Therapy to Treat Ewing's Sarcoma, Rhabdomyosarcoma or Neuroblastoma
Status:
Completed
Trial end date:
2018-05-15
Target enrollment:
Participant gender:
Summary
Background:
- Pediatric solid tumors (Ewing's sarcoma, rhabdomyosarcoma, and neuroblastoma) are often
difficult to cure with standard treatment.
- Immune therapy using an experimental vaccine made from proteins from the patient's tumor
cells may boost the body's immune response against the tumor.
- The effects of chemotherapy on the immune system can potentially make immunotherapy more
effective if administered soon after completion of chemotherapy. The addition of
recombinant human IL-7 (interleukin 7) (rhIL-7 (recombinant human interleukin 7)) may
make the immunotherapy more effective.
Objectives:
-To determine whether immune therapy given after immune suppression can help the body fight
the tumor and to determine the safety of the treatment.
Eligibility:
-Patients with solid tumors, i.e., Ewing's sarcoma, rhabdomyosarcoma or neuroblastoma whose
disease has recurred after treatment or spread beyond the original site
Design:
- Patients undergo tumor biopsy (removal of a piece of tumor tissue) to collect tumor
cells for making a vaccine from proteins in the patient's tumor and apheresis (removal
of a quantity of white blood cells) to collect white cells for re-building the immune
system after immune therapy. Apheresis is repeated three times during immunotherapy
(weeks 8, 14 and 20).
- After receiving standard chemotherapy for their tumor (and an additional course of
fludarabine and cyclophosphamide to further suppress immunity if needed) patients
receive immune therapy in Cohorts A and B. rhIL-7 is given 48 hours before the vaccine,
as an injection under the skin in an extremity that will not be used for the vaccine in
patients in Cohort B only. You will be watched closely for 6 hours after the rhIL-7 for
any signs of reaction. rhIL-7 will be given before vaccine doses #1, #2, #3, and #4. The
vaccine is given at study weeks 2, 4, 6, 8, 10 and 12. Each vaccine is given as a total
of six separate rhIL-7 followed by injections: three intradermal (like a (tuberculosis)
TB test) on one arm or leg and three subcutaneous (like those for insulin injections for
diabetes). on the other arm or leg. An anesthetic cream may be used to minimize the
discomfort of injections.
- Patients' white cells are returned to them by infusion through a vein on the first day
of immune therapy.
- Imaging studies and immune studies are done at weeks 1, 8 and 20 to determine the
response to treatment on the tumor and on the immune system.