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Phase I Trial of MEDI-507 in CD2-Positive Lymphoproliferative Disease

Phase 1
18 Years
Not Enrolling
Lymphoproliferative Disorders

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Trial Information

Phase I Trial of MEDI-507 in CD2-Positive Lymphoproliferative Disease

Inclusion Criteria:

- Men or women at least 18 years of age. Women of childbearing potential must have a
negative serum pregnancy test within 5 days of the initial MEDI-507 administration
and a negative urine pregnancy test on Day 0 prior to receiving the first dose of
MEDI-507. Women of childbearing potential must agree to practice an effective method
of contraception. Sexually active males must agree to use a condom.

- Histologically confirmed diagnosis of a lymphoproliferative disorder as determined by
the Laboratory of Pathology at the Clinical Center at the National Institutes of
Health (NIH). Only patients with the following lymphoproliferative disorders will be

- ATL: Patients with all except the smoldering form of adult T-cell
leukemia/lymphoma (ATL) will be eligible, regardless of whether they have had
previous therapy, since there is no effective standard of care therapy for this

- CTCL: Patients with all stages of cutaneous T-cell lymphoma (CTCL) are eligible
with the exception of Stage Ia. Patients with Stages Ib through III are eligible
if their disease has failed at least one standard form of prior therapy;

- PTCL: Patients with Stages I-IV peripheral T-cell lymphoma (PTCL) are eligible
if their disease has progressed after standard chemotherapy;

- LGL: Patients with large granular lymphocyte leukemia (LGL) must have
myelosuppression (granulocyte count ≤1,500/uL; platelet count ≤75,000/uL; or
hemoglobin ≤10 g/dL), or require hematopoietic support (transfusion or colony
stimulating factors including filgrastim, IL-11, or erythropoietin) to maintain
counts at these or higher levels or systemic symptoms (fever, night sweats or
weight loss). Patients must have disease that is unresponsive to one prior
therapy. Patients with monoclonal and polyclonal forms of the disease will be

- Cells must express CD2. CD2 expression will be verified by immunohistochemistry in
the Laboratory of Pathology at the NIH. At least 30% of tumor cells must be CD2
positive for the patient to be eligible for the study by immunohistochemistry. CD2
staining will be performed on existing tissue blocks and on fresh tumor tissue if a
biopsy is performed. It is expected that the majority of patients will have CD2
expression evaluated by flow cytometry and the majority of cells will express the

- Measurable or evaluable disease.

- Karnofsky Performance Status ≥70%.

- Life expectancy of >2 months.

- Granulocyte count ≥1,000/mm3 and a platelet count ≥50,000/mm3. Patients with LGL
leukemia are excluded from these criteria. For patients with LGL leukemia, ANC and
platelet count will not be considered in determining study eligibility.

- Serum creatinine <1.5 mg/dL.

- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate
transaminase (SGPT) value ≤2.0-fold greater than the upper limit of normal (if due to
lymphoma in the liver, patients will be allowed to have transaminase values ≤ 5.0
fold greater than the upper limit of normal) and bilirubin ≤2.0 mg/dL unless due to
Gilbert's syndrome (unconjugated hyperbilirubinemia) in which case the bilirubin
should be ≤3.5 mg/dL.

- Prior treatment with cytotoxic chemotherapy, surgery, and prolonged cytolytic steroid
therapy is allowed provided last treatment was given at least 3 weeks prior to first
dose of study drug administration and all toxicities have resolved.

- Prior treatment with other investigational anticancer drugs and monoclonal antibodies
is allowed provided the last treatment was given at least 30 days prior to the first
dose of study drug administration.

- Patients must understand and sign a National Cancer Institute (NCI) pre-screening
consent form and a protocol specific informed consent form prior to receipt of any
study medication or beginning study procedures.

Exclusion Criteria:

- Known history of central nervous system (CNS) disease.

- Pregnant or nursing. The effects of MEDI-507 on the developing fetus and the nursing
infant are unknown.

- Positive for human immunodeficiency virus (HIV) because of the risk of increased
HIV-associated complications due to increased immunosuppression.

- Positive for hepatitis B surface antigen or with antibodies to hepatitis C virus
because the therapy may be associated with increased viral replication.

- Symptomatic CMV positivity or CMV PCR >1000 copies

- Prior treatment with MEDI-507.

- Prior history of significant adverse events related to previously administered
monoclonal antibody.

- History within 6 months prior to first dose of study drug administration or evidence
of intercurrent illnesses including myocardial infarction, uncontrolled hypertension,
stroke, or transient ischemic attacks.

- Respiratory insufficiency requiring oxygen therapy or O2 saturation less than 90% by
pulse oximetry.

- Active infection requiring systemic anti-infective therapy or other physical or
psychological illnesses that would increase risk to the patient, in the opinion of
the Principal Investigator.

- Any general medical or psychological or behavioral conditions that, in the opinion of
the investigator, may pose additional risk in administering study drug to the patient
or will not permit the patient to complete the study or sign informed consent.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose (MTD) or the optimal biological dose

Principal Investigator

John Janik, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Food and Drug Administration

Study ID:




Start Date:

April 2004

Completion Date:

Related Keywords:

  • Lymphoproliferative Disorders
  • CD2+ Lymphoproliferative disorder
  • Lymphoproliferative Disorders



National Cancer Institute/National Institutes of Health Bethesda, Maryland  20892