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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00019266 |
Purpose
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Indinavir may stimulate a person's white blood cells to kill sarcoma cells. Combining vaccine therapy and indinavir with autologous T-cell transplantation may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving vaccine therapy together with indinavir and autologous T-cell transplantation works in treating patients with metastatic or recurrent pediatric sarcomas.
| Condition | Intervention | Phase |
|---|---|---|
|
Sarcoma |
Biological: therapeutic autologous dendritic cells Drug: indinavir sulfate Procedure: peripheral blood stem cell transplantation |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Pilot Study of Autologous T Cell Transplantation With Vaccine Driven Expansion of Anti-Tumor Effectors After Cytoreductive Therapy in Metastatic Pediatric Sarcomas |
| Study Start Date: | December 1997 |
OBJECTIVES:
OUTLINE:
Patients are followed every 6 weeks for 6 months, every 3 months for 6 months, every 6 months for 1 year, and then annually for 3 years.
PROJECTED ACCRUAL: A total of 34-45 patients will be accrued for this study within 1-3 years.
Eligibility| Ages Eligible for Study: | up to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of previously untreated, fusion protein bearing, metastatic malignancies of the following histologic subtypes:
Ewing's sarcoma family of tumors including:
Recurrent disease at least 1 year after completion of prior antineoplastic therapy for children over age 5 (more than 6 months for age 5 and under)
PATIENT CHARACTERISTICS:
Age:
Parts I and II:
Performance status:
Part II:
Life expectancy:
Part II:
Hematopoietic:
Part I:
Part II:
Hepatic:
Part I:
Parts I and II:
Part II:
Renal:
Parts I and II:
Cardiovascular:
Part II:
Pulmonary:
Part I:
Other:
Part I and II:
Part I:
Part II:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Part II:
Endocrine therapy:
Part II:
Radiotherapy:
Part I:
Part II:
Surgery:
Part I:
Part II:
Other:
Part II:
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Crystal Mackall, MD | NCI - Pediatric Oncology Branch |
More Information
| Study ID Numbers: | CDR0000065344, NCI-97-C-0052, NCI-T96-0038 |
| Study First Received: | July 11, 2001 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00019266 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent childhood rhabdomyosarcoma alveolar childhood rhabdomyosarcoma metastatic childhood soft tissue sarcoma recurrent childhood soft tissue sarcoma previously untreated childhood rhabdomyosarcoma |
previously treated childhood rhabdomyosarcoma metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor recurrent Ewing sarcoma/peripheral primitive neuroectodermal tumor childhood malignant mesenchymoma |
|
HIV Protease Inhibitors Anti-HIV Agents Neuroectodermal Tumors, Primitive Indinavir Rhabdomyosarcoma, Childhood Antiviral Agents Ewing's Sarcoma Recurrence Protease Inhibitors Neuroectodermal Tumors Neoplasms, Connective and Soft Tissue |
Sarcoma, Ewing's Malignant Mesenchymal Tumor Soft Tissue Sarcomas Anti-Retroviral Agents Peripheral Neuroectodermal Tumor Sarcoma Neuroepithelioma Ewing's Family of Tumors Neuroectodermal Tumors, Primitive, Peripheral Rhabdomyosarcoma |
|
Anti-Infective Agents HIV Protease Inhibitors Neoplasms by Histologic Type Anti-HIV Agents Indinavir Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Antiviral Agents |
Pharmacologic Actions Protease Inhibitors Neoplasms, Connective and Soft Tissue Neoplasms Anti-Retroviral Agents Therapeutic Uses Sarcoma |