocytic leukemiarecurrent small lymphocytic lymphomaprolymphocytic leukemiaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomarecurrent marginal zone lymphomasplenic marginal zone lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomastage I multiple myelomastage II multiple myelomastage III multiple myelomarecurrent mantle cell lymphomachildhood diffuse large cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult Burkitt lymphomarecurrent adult grade III lymphomatoid granulomatosisrecurrent childhood grade III lymphomatoid granulomatosisadult nasal type extranodal NK/T-cell lymphomachildhood nasal type extranodal NK/T-cell lymphomarecurrent mycosis fungoides/Sezary syndromeanaplastic large cell lymphomaangioimmunoblastic T-cell lymphomarecurrent adult T-cell leukemia/lymphomarecurrent adult Hodgkin lymphomarecurrent/refractory childhood Hodgkin lymphomarecurrent adult acute myeloid leukemiarecurrent childhood acute myeloid leukemiachildhood chronic myelogenous leukemiachronic phase chronic myelogenous leukemiarelapsing chronic myelogenous leukemiarecurrent renal cell cancerstage IV renal cell cancerrecurrent bladder cancerstage IV bladder cancerrecurrent prostate cancerstage IV prostate cancerrecurrent malignant testicular germ cell tumorstage III malignant testicular germ cell tumorrecurrent gastric cancerstage IV gastric cancerrecurrent pancreatic cancerstage IV pancreatic cancerlocalized unresectable adult primary liver cancerrecurrent adult primary liver cancerrecurrent childhood liver cancerrecurrent colon cancerstage IV colon cancerrecurrent rectal cancerstage IV rectal cancerrecurrent breast cancerstage IV breast cancerextensive stage small cell lung cancerrecurrent non-small cell lung cancerrecurrent small cell lung cancerstage IV non-small cell lung cancerrecurrent ovarian epithelial cancerrecurrent cervical cancerrecurrent adult soft tissue sarcomastage IV adult soft tissue sarcomachondrosarcomarecurrent osteosarcomapreviously treated childhood rhabdomyosarcomarecurrent childhood rhabdomyosarcomaovarian sarcomarecurrent uterine sarcomastage IV uterine sarcomastage I small lymphocytic lymphomacontiguous stage II small lymphocytic lymphomanoncontiguous stage II small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomaaccelerated phase chronic myelogenous leukemiablastic phase chronic myelogenous leukemiarecurrent childhood large cell lymphomastage I childhood large cell lymphomastage II childhood large cell lymphomastage III childhood large cell lymphomastage IV childhood large cell lymphomaadult primary hepatocellular carcinomaadvanced adult primary liver cancerovarian stromal cancerstage IA cervical cancerstage IB cervical cancerstage IIA cervical cancerstage IIB cervical cancerstage III cervical cancerstage IVA cervical cancerstage IVB cervical cancerrecurrent adult acute lymphoblastic leukemiauntreated adult acute lymphoblastic leukemiarecurrent childhood acute lymphoblastic leukemiauntreated childhood acute lymphoblastic leukemiarecurrent endometrial carcinomastage I endometrial carcinomastage II endometrial carcinomastage III endometrial carcinomastage IV endometrial carcinomachildhood hepatocellular carcinomastage III childhood liver cancerstage IV childhood liver cancerpreviously untreated childhood rhabdomyosarcomametastatic childhood soft tissue sarcomalocalized Ewing sarcoma/peripheral primitive neuroectodermal tumormetastatic Ewing sarcoma/peripheral primitive neuroectodermal tumorrecurrent Ewing sarcoma/peripheral primitive neuroectodermal tumorcontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomacontiguous stage II marginal zone lymphomanoncontiguous stage II marginal zone lymphomastage I marginal zone lymphomastage III marginal zone lymphomastage IV marginal zone lymphomalocalized osteosarcomametastatic osteosarcomastage I ovarian epithelial cancerstage II ovarian epithelial cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian germ cell tumorstage I ovarian germ cell tumorstage II ovarian germ cell tumorstage III ovarian germ cell tumorstage IV ovarian germ cell tumorlimited stage small cell lung cancerrefractory multiple myelomastage II malignant testicular germ cell tumorstage I adult soft tissue sarcomastage II adult soft tissue sarcomastage III adult soft tissue sarcomastage I bladder cancerstage II bladder cancerstage III bladder cancermale breast cancerstage I breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage I colon cancerstage II colon cancerstage III colon cancerstage I gastric cancerstage II gastric cancerstage III gastric cancerstage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage I pancreatic cancerstage II pancreatic cancerstage III pancreatic cancerstage I prostate cancerstage II prostate cancerstage III prostate cancerstage I rectal cancerstage II rectal cancerstage III rectal cancerstage I renal cell cancerstage II renal cell cancerstage III renal cell cancerstage I uterine sarcomastage II uterine sarcomastage III uterine sarcomastage I chronic lymphocytic leukemiastage II chronic lymphocytic leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiacontiguous stage II mantle cell lymphomanoncontiguous stage II mantle cell lymphomastage I mantle cell lymphomastage III mantle cell lymphomastage IV mantle cell lymphomaWaldenstrom macroglobulinemiacontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomastage I adult diffuse large cell lymphomastage III adult diffuse large cell lymphomastage IV adult diffuse large cell lymphomacontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult Burkitt lymphomastage I adult Burkitt lymphomastage III adult Burkitt lymphomastage IV adult Burkitt lymphomastage I mycosis fungoides/Sezary syndromestage II mycosis fungoides/Sezary syndromestage III mycosis fungoides/Sezary syndromestage IV mycosis fungoides/Sezary syndromeadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult acute myeloid leukemia with inv(16)(p13;q22)adult acute myeloid leukemia with t(15;17)(q22;q12)adult acute myeloid leukemia with t(16;16)(p13;q22)adult acute myeloid leukemia with t(8;21)(q22;q22)untreated adult acute myeloid leukemiauntreated childhood acute myeloid leukemia and other myeloid malignanciesde novo myelodysplastic syndromessecondary myelodysplastic syndromespreviously treated myelodysplastic syndromesnonmetastatic childhood soft tissue sarcomarecurrent childhood soft tissue sarcomastage I childhood Hodgkin lymphomastage II childhood Hodgkin lymphomastage III childhood Hodgkin lymphomastage IV childhood Hodgkin lymphomastage I adult Hodgkin lymphomastage II adult Hodgkin lymphomastage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent childhood small noncleaved cell lymphomastage I childhood small noncleaved cell lymphomastage II childhood small noncleaved cell lymphomastage III childhood small noncleaved cell lymphomastage IV childhood small noncleaved cell lymphomaBurkitt lymphomastage I adult T-cell leukemia/lymphomastage II adult T-cell leukemia/lymphomastage III adult T-cell leukemia/lymphomastage IV adult T-cell leukemia/lymphomastage I malignant testicular germ cell tumorchildhood myelodysplastic syndromeschildhood renal cell carcinomastage IA melanomastage IB melanomastage IIA melanomastage IIB melanomastage IIC melanomastage IIIA melanomastage IIIB melanomastage IIIC melanomastage IV melanomarecurrent melanoma

