Irradiated Donor Lymphocyte Infusion in Treating Patients With Relapsed or Refractory Hematologic Cancer or Solid Tumor
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Purpose
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 |
Biological: therapeutic allogeneic lymphocytes |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Irradiated HLA-Partially Matched Allogeneic Related Donor Lymphocytes for Patients With Selected Malignancies |
- Toxicity [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]
- Response [ Time Frame: 10 years ] [ Designated as safety issue: No ]
- Presence of disease or antigen-specific lymphocytes [ Time Frame: 10 years ] [ Designated as safety issue: No ]
| Enrollment: | 37 |
| Study Start Date: | May 2001 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
-
Biological: therapeutic allogeneic lymphocytes
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.
Eligibility| 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:
- 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
Contacts and Locations| United States, New Jersey | |
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | |
| New Brunswick, New Jersey, United States, 08903 | |
| Principal Investigator: | Roger Strair, MD, PhD | Cancer Institute of New Jersey |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Medicine and Dentistry New Jersey |
| ClinicalTrials.gov Identifier: | NCT00161187 History of Changes |
| Other Study ID Numbers: | 010101, P30CA072720, 0220003330, CDR0000540298 |
| Study First Received: | September 8, 2005 |
| Last Updated: | June 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Medicine and Dentistry New Jersey:
|
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 |
Additional relevant MeSH terms:
|
Lymphoma, Non-Hodgkin Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases |
Immunoproliferative Disorders Immune System Diseases Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 22, 2013