- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00161187
Irradiated Donor Lymphocyte Infusion in Treating Patients With Relapsed or Refractory Hematologic Cancer or Solid Tumor
A Pilot Study of Irradiated HLA-Partially Matched Allogeneic Related Donor Lymphocytes for Patients With Selected Malignancies
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Determine the toxicity of irradiated allogeneic donor lymphocyte infusion in patients with relapsed or refractory hematological cancer or solid tumor.
- Determine the response in patients treated with this regimen.
- Determine the presence of disease or antigen-specific lymphocytes in patients treated with this regimen.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Toxicity
Time Frame: 10 years
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response
Time Frame: 10 years
|
10 years
|
Presence of disease or antigen-specific lymphocytes
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage IV renal cell cancer
- recurrent renal cell cancer
- stage II malignant testicular germ cell tumor
- stage III malignant testicular germ cell tumor
- stage IV breast cancer
- stage IIIA breast cancer
- recurrent breast cancer
- stage IIIB breast cancer
- recurrent non-small cell lung cancer
- extensive stage small cell lung cancer
- recurrent small cell lung cancer
- stage III bladder cancer
- recurrent bladder cancer
- stage IV bladder cancer
- stage III prostate cancer
- stage IV prostate cancer
- recurrent prostate cancer
- stage IIIA non-small cell lung cancer
- stage IIIB non-small cell lung cancer
- stage IV non-small cell lung cancer
- stage IV rectal cancer
- stage IV colon cancer
- recurrent colon cancer
- recurrent rectal cancer
- stage I mycosis fungoides/Sezary syndrome
- stage I chronic lymphocytic leukemia
- recurrent pancreatic cancer
- stage I non-small cell lung cancer
- stage II non-small cell lung cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- recurrent ovarian epithelial cancer
- stage III colon cancer
- male breast cancer
- stage II breast cancer
- stage IIIC breast cancer
- chondrosarcoma
- stage I breast cancer
- stage III adult diffuse large cell lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult Burkitt lymphoma
- stage III childhood small noncleaved cell lymphoma
- stage IV childhood small noncleaved cell lymphoma
- stage IV childhood large cell lymphoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- recurrent melanoma
- stage IV melanoma
- stage IIIA melanoma
- stage IIIB melanoma
- stage IIIC melanoma
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- adult 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)
- chronic phase chronic myelogenous leukemia
- childhood chronic myelogenous leukemia
- childhood myelodysplastic syndromes
- recurrent adult acute myeloid leukemia
- untreated adult acute myeloid leukemia
- limited stage small cell lung cancer
- untreated childhood acute lymphoblastic leukemia
- stage IV pancreatic cancer
- recurrent adult Hodgkin lymphoma
- recurrent/refractory childhood Hodgkin lymphoma
- blastic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- Waldenstrom macroglobulinemia
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- stage II multiple myeloma
- stage III multiple myeloma
- stage I grade 1 follicular lymphoma
- stage I grade 2 follicular lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- noncontiguous stage II marginal zone lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage I marginal zone lymphoma
- stage I small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- contiguous stage II marginal zone lymphoma
- contiguous stage II small lymphocytic lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- stage IV gastric cancer
- recurrent gastric cancer
- advanced adult primary liver cancer
- recurrent adult primary liver cancer
- stage IV endometrial carcinoma
- recurrent endometrial carcinoma
- stage I multiple myeloma
- recurrent mantle cell lymphoma
- stage I bladder cancer
- refractory chronic lymphocytic leukemia
- stage II chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- stage I renal cell cancer
- stage III renal cell cancer
- childhood renal cell carcinoma
