Pediatric Cancers
A Pilot Study of Tumor Vaccination and RHIL-7 Following Standard Multimodality Therapy in Patients With High Risk Pediatric Solid Tumors
NCI-07-C-0206, NCT00923351
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Investigator(s): |
Crystal Mackall, M.D.
Principal Investigator
Phone: 301-402-5940
Fax: 301-451-7010
cm35c@mail.nih.gov
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Pediatric Oncology
Phone: 301-496-4256
1-877-624-4878 (Toll free)
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Background:
- Patients with recurrent or metastatic pediatric solid tumors experience low survival rates, but with current standard therapies, many patients with these diseases are rendered into a state of minimal residual disease associated with lymphopenia
- Lymphopenic hosts show augmented immune reactivity, which may be favorable for inducing antitumor immune responses
Objectives:
- Determine whether Alpha CD25 and 8H9 depleted autologous lymphocytes plus tumor lysate/KLH pulsed dendritic cell vaccines plus or minus r-hIL (CYT107) can induce immune responses to tumor lysate in this patient population rendered lymphopenic by cytotoxic therapy
- Assess the safety of administering lymphocytes depleted of CD4 plus CD25 plus suppressor T cells plus or minus r-hIL (CYT107) to lymphopenic hosts
Key Eligibility Criteria:
- Patients with metastatic or recurrent pediatric solid tumors of the following histologies, Ewing’s sarcoma family of tumors, rhabdomyosarcoma, neuroblastoma, synovial cell sarcoma, desmoplastic small round cell tumor, undifferentiated sarcoma, and embryonal sarcoma
- Patients must have sufficient accessible tumor for biopsy to generate tumor lysate
- Patients must meet eligibility criteria upon enrollment and upon completion of standard therapy prior to administration of immunotherapy, as significant time will have elapsed between the time points
Study Outline:
- Immunotherapy consists of one autologous lymphocytes infusion depleted of CD25+ suppressive T cells and depleted of contaminating tumor cells plus six sequential tumor lysate/KLH pulsed dendritic cell vaccines; no cytokine is administered on arm A and r-hIL (CYT107) is administered on arm B
- Patients will be evaluated for immune responses to tumor lysates using ex vivo assays and DTH
- One-stage design targeting a response rate of 50%; up to 47 patients will be treated
- Stopping rules will take effect if excessive toxicity is observed
Additional Information:
- This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
- There is no charge for medical care received at NIH Clinical Center.
- PDQ (Physicians Data Query) - provides additional details about this study for health care providers.
Reviewed: 6/25/12
Updated: 5/21/10
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