Outcome Measures

Primary Outcomes (1)

  • Toxicity

    10 years

Secondary Outcomes (2)

  • Response

    10 years

  • Presence of disease or antigen-specific lymphocytes

    10 years

Study Arms (1)

Treatment

EXPERIMENTAL

Biological/Vaccine: therapeutic allogeneic lymphocytes The total CD3+ cell dose target is 1.8 x 108 CD3+ cells/kg +/- 1.0 x 108 CD3+ cells/kg. Up to 6 cycles.

Biological: therapeutic allogeneic lymphocytes

Interventions

therapeutic allogeneic lymphocytesBIOLOGICAL

The total CD3+ cell dose target is 1.8 x 108 CD3+ cells/kg +/- 1.0 x 108 CD3+ cells/kg. Up to 6 cycles.

Treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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: * Relapsed within 1 year after prior fludarabine phosphate-containing regimens OR not a candidate to receive such therapy due to comorbidities or allergies * Received prior anti-CD52 monoclonal antibody therapy OR ineligible to receive such therapy (for patients without symptomatic lymphadenopathy) * Has documentation of disease-associated symptoms, rapid progression of disease, or other indications for treatment * B- or T-cell prolymphocytic leukemia meeting any of the following criteria: * Relapsed within 1 year after prior fludarabine phosphate- or alkylating agent-containing regimens OR not a candidate to receive such therapy due to comorbidities or allergies * Relapsed within 1 year after prior anti-CD20 monoclonal antibody therapy OR ineligible to receive such therapy (for patients with CD20-positive disease) * Received prior anti-CD52 monoclonal antibody therapy OR ineligible to receive such therapy (for patients without symptomatic lymphadenopathy) * Lymphoplasmacytic lymphoma, marginal zone lymphoma, mucosa-associated lymphoid tissue lymphoma, or follicular lymphoma meeting any of the following criteria: * Relapsed within 1 year after prior fludarabine phosphate- or alkylating agent-containing regimens or radioconjugated anti-CD20 monoclonal antibody OR not a candidate to receive such therapy due to comorbidities or allergies * Relapsed within 1 year after prior anti-CD20 monoclonal antibody therapy OR ineligible to receive such therapy (for patients with CD20-positive disease) * Has documentation of disease-associated symptoms, rapid progression of disease, or other indications for treatment * Multiple myeloma meeting any of the following criteria: * Relapsed after prior alkylating agents, thalidomide, corticosteroids, or bortezomib OR not a candidate to receive such therapy due to comorbidities or allergies * Relapsed after prior high-dose chemotherapy followed by autologous hematopoietic stem cell rescue OR not a candidate to receive such therapy * Mantle cell lymphoma that has relapsed after prior combination chemotherapy or anti-CD20 monoclonal antibody OR not a candidate to receive such therapy * Diffuse large B-cell lymphoma meeting any of the following criteria: * Relapsed after prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue OR not a candidate to receive such therapy * Received prior radiolabeled anti-CD20 monoclonal antibody OR ineligible to receive such therapy (for patients with transformed large cell lymphoma) * Burkitt's lymphoma * Relapsed after prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue OR not a candidate for such therapy * Lymphomatoid granulomatosis or mature T-cell or NK-cell neoplasms meeting any of the following criteria: * Relapsed after prior single agent or combination chemotherapy OR not a candidate to receive such therapy * Has documentation of disease-associated symptoms, rapid progression of disease, or other indications for treatment * Mycosis fungoides or Sezary syndrome * Relapsed after prior combination chemotherapy, interferon-α, denileukin diftitox, or extracorporeal photophoresis OR not a candidate to receive such therapy * Anaplastic large cell lymphoma, peripheral T-cell lymphoma unspecified, or angioimmunoblastic T-cell lymphoma meeting the following criteria: * Relapsed after prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue OR not a candidate to receive such therapy * Hepatosplenic T-cell lymphoma or adult T-cell leukemia/lymphoma * Relapsed after prior salvage combination chemotherapy OR not a candidate to receive such therapy * Hodgkin's lymphoma * Relapsed after prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue OR not a candidate to receive such therapy * Acute lymphocytic leukemia meeting any of the following criteria: * Relapsed during or after prior multi-agent combination chemotherapy administered in