Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
Study of the TEM-1 Antibody, MORAb-004 (IND# 103821), in Children With Recurrent or Refractory Solid Tumors
Verified date | December 2015 |
Source | Morphotek |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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
Status | Completed |
Enrollment | 27 |
Est. completion date | May 2015 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 13 Months to 21 Years |
Eligibility |
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 - Tissue blocks or slides must be sent per Section 8.5. If tissue blocks or slides are unavailable, the study chair must be notified prior to enrollment. 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 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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | C S Mott Children's Hospital | Ann Arbor | Michigan |
United States | Children's Healthcare of Atlanta-Egleston | Atlanta | Georgia |
United States | Children's Hospital of Alabama | Birmingham | Alabama |
United States | Ann and Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois |
United States | Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio |
United States | Rainbow Babies & Children's Hospital | Cleveland | Ohio |
United States | Baylor College of Medicine | Houston | Texas |
United States | Riley Hospital for Children | Indianapolis | Indiana |
United States | Saint Jude Children's Research Hospital | Memphis | Tennessee |
United States | Midwest Children's Cancer Center | Milwaukee | Wisconsin |
United States | University of Minnesota Cancer Center-Fairview | Minneapolis | Minnesota |
United States | Columbia University Medical Center | New York | New York |
United States | Children's Hospital of Orange County | Orange | California |
United States | Children's Hospital of Philadelphia | Philadelphia | Pennsylvania |
United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
United States | Oregon Health and Science University | Portland | Oregon |
United States | University of California San Francisco Medical Center - Parnassus | San Francisco | California |
United States | Seattle Children's Hospital | Seattle | Washington |
United States | Washington University School of Medicine | St. Louis | Missouri |
United States | Children's National Medical Center | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Morphotek | Children's Oncology Group, National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MTD, defined as the maximum dose at which fewer than one-third of patients experience dose-limiting toxicities (DLT) graded according to the revised National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 | Up to 4 weeks | Yes | |
Primary | Incidence of toxicities, graded according to NCI CTCAE version 4.0 | A descriptive summary of all toxicities will be reported. | Up to 3 years | Yes |
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