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AzTrials

CancerPhase 1NCT00161187

Irradiated Donor Lymphocyte Infusion in Treating Patients With Relapsed or Refractory Hematologic Cancer or Solid Tumor

A Phase 1 study testing therapeutic allogeneic lymphocytes in people with Cancer, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any age
Conditions the study is for
Cancer
What is being tested?
therapeutic allogeneic lymphocytes
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
May 2001to Oct 2011
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
Cancer
Being tested
therapeutic allogeneic lymphocytes
Keywords
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
Medical subject headings
Neoplasms, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, Prolymphocytic, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Follicular, Multiple Myeloma, Lymphoma, Mantle-Cell, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT00161187
Study groupRoleWhat they receive
TreatmentExperimentalBiological/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.
Receives: Biological: therapeutic allogeneic lymphocytes

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Toxicity

    Measured: 10 years

Secondary outcomes (2)
  1. Response

    Measured: 10 years

  2. Presence of disease or antigen-specific lymphocytes

    Measured: 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startMay 2001
  3. Primary completionOct 2010
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00161187
Sponsor's protocol ID
010101
Other IDs
P30CA072720, 0220003330, CDR0000540298
Status last verified
Sep 2013
First submitted
8 Sep 2005
Last updated
6 Nov 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing therapeutic allogeneic lymphocytes in people with Cancer, run by University of Medicine and Dentistry of New Jersey at 1 site in United States.

The full registered description is in the About this study section and the official record.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Toxicity (time frame: 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2015.

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