Protocol Number: 97-C-0052

Title:

A Pilot Study of Autologous T-Cell Transplantation with Vaccine Driven Expansion of Anti-Tumor Effectors After Cytoreductive Therapy in Metastatic Pediatric Sarcomas

Number:

97-C-0052

Summary:

This is a single arm study.

The tumor specimen is analyzed for the presence of a fusion protein which corresponds to available peptides. Patients undergo T cell harvest 10 days after an initial priming peptide-pulsed antigen presenting cell (APC) vaccine is performed.

Fresh APCs are utilized for initial priming vaccination. All subsequent vaccinations will use cryopreserved APCs. Minimum number of APCs administered per vaccination is 100,000/kg and maximum is 100,000,000/kg.

Patients undergo cytoreductive therapy for the treatment of their particular malignancy. This therapy usually consists of multiagent chemotherapy in the context of a separate protocol.

Following chemotherapy, infusion of harvested T cells followed by infusion of peptide-pulsed APC vaccinations occurs every 6 weeks for a total of 3 post-priming vaccinations. Influenza vaccine is administered by intramuscular injection concurrent to peptide-pulsed APC vaccines.

IL-2 is administered as a continuous IV infusion for 4 days/week for 3 successive weeks starting on the same day as T cell /peptide-pulsed infusions.

Sponsoring Institute:

National Cancer Institute (NCI)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Many protocols are potentially hazardous, are intended only for use by clinical oncologists in carefully structured settings, and may not prove to bemore effective than standard treatment. A responsible investigator associated with this protocol should be consulted before using this protocol. Dose and schedule modifications are required for patients who develop gastrointestinal, hematologic, neurologic, and biochemical (renal, hepatic, etc.) and/or other abnormalities after the administration of therapy. Additionally, Federal regulations for the protection of human subjects require approval of clinical trials by your local Institutional Review Board.

Keyword(s):

Rhabdomyosarcoma

Ewing's Sarcoma

Immunotherapy

Tumor Vaccine

Interleukin-2

Recruitment Keyword(s):

None

Condition(s):

Ewing's Sarcoma

Rhabdomyosarcoma

Investigational Drug(s):

EF-1 Peptide

PXFK Peptide

E7 Peptide

IL-4

CD40 Ligand

Indinavir

Investigational Device(s):

None

Interventions:

Drug: EF-1 Peptide

Drug: EF-2 Peptide

Drug: PXFK Peptide

Drug: E7 Peptide

Drug: IL-2

Drug: IL-4

Drug: CD40 Ligand

Drug: GM-CSF

Drug: Indinavir

Supporting Site:

National Cancer Institute

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

A mutant p53 tumor suppressor protein is a target for peptide-induced CD8+ cytotoxic T cells

Thymic-independent T cell regeneration occurs via antigen driven expansion of peripheral T cells resulting in a repertoire that is limited in diversity and prone to skewing

Age, thymopoiesis and CD4+ T lymphocyte regeneration after intensive chemotherapy

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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