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

NCT00001564 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2019-11-29

No results posted yet for this study

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.

Conditions

  • Ewing's Sarcoma
  • Rhabdomyosarcoma

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Crystal L Mackall, M.D. · National Cancer Institute (NCI)

Study Design

Purpose
TREATMENT

Eligibility

Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1996-12-23
Primary Completion
2007-10-25
Completion
2007-10-25

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00001564 on ClinicalTrials.gov