Study of Experimental medicine, Anti-ICOS Monoclonal Antibody MEDI-570, in the treatment of Non-Hodgkin's Lymphoma

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"Immunotherapy (Anti-ICOS Monoclonal Antibody MEDI-570) study of side effects, best dose, and helpfulness in treatment of Lymphoma"
Age:
18 to 100 years old
Gender:
Any
Healthy Volunteers:
No
Keywords:
Non-Hodgkin's Lymphoma, cancer, Immunotherapy
Type:
Biological study, Phase 1
Investigator:
Description
The purpose of this study is to test the safety of experimental MEDI-570 at different doses to study side effects, best dose, and helpfulness in treatment. Monoclonal antibodies, such as anti-ICOS monoclonal antibody MEDI-570, may block cancer growth in different ways by targeting certain cells. MEDI-570 has been tested in people for treatment of an autoimmune disease, given by subcutaneous (under the skin) injections. Another purpose of this study is for researchers to learn if a biomarker test is helpful. The US Food and Drug Administration and Health Canada have not approved MEDI-570 for use in cancer
This study requires
Blood & urine tests
Electrocardiogram (ECG)
Tumor sample from past surgery/biopsy or new research biopsy
CT/MRI scan every two cycles
PET scan at end of study treatment
IV- administration MEDI-570
Who can participate?
Inclusion Criteria:

- Patients must have histologically or pathologically confirmed diagnosis of peripheral T-cell lymphoma (PTCL) follicular variant or angioimmunoblastic T-cell lymphoma (AITL) as per World Health Organization (WHO) 2008 criteria

- At least 28 days from the last therapy dose, and resolution of toxicity related to the last therapy, excluding grade 2 or less peripheral neuropathy and alopecia; for radiation therapy, a minimum of 2 weeks and resolution of all acute toxicity will be required

- Must have refractory/relapsed disease to at least one line of therapy

- Patients must have at least one measurable lesion that can be accurately with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI) scan, or physical exam (by calipers only); patients will be assessed on this study using the Lugano criteria for the evaluation of lymphomas

- Eastern Cooperative Oncology Group (ECOG) performance status == 60%)

- Life expectancy of greater than 6 months

- Leukocytes >= 3,000/mcL

- Hemoglobin >= 90 d/L (or >= 9g/dL)

- Absolute neutrophil count >= 1,500/mcL

- Platelets >= 75,000/mcL

- Absolute CD4 count > 200 cells/uL

- Total bilirubin < 1.5 upper limit of normal (ULN)

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =< 2.5 x institutional upper limit of normal

- Creatinine < 1.5 mg/dl (= 132 umol/L) or

- Creatinine clearance >= 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

- Availability of tissue for correlative studies; patients must have at least 6-8 unstained slides of archived formalin-fixed, paraffin-embedded tumor tissue available; if not enough archived tissue is available, a fresh tumor biopsy prior to study initiation is mandatory; for patients who have undergone a fresh baseline biopsy at baseline, the archived tissue is not mandatory

- Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, during the study participation, and for 3 months after the last dose of the drug; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; men treated or enrolled on this protocol must have either had a prior vasectomy or agree to use effective contraception prior to the study, during the study, and for 3 months after the last dose of the drug; males should avoid fathering children during and for at least three months after therapy is completed

- Ability to understand and the willingness to sign a written informed consent document


Exclusion Criteria:

- Patients who are receiving any other investigational agents

- Patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events

- History of allergic reactions attributed to compounds of similar chemical or biologic composition to MEDI-570 or history of anaphylaxis to any biological component

- Any history or evidence of opportunistic infection within 6 months of screening including tuberculosis, severe cytomegalovirus (CMV) or herpetic infections (such as disseminated herpes, herpes encephalitis, ophthalmic herpes)

- Evidence of active infection by hepatitis B and/or C; for patients with hepatitis B treated with anti-virals to undetectable viral load, and for patients with hepatitis C with undetectable ribonucleic acid (RNA) levels and no evidence of liver damage, enrollment may be considered and should discuss first with study's principal investigator

- History of human immunodeficiency virus (HIV) infection

- History of primary immunodeficiency

- Receipt of live or live attenuated vaccine within 12 weeks prior to enrollment

- All potential patients must undergo a tuberculosis (TB) test prior to study entry (either purified protein derivative [PPD] or QuantiFERON-TB Gold, whichever is preferred and available at the Institution); patients with a history of TB (even if treated), or evidence of active or latent TB, are excluded; the diagnosis of active TB is defined per current guidelines; patients with a positive TB test (e.g. PPD or QuantiFERON-TB Gold) will be excluded; patients with history of Bacille-Calmette-Guerin (BCG) vaccination will be tested with QuantiFERON-TB Gold test in order to rule out exposure to TB

- Patients who have undergone allogeneic stem cell transplantation

- Patients who have undergone autologous stem cell transplantation within 3 months from study entry

- Major surgery within 30 days prior or during the study period

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

- Pregnant women are excluded from this study; breastfeeding should be discontinued if the mother is treated with MEDI-570

- Patients with active, known, or suspected autoimmune disease

- Participants with well-controlled asthma and/or mild allergic rhinitis (seasonal allergies) are eligible

- Participants with the following disease conditions are also eligible:

- Vitiligo,

- Type 1 diabetes mellitus

- Residual hypothyroidism due to autoimmune condition only requiring hormone replacement

- Euthyroid participants with a history of Grave's disease (participants suspected autoimmune thyroid disorders must be negative for thyroglobulin and thyroid peroxidase antibodies and thyroid stimulating immunoglobulin prior to first dose of study drug)

- For patients with ITP (idiopathic thrombocytopenic purpura) or AIHA (autoimmune hemolytic anemia), a case by case discussion with study principal investigator (PI) may be considered

- Patients with a weight of < 39 kg
Resources
Schedule
Study duration and period
Variable. The study drug is given once every 3 weeks (cycle), up to 12 cycles (9 weeks) and then follow up at 6 weeks and 12 weeks after cycles complete
Recruitment period
From Feb. 16, 2017
Location
UC Davis Comprehensive Cancer Center
2279 45th Street
Sacramento, CA 95817
Contact
Christina Romo
Research Topic
Conditions:
  • Follicular Variant Peripheral T-Cell Lymphoma
  • Recurrent Angioimmunoblastic T-cell Lymphoma
  • Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma
  • Refractory Angioimmunoblastic T-cell Lymphoma
  • Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma

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