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Clinical Trial 18744

Cancer Type:
Interventions:MEDI-570

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • Julio Chavez

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase I Trial of MEDI-570 in Patients with Relapsed/Refractory Peripheral T-Cell Lymphoma (PTCL) Follicular Variant and Angioimmunoblastic T-Cell Lymphoma (AITL)

Summary

The purpose of this study is to test the safety of MEDI-570 at different doses to find out what effects, if any, it has on people. This drug has been tested in people for treatment of an autoimmune disease, given by subcutaneous (under the skin) injections. There will be about 4 to 46 people taking part in this study. Another purpose of this study is for researchers to learn if a biomarker test is helpful or not to decide if MEDI-570 has clinical activity in lymphomas that have the ICOS protein.

Objective

Primary Objectives: To determine the safety, maximum tolerated dose and recommended phase II dose (RP2D) of MEDI-570 in patients with refractory/relapsed peripheral T-cell lymphoma (PTCL) follicular variant and angioimmunoblastic T-cell lymphoma (AITL).

Inclusion Criteria

  • PATHOLOGIC DIAGNOSIS OF ONE OF THE FOLLOWIING: DOSE ESCALATION: 1.) Confirmed diagnosis of peripheral T-cell lymphoma (PTCL) or angioimmunoblastic T-cell lymphoma (AITL) that is refractory to at least one line of therapy; anaplastic large cell lymphoma (ALCL) and natural killer T-cell lymphoma nasal type (NKTCL) are excluded. 2.) Advanced stage cutaneous T-cell lymphoma (CTCL), specifically CTCL NOS, small/medium T-cell lymphoma (SMTCL) and mycosis fungoides (MF) stage IB, IIA, IIB, III and IV that have relapsed after at least one specific prior therapy (e.g. interferon, photopheresis, denileukin difitox, bexarotene, etc); anaplastic cutaneous large cell lymphoma (ACLCL) and lymphomatoid papulopsis are excluded. 3.) Follicular lymphoma grade 1, 2 or 3A that meets the following criteria: a.) Relapsed or refractory to at least 2 lines of therapy AND, b.) Relapsed or refractory post autologous cell transplantation (HCT). DOSE EXPANSION/DOSE CONFIRMATION: Patients with confirmed diagnosis of peripheral T-cell lymphoma (PTCL) follicular type or angioimmunoblastic T-cell lymphoma (AITL) that is refractory to at least one line of therapy. OVERALL STUDY:
  • At least 14 days from the last therapy dose or 5 half-lives (whichever is shorter), 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 at least one measurable lesion that can be accurately measured with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI) scan, or physical exam (by calipers only); (PTCL, AITL and follicular lymphoma patients will be assessed on this study using the Lugano criteria for the evaluation of lymphomas; CTCL and MF patients will be assessed using International Society for Cutaneous Lymphomas [ISCL] and European Organization for Research and Treatment of Cancer [EORTC criteria]).
  • Eastern Cooperative Oncology Group (ECOG) performance status equal to or less than 2 (Karnofsky >= 60%)
  • Life expectancy of greater than 6 months
  • Adequate hematologic, hepatic and renal function
  • 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 prior to study entry, during the study participation, and for 3 months after the last dose of the drug
  • Ability to understand and the willingness to sign a written informed consent document

  • Exclusion Criteria

  • Have had chemotherapy or other systemic anticancer treatments within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Have had radiation therapy within 2 weeks prior to entering the study
  • Potential participants who are receiving any other investigational agents
  • Known brain metastases
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to MEDI-570
  • 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 infection at any time with hepatitis B or C virus or human immunodeficiency virus (HIV)-1 or HIV-2; patients will be tested at the time of screening
  • History of primary immunodeficiency
  • Evidence of active or latent tuberculosis (TB)
  • Have undergone allogeneic stem cell transplantation
  • Have undergone autologous stem cell transplantation within 3 months from study entry
  • 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
  • Women who are pregnant or breastfeeding
  • HIV-positive, on combination antiretroviral therapy