Breast Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

37

Study ID:

NCT00161187

Recruitment Status:

Completed

Sponsor:

University of Medicine and Dentistry of New Jersey

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Study is for people with:

Breast Cancer

Phase:

Phase 1

Estimated Enrollment:

37

Study ID:

NCT00161187

Recruitment Status:

Completed

Sponsor:


University of Medicine and Dentistry of New Jersey

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