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Protocol Number:
97-C-0141
- Title:
Vaccine Therapy with Tumor Specific Mutated RAS Peptides and IL-2 or GM-CSF for Adult Patients with Solid Tumors
- Number:
97-C-0141
- Summary:
Vaccination is administered to 2 separate groups of 14-30 patients each. Patients in group A are given the vaccination in combination with interleukin-2 (IL-2), and patients in group B are given the vaccination in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF).
The ras peptide and Detox PC mixture is administered subcutaneously every 5 weeks on the IL-2 arm (group A) and every 4 weeks on the GM-CSF arm (group B) for a total of 3 vaccinations.
IL-2 is administered subcutaneously for 5 days a week for 2 weeks starting 4 days after vaccination.
GM-CSF is administered subcutaneously for 4 days starting 1 day prior to the vaccination. On day 2, GM-CSF is administered directly after the vaccination.
If patients show evidence of disease response or stable disease, 3 additional vaccinations will be given.
- Sponsoring Institute:
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National Cancer Institute (NCI)
- Recruitment Detail
- Type:
Follow-up Of Previously Enrolled Subjects Only
- Gender:
Male & Female
- Referral Letter Required:
No
- 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.
- Disease Category:
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PROTICD
- Keywords:
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Immunotherapy
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Colon Cancer
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Pancreatic Cancer
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Lung Cancer
- Recruitment Keywords:
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None
- Conditions:
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Colonic Neoplasm
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Lung Neoplasm
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Neoplasm
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Pancreatic Neoplasm
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Thyroid Neoplasm
- Investigational Drug(s):
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Detox
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Ras Peptide
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IL-2
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GM-CSF
- Investigational Device(s):
- None
- Contacts:
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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.
- Citations:
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P53: a frequent target for genetic abnormalities in lung cancer
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Mutation in the p53 gene are frequent in primary resected non small lung cancer
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Ras gene mutation in non small cell lung cancer are associated with shortened survival irrespective of treatment intent
If you have:
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Warren Grant Magnuson Clinical Center (CC) National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/16/2004
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