Phase I Study of MEDI-507 to Treat Lymphoproliferative Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00071825
• Date of registration: 31/10/2003
• Primary sponsor: National Cancer Institute (NCI)
• Public title: Phase I Study of MEDI-507 to Treat Lymphoproliferative Disease
• Scientific title: Phase I Trial of Medi-507 in CD2-Positive Lymphoproliferative Disease
• Date of first enrolment: October 2003
• Target sample size: 29
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00071825
• Study type: Interventional
• Study design: Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Thomas A Waldmann, M.D.
• Affiliation: National Cancer Institute (NCI)

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

Patients must meet all of the following criteria at the time of enrollment.

1. 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.

2. 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
eligible.

1. 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
disease.

2. 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.

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

4. LGL: Patients with large granular lymphocyte leukemia must have
myelosuppression (granulocyte count less than or equal to1,500/microL, platelet
count less than or equal 75,000/microL, or hemoglobin less than or equal 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 eligible.

3. 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
marker.

4. Measurable or evaluable disease.

5. Karnofsky Performance Status greater than or equal to 70%.

6. Life expectancy of greater than 2 months.

7. Granulocyte count greater than or equal to 1,000/mm3 and a platelet count greater
than or equal to 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.

8. Serum creatinine less than or equal to 1.5 mg/dL or 24 hour measured creatinine
clearance greater than 60 ml/min.

9. Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate
transaminase (SGPT) value less than or equal to 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 less than or equal to 5.0-fold greater than the upper limit of
normal) and bilirubin less than or equal to 2.0 mg/dL unless due to Gilbert's
syndrome (unconjugated hyperbilirubinemia) in which case the bilirubin should be less
than or equal to 3.5 mg/dL.

10. 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.

11. 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.

12. Patients must understand and sign an 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:

Patients must have none of the following at the time of enrollment.

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

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

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

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

5. CMV disease or clinically significant CMV antigenemia (determined by prevailing
guidelines).

6. Prior treatment with MEDI-507.

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

8. 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.

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

10. 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.

11. Any general medical, 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.

12. Hypogammaglobulemia (LGL patients only).

13. Diagnosis of NK-cell LGL.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Lymphoproliferative Disorders

Intervention(s)

Drug: MEDI-507

Secondary ID(s)

04-C-0031

040031

Source(s) of Monetary Support

Please refer to primary and secondary sponsors