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| 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 |
| 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 |
| Study Start Date: | December 1997 |
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 |
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| 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 | |
| Study Chair: | Crystal Mackall | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000065350, NCI-97-C-0050K, NCI-T96-0037 |
| Study First Received: | March 1, 2007 |
| Last Updated: | March 1, 2007 |
| ClinicalTrials.gov Identifier: | NCT00019279 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
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Neuroectodermal Tumors, Primitive Bone Neoplasms Osteosarcoma Rhabdomyosarcoma, Childhood Ewing's Sarcoma Recurrence Rhabdomyosarcoma, Embryonal Neuroectodermal Tumors Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Sarcoma, Ewing's Malignant Mesenchymal Tumor |
Analgesics, Non-Narcotic Interleukin-2 Neoplasms, Germ Cell and Embryonal Sarcoma Osteogenic Sarcoma Neuroepithelioma Peripheral Nervous System Agents Analgesics Ewing's Family of Tumors Rhabdomyosarcoma Neoplasms, Glandular and Epithelial |
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Neoplasms, Muscle Tissue Disease Attributes Neuroectodermal Tumors, Primitive Antineoplastic Agents Physiological Effects of Drugs Neoplasms, Nerve Tissue Rhabdomyosarcoma, Embryonal Neoplasms, Connective and Soft Tissue Sarcoma, Ewing's Pathologic Processes Sensory System Agents Neoplasms, Germ Cell and Embryonal Therapeutic Uses Analgesics Rhabdomyosarcoma |
Neoplasms by Histologic Type Myosarcoma Osteosarcoma Recurrence Pharmacologic Actions Neuroectodermal Tumors Neoplasms Neoplasms, Bone Tissue Analgesics, Non-Narcotic Interleukin-2 Sarcoma Peripheral Nervous System Agents Neoplasms, Connective Tissue Neoplasms, Neuroepithelial Central Nervous System Agents |
