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Vaccine Therapy and Interleukin-2 With or Without White Blood Cell Transplantation in Treating Patients With Recurrent Sarcomas

This study has been completed.

Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00019279
  Purpose

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill sarcoma cells. Combining vaccine therapy and interleukin-2 with white blood cell transplantation may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of vaccine therapy and interleukin-2 with or without white blood cell transplantation in treating patients who have recurrent sarcoma.


Condition Intervention Phase
Recurrent Childhood Rhabdomyosarcoma
Extraosseous Ewing's Sarcoma/Primitive Neuroectodermal Tumor
Recurrent Ewing's Sarcoma/Primitive Neuroectodermal Tumor
Adult Rhabdomyosarcoma
Recurrent Childhood Soft Tissue Sarcoma
Alveolar Childhood Rhabdomyosarcoma
Recurrent Tumors of the Ewing's Family
Recurrent Adult Soft Tissue Sarcoma
Drug: interleukin-2
Phase II

MedlinePlus related topics:   Cancer    Soft Tissue Sarcoma   

Drug Information available for:   Interleukin-2   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Pilot Study of Tumor Specific Peptide Vaccination and Interleukin-2 With or Without Autologous T-Cell Transplantation in Pediatric Patients With Recurrent Sarcomas

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   December 1997

Detailed Description:

OBJECTIVES: I. Determine whether clinically relevant anti-tumor responses can be generated in patients with recurrent Ewing's sarcoma family of tumors (ESFT) and alveolar rhabdomyosarcoma (AR) by tumor specific peptide vaccination and interleukin-2 (IL-2) therapy with or without autologous T-cell infusion.

II. Determine whether immune responses to tumor specific and non-tumor specific peptides (as measured by biological assays ex vivo) can be generated in patients with recurrent ESFT and AR by tumor specific peptide vaccination and IL-2 therapy, with or without autologous T-cell infusion.

III. Evaluate whether the biological responses correlate with clinical relevant anti-tumor responses in these patients.

IV. Determine whether the breakpoint regions of the tumor specific fusion proteins found in ESFT and AR function as tumor antigens in vivo as evidenced by the existence of peripheral T cells primed to such proteins prior to tumor-peptide vaccination.

V. Assess the feasibility and toxicity of peptide-pulsed antigen presenting cell (APC) vaccination and IL-2 therapy with or without autologous T-cell infusion in patients with recurrent ESFT and AR.

PROTOCOL OUTLINE: Arm I patients: Patients undergo peripheral blood apheresis in which chemotherapy-naive T cells and populations enriched for professional antigen presenting cells (APC) are harvested.

T cells and APCs are separated from the apheresis product using countercurrent centrifugal elutriation and a monocyte-rich fraction is collected.

Autologous T cells are reinfused over 15-30 minutes immediately before vaccination.

Arm II patients: Cell harvesting is performed as soon as possible. Both Arm I and II: Patients receive irradiated peptide-pulsed antigen presenting cell (APC) vaccination subcutaneously (SC) or intradermally once every 14 days for a total of 6 vaccinations. Patients also receive influenza vaccine intramuscularly on the same days as APC vaccinations 1, 3, and 5 and interleukin-2 (IL-2) SC three times weekly for 16 weeks in the absence of unacceptable toxicity. Patients with active CNS disease do not receive IL-2 therapy.

Patients are followed every 6 weeks for 6 months, every 3 months for the next 6 months, every 6 months for the next year, and then annually for the next 3 years.

PROJECTED ACCRUAL:

A maximum of 64 patients will be accrued for this study within 2-3 years.

