ADVL1213 – A Phase 1 Study of the TEM-1 Antibody, MORAb-004, in Children with Recurrent or Refractory Solid Tumors
Patients must have relapsed or refractory solid tumors or lymphoma, excluding CNS tumors. Patient’s current disease state must be one for which there are no known curative treatment options or therapies proven to prolong survival with an acceptable quality of life.
MORAb-004 is a humanized IgG antibody directed against TEM-1, which is a glycoprotein that has been demonstrated to express on tumor cells and play a role in tumor growth. MORAb-004 will be administered IV on a weekly schedule. Patients will be given appropriate pre-medications due to the possibility of an infusion-related reaction. Therapy may continue for up to a year if there is no evidence of progressive disease or drug related dose-limiting toxicities.
- Patients must be between 12 months and 21 years of age.
- Patients must have fully recovered from the acute toxic effects of all prior anti-cancer chemotherapy and have the appropriate wash-out period from most recent cancer directed therapy.
- Must have adequate organ function as evidenced by laboratory criteria.
- Patients must not be receiving chronic systemic corticosteroids.
- Must not have known HIV, viral hepatitis, or an uncontrolled infection.
- Must not have a prior history of or known metastatic CNS disease involvement.
- Must not have had or plan to have major surgical procedures within 28 days prior to enrollment or minor procedures (i.e. biopsy, aspirate, port placement) within 7 days prior to enrollment.
- Must not have received a prior solid organ transplantation.
- Patients must not have a history of clinically significant bleeding risk (i.e. evidence of active bleeding, intratumoral hemorrhage, bleeding diathesis, bleeding/coagulation disorder, active fracture, non-healing would, or active gastric ulcer).
For the current status and more detailed eligibility criteria of these clinical studies & protocols, referring physicians and families may call the Developmental Therapeutics Program directly at (832) 824-4266 at any time. Kate Mazur, a pediatric nurse practitioner for the Developmental Therapeutics Program, will answer any questions or concerns you may have. You may need to leave a voice mail, and she will return your call as soon as possible. She may also be reached by email at email@example.com.