NCT00001564

A Pilot Study of Tumor-Specific Peptide Vaccination and IL-2 With or Without Autologous T Cell Transplantation in Recurrent Pediatric Sarcomas

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

Arm A: Peripheral blood apheresis by harvesting chemotherapy-naive T cells and populations enriched for professional APCs. T cells and APCs are separated from the apheresis product using countercurrent centrifugal elutriation and a monocyte rich fraction is collected. Autologous T cell transplantation during immunotherapy. Arm B: Cell harvesting is performed as soon as possible. Both Arm A and B: Patients receive intravenous infusion of irradiated peptide-pulsed antigen presenting cell vaccination (APC) products as well as intramuscular injection of influenza vaccine on the same day. Recombinant human IL-2 is administered within 4 hours of the peptide pulsed vaccine by continuous intravenous infusion for 4 days per week for 3 successive weeks. Primary toxic effect of this therapy is expected to be related to the IL-2 therapy. Patients with Grade 2 neurologic or cardiac or any Grade 3 or 4 toxic effects will discontinued IL-2 therapy. If toxic effect is not resolved in 72-hours, the patient may remain on study but will not receive any further IL-2.

Detailed description

Nearly all patients with non-metastatic Ewing's sarcoma family of tumors (ESFT) and alveolar rhabdomyosarcoma (AR) have a dramatic initial response to multiagent chemotherapy. However, approximately 30 percent of patients develop recurrent disease for which conventional chemotherapy is ineffective and treatment options are limited. Immunotherapy may represent an effective approach for treatment of recurrent ESFT and AR. Experimental evidence has shown that immune mediated anti-tumor effects can occur in vivo when T cells recognize and respond to antigens present on tumor cells. In ESFT and AR, tumor-specific chromosomal translocations resulting in the production of novel fusion proteins have been identified in the great majority of tumors. Peptides derived from these fusion proteins have been shown to function as tumor antigens for cytolytic T cells in animal studies. This protocol will study the safety, feasibility and efficacy of tumor-specific peptide vaccination administered with interleukin-2 therapy with or without autologous T cell infusions in patients with recurrent ESFT and AR.

Conditions

• Ewing's Sarcoma
• Rhabdomyosarcoma

Interventions

Type	Name	Description
DRUG	EF-1 Peptide
DRUG	EF-2 Peptide
DRUG	PXFK Peptide
DRUG	E7 Peptide
DRUG	IL-2
DRUG	IL-4
DRUG	GM-CSF
DRUG	CD40 Ligand

Timeline

• Start date: 1996-12-23
• Primary completion: 2007-10-25
• Completion: 2007-10-25
• First posted: 1999-11-04
• Last updated: 2019-11-29

Locations

1 site across 1 country: United States