  Eligibility
Ages Eligible for Study:   up to 30 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Histologically proven alveolar rhabdomyosarcoma (AR) and Ewing's sarcoma family of tumors (ESFT) which includes: Classical, atypical and extraosseous Ewing's sarcoma, primitive peripheral neuroectodermal tumors, peripheral neuroepithelioma, primitive sarcoma of bone, and ectomesenchymoma Confirmed presence of tumor specific fusion protein by documented RT-PCR which corresponds to one of the tumor specific peptides available for vaccination Arm I: May be enrolled in the first phase without RT-PCR documentation, but is required at time of recurrence prior to immunotherapy Arm I patients: Enrolled at time of initial tumor diagnosis, prior to any cytoreductive therapy Arm II patients: Tumor recurrence occurring during or after receiving at least first-line cytoreductive therapy for ESFT and AR No more than two post-recurrence salvage regimens unless peripheral CD4+ T cell number is greater than 400/mm3 Measurable or evaluable disease --Prior/Concurrent Therapy-- Biologic: At least 2 weeks since prior biologic therapy and recovered Chemotherapy: See Disease Characteristics At least 2 weeks since prior chemotherapy and recovered Endocrine: At least 2 weeks since hormonal therapy and recovered No concurrent oral corticosteroids No concurrent estrogen therapy during immunotherapy Radiotherapy: At least 2 weeks since prior radiotherapy and recovered Surgery: Not specified --Patient Characteristics-- Age: 30 and under Performance status: ECOG 0-2 Life expectancy: At least 8 weeks Hematopoietic: Absolute neutrophil count greater than 1,000/mm3 Hemoglobin greater than 9.0 g/dL Platelet count greater than 50,000/mm3 Hepatic: Bilirubin less than 2.0 mg/dL (unless related to involvement by tumor) Transaminases less than 3 times normal (unless related to involvement by tumor) Hepatitis B or C negative Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: No major cardiovascular disorder Cardiac ejection fraction greater than 40% Pulmonary: No major pulmonary disorder Other: Weight greater than 10 kg at time of apheresis Not pregnant or nursing HIV negative If allergic to eggs, egg products, or thimerosal, or have a history of Guillain-Barre syndrome, ineligible to receive influenza vaccine

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00019279

Locations
United States, District of Columbia
Children's National Medical Center    
      Washington, District of Columbia, United States, 20010-2970
United States, Maryland
Pediatric Oncology Branch    
      Bethesda, Maryland, United States, 20892
United States, Minnesota
University of Minnesota Cancer Center    
      Minneapolis, Minnesota, United States, 55455
United States, Pennsylvania
Children's Hospital of Philadelphia    
      Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Texas Children's Cancer Center    
      Houston, Texas, United States, 77030-2399

Sponsors and Collaborators

Investigators
Study Chair:     Crystal Mackall     National Cancer Institute (NCI)    
  More Information


Study ID Numbers:   CDR0000065350, NCI-97-C-0050K, NCI-T96-0037
First Received:   March 1, 2007
Last Updated:   March 1, 2007
ClinicalTrials.gov Identifier:   NCT00019279
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
Ewing's family of tumors  
Ewing's sarcoma/primitive neuroectodermal tumor (PNET)  
adult rhabdomyosarcoma  
adult soft tissue sarcoma  
adult solid tumor  
alveolar childhood rhabdomyosarcoma  
body system/site cancer  
bone cancer  
cancer  
cellular diagnosis, adult soft tissue sarcoma  
cellular diagnosis, childhood rhabdomyosarcoma  
cellular diagnosis, childhood soft tissue sarcoma  
childhood cancer  
childhood rhabdomyosarcoma  
childhood soft tissue sarcoma  
childhood solid tumor
extraosseous Ewing's sarcoma/primitive neuroectodermal tumor
muscle cancer
musculoskeletal cancer
recurrent Ewing's sarcoma/primitive neuroectodermal tumor
recurrent adult soft tissue sarcoma
recurrent childhood rhabdomyosarcoma
recurrent childhood soft tissue sarcoma
recurrent tumors of the Ewing's family
solid tumor
stage, Ewing's family of tumors
stage, Ewing's sarcoma/primitive neuroepitelial tumor
stage, adult soft tissue sarcoma
stage, childhood rhabdomyosarcoma
stage, childhood soft tissue sarcoma

Study placed in the following topic categories:
Neuroectodermal Tumors, Primitive
Bone Neoplasms
Ewing's family of tumors
Malignant mesenchymal tumor
Bone neoplasms
Osteosarcoma
Osteogenic sarcoma
Soft tissue sarcomas
Recurrence
Rhabdomyosarcoma, Embryonal
Neuroectodermal Tumors
Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Sarcoma, Ewing's
Interleukin-2
Neoplasms, Germ Cell and Embryonal
Sarcoma
Neuroepithelioma
Rhabdomyosarcoma, embryonal
Rhabdomyosarcoma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Disease Attributes
Neoplasms by Histologic Type
Myosarcoma
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Pharmacologic Actions
Neoplasms
Pathologic Processes
Neoplasms, Bone Tissue
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Neoplasms, Connective Tissue
Neoplasms, Neuroepithelial
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 31, 2008




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