MORAb-004 in Treating Young Patients With Recurrent or Refractory Solid Tumors or Lymphoma
Condition: Adult Nasal Type Extranodal NK/T-cell Lymphoma; Anaplastic Large Cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Childhood Burkitt Lymphoma; Childhood Diffuse Large Cell Lymphoma; Childhood Immunoblastic Large Cell Lymphoma; Childhood Nasal Type Extranodal NK/T-cell Lymphoma; Cutaneous B-cell Non-Hodgkin Lymphoma; Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue; Hepatosplenic T-cell Lymphoma; Intraocular Lymphoma; Nodal Marginal Zone B-cell Lymphoma; Noncutaneous Extranodal Lymphoma; Peripheral T-cell Lymphoma; Post-transplant Lymphoproliferative Disorder; Recurrent Adult Burkitt Lymphoma; Recurrent Adult Diffuse Large Cell Lymphoma; Recurrent Adult Diffuse Mixed Cell Lymphoma; Recurrent Adult Diffuse Small Cleaved Cell Lymphoma; Recurrent Adult Grade III Lymphomatoid Granulomatosis; Recurrent Adult Hodgkin Lymphoma; Recurrent Adult Immunoblastic Large Cell Lymphoma; Recurrent Adult Lymphoblastic Lymphoma; Recurrent Adult T-cell Leukemia/Lymphoma; Recurrent Childhood Anaplastic Large Cell Lymphoma; Recurrent Childhood Grade III Lymphomatoid Granulomatosis; Recurrent Childhood Large Cell Lymphoma; Recurrent Childhood Lymphoblastic Lymphoma; Recurrent Childhood Small Noncleaved Cell Lymphoma; Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma; Recurrent Grade 1 Follicular Lymphoma; Recurrent Grade 2 Follicular Lymphoma; Recurrent Grade 3 Follicular Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Marginal Zone Lymphoma; Recurrent Mycosis Fungoides/Sezary Syndrome; Recurrent Small Lymphocytic Lymphoma; Recurrent/Refractory Childhood Hodgkin Lymphoma; Refractory Hairy Cell Leukemia; Small Intestine Lymphoma; Splenic Marginal Zone Lymphoma; T-cell Large Granular Lymphocyte Leukemia; Testicular Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific; Unspecified Childhood Solid Tumor, Protocol Specific; Waldenström Macroglobulinemia
MeSH terms: Burkitt Lymphoma; Mycoses; Lymphoma; Neoplasms; Leukemia; Lymphoma, Follicular; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Hodgkin Disease; Lymphoma, Mantle-Cell; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, B-Cell, Marginal Zone; Leukemia, Lymphocytic, Chronic, B-Cell; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Large-Cell, Immunoblastic; Plasmablastic Lymphoma; Mycosis Fungoides; Sezary Syndrome; Leukemia, T-Cell; Lymphoma, T-Cell, Cutaneous; Waldenstrom Macroglobulinemia; Leukemia-Lymphoma, Adult T-Cell; Lymphoma, Large-Cell, Anaplastic; Leukemia, Hairy Cell; Lymphomatoid Granulomatosis; Lymphoma, Extranodal NK-T-Cell; Intraocular Lymphoma; Leukemia, Large Granular Lymphocytic; Lymphoproliferative Disorders; Immunoblastic Lymphadenopathy; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial studies the side effects and best dose of MORAb-004 in treating young
      patients with recurrent or refractory solid tumors or lymphoma. Monoclonal antibodies, such
      as MORAb-004, can block cancer growth in different ways. Some block the ability of cancer to
      grow and spread. Others find cancer cells and help kill them or carry cancer-killing
      substances to them
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To estimate the maximum tolerated dose (MTD) and/or recommended phase 2 dose of MORAb-004
      (anti-endosialin/TEM1 monoclonal antibody MORAb-004) administered as an intravenous infusion
      every week to children with refractory solid tumors.

      II. To define and describe the toxicities of MORAb-004 administered on this schedule.

      III. To characterize the pharmacokinetics of MORAb-004 in children with refractory cancer.

      IV. To monitor for the development of human anti-human antibody (HAHA) in children receiving
      MORAb-004.

      SECONDARY OBJECTIVES:

      I. To preliminarily define the antitumor activity of MORAb-004 within the confines of a phase
      1 study.

      II. To examine tumor endothelial marker-1 (TEM-1) and PDGFRB levels in tissue and plasma
      samples as potential biomarkers of MORAb-004 activity.

      III. To correlate baseline expression of TEM-1 and PDGFRB (in issue and plasma)with clinical
      parameters including disease response in an exploratory manner.

      OUTLINE: This is a dose escalation study.

      Patients receive anti-endosialin/TEM1 monoclonal antibody MORAb-004 intravenously (IV) on
      days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 13 courses in the absence of
      disease progression or unacceptable toxicity.
    

Intervention name(s): anti-endosialin/TEM1 monoclonal antibody MORAb-004; pharmacological study; laboratory biomarker analysis
Intervention type(s): Biological; Other; Other
Intervention description(s): Given IV; Correlative studies; Optional correlative studies
Other intervention name(s): MORAb-004; pharmacological studies
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment