NIH Clinical Research Studies

Protocol Number: 97-C-0141

Active Followup, Protocols NOT Recruiting New Patients

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:
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:
PROTICD
Keywords:
Immunotherapy
Colon Cancer
Pancreatic Cancer
Lung Cancer
Recruitment Keywords:
None
Conditions:
Colonic Neoplasm
Lung Neoplasm
Neoplasm
Pancreatic Neoplasm
Thyroid Neoplasm
Investigational Drug(s):
Detox
Ras Peptide
IL-2
GM-CSF
Investigational Device(s):
None

Contacts:
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:
P53: a frequent target for genetic abnormalities in lung cancer

Mutation in the p53 gene are frequent in primary resected non small lung cancer

Ras gene mutation in non small cell lung cancer are associated with shortened survival irrespective of treatment intent

Active Followup, Protocols NOT Recruiting New Patients

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Clinical Center LogoWarren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
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