- stage I prostate cancer
- localized osteosarcoma
- previously treated childhood rhabdomyosarcoma
- recurrent childhood rhabdomyosarcoma
- stage IIB cervical cancer
- stage III cervical cancer
- stage IVA cervical cancer
- stage IB cervical cancer
- stage IIA cervical cancer
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- adult nasal type extranodal NK/T-cell lymphoma
- recurrent adult grade III lymphomatoid granulomatosis
- stage II prostate cancer
- stage III gastric cancer
- refractory multiple myeloma
- recurrent adult acute lymphoblastic leukemia
- prolymphocytic leukemia
- stage IV adult soft tissue sarcoma
- recurrent adult soft tissue sarcoma
- stage IV uterine sarcoma
- recurrent uterine sarcoma
- ovarian sarcoma
- recurrent childhood acute lymphoblastic leukemia
- stage I childhood large cell lymphoma
- stage II childhood large cell lymphoma
- stage III childhood large cell lymphoma
- stage I childhood small noncleaved cell lymphoma
- stage II childhood small noncleaved cell lymphoma
- stage I ovarian epithelial cancer
- stage II ovarian epithelial cancer
- contiguous stage II mantle cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- accelerated phase chronic myelogenous leukemia
- recurrent cervical cancer
- stage IA cervical cancer
- stage IVB cervical cancer
- stage I uterine sarcoma
- stage II uterine sarcoma
- stage III uterine sarcoma
- ovarian stromal cancer
- recurrent ovarian germ cell tumor
- stage I ovarian germ cell tumor
- stage II ovarian germ cell tumor
- stage III ovarian germ cell tumor
- stage IV ovarian germ cell tumor
- stage II rectal cancer
- stage III rectal cancer
- stage II colon cancer
- stage IV childhood Hodgkin lymphoma
- recurrent childhood acute myeloid leukemia
- noncontiguous stage II adult Burkitt lymphoma
- stage III childhood Hodgkin lymphoma
- stage III pancreatic cancer
- recurrent malignant testicular germ cell tumor
- stage III endometrial carcinoma
- localized unresectable adult primary liver cancer
- metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor
- recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor
- metastatic osteosarcoma
- recurrent osteosarcoma
- stage III adult soft tissue sarcoma
- stage I mantle cell lymphoma
- stage I rectal cancer
- stage I adult Hodgkin lymphoma
- stage II adult Hodgkin lymphoma
- stage I gastric cancer
- stage II gastric cancer
- stage I adult Burkitt lymphoma
- contiguous stage II adult Burkitt lymphoma
- stage I childhood Hodgkin lymphoma
- stage II childhood Hodgkin lymphoma
- stage I pancreatic cancer
- stage II pancreatic cancer
- stage II bladder cancer
- stage II adult soft tissue sarcoma
- untreated adult acute lymphoblastic leukemia
- stage I colon cancer
- childhood diffuse large cell lymphoma
- recurrent childhood grade III lymphomatoid granulomatosis
- adult primary hepatocellular carcinoma
- stage II renal cell cancer
- stage IV childhood liver cancer
- recurrent childhood liver cancer
- metastatic childhood soft tissue sarcoma
- recurrent childhood soft tissue sarcoma
- contiguous stage II grade 3 follicular lymphoma
- stage I grade 3 follicular lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- stage I adult diffuse large cell lymphoma
- stage II mycosis fungoides/Sezary syndrome
- stage I adult T-cell leukemia/lymphoma
- stage II adult T-cell leukemia/lymphoma
- untreated childhood acute myeloid leukemia and other myeloid malignancies
- Burkitt lymphoma
- childhood nasal type extranodal NK/T-cell lymphoma
- stage I adult soft tissue sarcoma
- previously untreated childhood rhabdomyosarcoma
- nonmetastatic childhood soft tissue sarcoma
- stage II endometrial carcinoma
- stage I endometrial carcinoma
- stage IB melanoma
- localized Ewing sarcoma/peripheral primitive neuroectodermal tumor
- childhood hepatocellular carcinoma
- stage III childhood liver cancer
- stage IA melanoma
- stage IIA melanoma
- stage IIB melanoma
- stage IIC melanoma
- stage I malignant testicular germ cell tumor
Other Study ID Numbers
- 010101
- P30CA072720 (U.S. NIH Grant/Contract)
- 0220003330 (Other Identifier: CINJ IRB)
- CDR0000540298 (Other Identifier: NIH)
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