sequential induction, consolidation, and maintenance courses OR not a candidate to receive such therapy * Relapsed after prior salvage combination chemotherapy with or without high-dose chemotherapy followed by autologous hematopoietic stem cell rescue OR not a candidate to receive such therapy * Relapsed after prior chemotherapy with or without radiotherapy followed by allogeneic hematopoietic stem cell transplant (or ineligible for such therapy) AND demonstrates persistent cytogenetic, fluorescent in situ hybridization (FISH), or molecular (reverse transcriptase-polymerase chain reaction) evidence of bcr-abl fusion gene despite 6 weeks of treatment with imatinib mesylate * Acute myelogenous leukemia or myelodysplasia meeting any of the following criteria: * Relapsed or refractory disease after prior induction chemotherapy (anthracycline and cytarabine, topotecan hydrochloride and cytarabine, or comparable regimen) OR not a candidate to receive such therapy * Not a candidate for chemotherapy with or without radiotherapy followed by allogeneic or autologous hematopoietic stem cell transplant * Patients with acute promyelomonocytic leukemia must have received prior tretinoin and arsenic trioxide * Chronic myelogenous leukemia meeting any of the following criteria: * Relapsed or refractory disease after prior imatinib mesylate * Not a candidate for chemotherapy with or without radiotherapy followed by allogeneic hematopoietic stem cell transplant * Chronic phase disease allowed if there is FISH or cytogenetic evidence of increasing disease * Solid tumor, including any of the following: * Renal cell carcinoma * Metastatic relapsed or refractory disease after prior high-dose aldesleukin OR ineligible to receive such therapy due to comorbidities OR did not consent to treatment * Bladder cancer or gastric cancer * Metastatic relapsed or refractory disease after prior combination therapy OR not a candidate to receive such therapy * Prostate cancer * Metastatic relapsed or refractory disease after prior hormonal therapy OR not a candidate to receive such therapy * Testicular cancer * Metastatic relapsed or refractory disease after prior standard induction or salvage chemotherapy or high-dose chemotherapy with autologous hematopoietic stem cell rescue OR not a candidate to receive such therapy * Pancreatic cancer * Metastatic relapsed or refractory disease after prior gemcitabine hydrochloride-based therapy OR not a candidate to receive such therapy * Hepatocellular carcinoma * Unresectable or metastatic disease * Colorectal carcinoma * Metastatic relapsed or refractory disease after prior combination therapy, including fluorouracil with or without leucovorin calcium, oxaliplatin, or irinotecan hydrochloride OR not a candidate to receive such therapy * Breast cancer meeting any of the following criteria: * Metastatic relapsed or refractory disease after prior first- or second-line standard combination chemotherapy OR not a candidate to receive such therapy * Received prior trastuzumab (Herceptin®) and sequential hormonal therapy OR not a candidate to receive such therapy as indicated by the biological characteristics of the cancer * Lung cancer (non-small cell or small cell lung cancer), ovarian cancer, endometrial cancer, or cervical cancer * Metastatic relapsed or refractory disease after prior first- or second-line combination chemotherapy OR not a candidate to receive such therapy * Malignant melanoma * Metastatic relapsed or refractory disease after prior immunotherapy or combination chemotherapy OR not a candidate to receive such therapy * Sarcoma meeting any of the following criteria: * Metastatic relapsed or refractory disease after prior first- or second-line combination chemotherapy OR not a candidate to receive such therapy * Not a candidate for resection * Patients with gastrointestinal stromal tumors must have received prior imatinib mesylate * Measurable disease * Must have received prior available standard therapy for specific disease OR not a candidate for this treatment * No CNS malignancy * HLA-partially matched (≥ 2/6 HLA antigen \[A, B, DR\]) related donor (above 18 years of age) available PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy \> 3 months * Bilirubin \< 1.5 times upper limit of normal (ULN) * AST \< 3.0 times ULN * LVEF \> 35% * No active infections * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No uncontrolled medical or psychiatric illness that would preclude study compliance, in the opinion of the investigator PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

