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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 11, 2001 | ||||
| Last Updated Date | February 6, 2009 | ||||
| Start Date ICMJE | December 1997 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00019266 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Autologous T-Cell Transplantation, Vaccine Therapy, and Indinavir in Treating Patients With Metastatic Pediatric Sarcomas | ||||
| Official Title ICMJE | Pilot Study of Autologous T Cell Transplantation With Vaccine Driven Expansion of Anti-Tumor Effectors After Cytoreductive Therapy in Metastatic Pediatric Sarcomas | ||||
| Brief Summary | 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. |
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| Detailed Description | OBJECTIVES:
OUTLINE:
Beginning the same day as peptide-pulsed APDC vaccination, patients receive oral indinavir 3 times daily for 16 weeks. Treatment continues in the absence of unacceptable toxicity or disease progression. 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Sarcoma | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Gender | Both | ||||
| Ages | up to 35 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00019266 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000065344, NCI-97-C-0052, NCI-T96-0038 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | February 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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