A Phase 1/2 Trial of VX15/2503 in Children Adolescents or Young Adults With Recurrent or Relapsed Solid Tumors
James Croop, MD, PhD
Primary Investigator
Brief description of study
This phase I/II trial studies the side effects and best dose of anti-SEMA4D monoclonal antibody VX15/2503 (VX15/2503) and to see how well it works in treating younger patients with solid tumors that have come back after treatment, or do not respond to treatment.
Detailed description of study
The purpose of this study is to estimate the maximum tolerated dose (MTD) and/or recommended Phase 2 dose of VX15/2503 administered as an intravenous infusion every 14 days to children with recurrent or refractory solid tumors; to define and describe the toxicities of VX15/2503 administered on this schedule; to characterize the pharmacokinetics of VX15/2503 in children with recurrent or refractory cancer; to preliminarily define the antitumor activity of VX15/2503 for the treatment of relapsed or refractory osteosarcoma; and to determine if VX15/2503 either improves the disease control rate at 4 months in patients with recurrent measurable osteosarcoma or produces an objective response rate in patients with relapsed or refractory osteosarcoma.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Solid Tumor,Cancer,Recurrent Malignant Solid Neoplasm,Recurrent Osteosarcoma,Refractory Malignant Solid Neoplasm, riley
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Age: Between 1 Years - 30 Years
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Gender: All
Inclusion Criteria
Parts A: Patients with recurrent or refractory solid tumors are eligible, excluding central nervous system (CNS) tumors; patients must have had histologic verification of malignancy at original diagnosis or relapse
Part B: Patients with recurrent or refractory osteosarcoma are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse
Parts A: Patients must have either measurable or evaluable disease
Part B: Patients must have measurable 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
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g. blood count criteria, the patient is considered to have recovered adequately
Patients must not have received prior exposure to VX15/2503
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 for the duration of study therapy
Patients receiving systemic corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible; if used to modify immune adverse events related to prior therapy, >= 14 days must have elapsed since last dose of systemic corticosteroid; Note: patients who are using topical or inhaled corticosteroids are eligible
Patients who are currently receiving another investigational drug are not eligible
Patients who are currently receiving other anti-cancer agents are not eligible (except leukemia patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy)
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 an uncontrolled infection are not eligible
Patients who have received a 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
Additional Information:
Participants will not be paid for their participation.
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