NeoplasmsLeukemia, Lymphocytic, Chronic, B-CellLeukemia, ProlymphocyticLymphoma, B-Cell, Marginal ZoneLymphoma, FollicularMultiple MyelomaLymphoma, Mantle-CellLymphoma, Large B-Cell, DiffuseBurkitt LymphomaLymphoma, Extranodal NK-T-CellMycosis FungoidesSezary SyndromeLymphoma, Large-Cell, AnaplasticImmunoblastic LymphadenopathyPrecursor T-Cell Lymphoblastic Leukemia-LymphomaHodgkin DiseaseRecurrenceLeukemia, Myeloid, AcuteLeukemia, Myeloid, Chronic-PhaseCarcinoma, Renal CellUrinary Bladder NeoplasmsProstatic NeoplasmsTesticular NeoplasmsStomach NeoplasmsPancreatic NeoplasmsCarcinoma, HepatocellularColonic NeoplasmsRectal NeoplasmsBreast NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaCarcinoma, Ovarian EpithelialUterine Cervical NeoplasmsSarcomaChondrosarcomaOsteosarcomaLeukemia, Myeloid, Accelerated PhaseBlast CrisisDendritic Cell Sarcoma, InterdigitatingPrecursor Cell Lymphoblastic Leukemia-LymphomaEndometrial NeoplasmsNeuroectodermal Tumors, Primitive, PeripheralBreast Neoplasms, MaleWaldenstrom MacroglobulinemiaCongenital AbnormalitiesMelanoma

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLymphoma, B-CellLymphoma, Non-HodgkinLymphomaNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, T-CellLymphoma, T-Cell, CutaneousLymphadenopathyLeukemia, MyeloidLeukemia, Myelogenous, Chronic, BCR-ABL PositiveMyeloproliferative DisordersBone Marrow DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesUrinary Bladder DiseasesGenital Neoplasms, MaleGenital Diseases, MaleGenital DiseasesProstatic DiseasesEndocrine Gland NeoplasmsEndocrine System DiseasesTesticular DiseasesGonadal DisordersGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesPancreatic DiseasesLiver NeoplasmsLiver DiseasesColorectal NeoplasmsIntestinal NeoplasmsColonic DiseasesIntestinal DiseasesRectal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesOvarian NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleGenital Neoplasms, FemaleUterine NeoplasmsUterine Cervical DiseasesUterine DiseasesNeoplasms, Connective and Soft TissueNeoplasms, Connective TissueNeoplasms, Bone TissueCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesHistiocytic Disorders, MalignantHistiocytosisNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeuroendocrine TumorsNevi and MelanomasSkin Neoplasms

Study Officials

  • Roger Strair, MD, PhD

    Rutgers Cancer Institute of New Jersey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

May 1, 2001

Primary Completion

October 1, 2010

Study Completion

October 1, 2011

Last Updated

November 6, 2015

Record last verified: 2013-09

Locations

US(1)