Study of the TEM-1 Antibody, MORAb-004 (IND# 103821), in Children With Recurrent or Refractory Solid Tumors

Inclusion Criteria:

- Patients with relapsed or refractory solid tumors or lymphoma, excluding central
nervous system (CNS) tumors, are eligible; patients must have had histologic
verification of malignancy at original diagnosis or relapse; (patients with primary
CNS tumors, known CNS metastases, or a prior history of CNS metastases are not
eligible)

- Patients must have either measurable or evaluable disease

- Patient's current disease state must be one for which there is no known curative
therapy or therapy proven to prolong survival with an acceptable quality of life

- Karnofsky >= 50% for patients > 16 years of age and Lansky >= 50 for patients =< 16
years of age; Note: patients who are unable to walk because of paralysis, but who are
up in a wheelchair, will be considered ambulatory for the purpose of assessing the
performance score

- Patients must have fully recovered from the acute toxic effects of all prior
anti-cancer chemotherapy

- At least 21 days after the last dose of myelosuppressive chemotherapy (42 days if
prior nitrosourea)

- At least 14 days after the last dose of a long-acting growth factor (e.g. Neulasta)
or 7 days for short-acting growth factor; for agents that have known adverse events
occurring beyond 7 days after administration, this period must be extended beyond the
time during which adverse events are known to occur; the duration of this interval
must be discussed with the study chair

- At least 7 days after the last dose of a biologic agent; for agents that have known
adverse events occurring beyond 7 days after administration, this period must be
extended beyond the time during which adverse events are known to occur; the duration
of this interval must be discussed with the study chair

- At least 42 days after the completion of any type of immunotherapy, e.g. tumor
vaccines

- At least 3 half-lives of the antibody after the last dose of a monoclonal antibody

- At least 14 days after local palliative radiotherapy (XRT) (small port); at least 150
days must have elapsed if prior total-body irradiation (TBI), craniospinal XRT or if
>= 50% radiation of pelvis; at least 42 days must have elapsed if other substantial
bone marrow (BM) radiation

- No evidence of active graft vs. host disease and at least 56 days must have elapsed
after transplant or stem cell infusion

- For patients with solid tumors without known bone marrow involvement:

- Peripheral absolute neutrophil count (ANC) >= 1000/mm^3

- Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving
platelet transfusions for at least 7 days prior to enrollment)

- For patients with known bone marrow metastatic disease:

- ANC >= 750/mm^3

- Platelet count >= 75,000/mm^3 (transfusion independent, defined as not receiving
platelet transfusions for at least 7 days prior to enrollment)

- Patients with known bone marrow metastatic disease will not be evaluable for
hematologic toxicity; these patients must not be known to be refractory to red cell
or platelet transfusion; at least 5 of every cohort of 6 patients with a solid tumor
or lymphoma must be evaluable for hematologic toxicity; if dose-limiting hematologic
toxicity is observed, all subsequent patients enrolled must be evaluable for
hematologic toxicity

- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >=
70ml/min/1.73 m^2 OR a serum creatinine based on age/gender as follows:

- =< 0.6 mg/dL for patients age 1 to < 2 years

- =< 0.8 mg/dL for patients age 2 to < 6 years

- =< 1 mg/dL for patients age 6 to 10 2 years

- =< 1.2 mg/dL for patients age 10 to < 13 years

- =< 1.4 mg/dL for female patients age >= 13 years

- =< 1.5 mg/dL for male patients age 13 to < 16 years

- =< 1.7 mg/dL for male patients age >= 16 years

- Bilirubin (sum of conjugated + unconjugated) =< 1.5 x upper limit of normal (ULN) for
age

- Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 110
U/L; for the purpose of this study, the ULN for SGPT is 45 U/L

- Serum albumin >= 2 g/dL

- Activated partial thromboplastin time (aPTT) and prothrombin time (PT) =< 1.5 x ULN

- All patients and/or their parents or legally authorized representatives must sign a
written informed consent; assent, when appropriate, will be obtained according to
institutional guidelines

Exclusion Criteria:

- Pregnant or breast-feeding women will not be entered on this study; pregnancy tests
must be obtained in girls who are post-menarchal; males or females of reproductive
potential may not participate unless they have agreed to use an effective
contraceptive method

- Patients receiving chronic systemic corticosteroids are not eligible

- Patients who are currently receiving another investigation drug are not eligible

- Patients who are currently receiving other anti-cancer agents are not eligible

- Patients who are receiving cyclosporine, tacrolimus or other agents to prevent
graft-versus-host disease post bone marrow transplant are not eligible for this trial

- Patients who have known human immunodeficiency virus (HIV), viral hepatitis, or an
uncontrolled infection are not eligible

- Patients with primary CNS tumors are excluded

- Patients with prior history of or known metastatic CNS disease involvement are
excluded; (Note: CNS imaging for patients without a known history of CNS disease is
only required if clinically indicated)

- Patients who have had or are planning to have the following invasive procedures are
not eligible:

- Major surgical procedure, laparoscopic procedure, open biopsy or significant
traumatic injury within 28 days prior to enrollment

- Central line placement or subcutaneous port placement is not considered major
surgery but must be placed at least 3 days prior to enrollment for external
lines (e.g. Hickman or Broviac) and at least 7 days prior to enrollment for
subcutaneous port

- Core biopsy within 7 days prior to enrollment

- Fine needle aspirate within 7 days prior to enrollment

- Patients who have received prior solid organ transplantation are not eligible

- Patients who in the opinion of the investigator may not be able to comply with the
safety monitoring requirements of the study are not eligible

- Patients with a history of grade >= 2 allergic reaction to a prior monoclonal
antibody therapy are not eligible; patients who have experienced an anaphylactic
reaction to a prior monoclonal antibody are not eligible

- Patients with history of clinically significant bleeding risk (including evidence of
active bleeding: intratumoral hemorrhage by current imaging, or bleeding diathesis;
bleeding/coagulation disorder; active fracture; non-healing wound; and active gastric
ulcer) are not eligible