Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors
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|ClinicalTrials.gov Identifier: NCT00019331|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
RATIONALE: Vaccines made from a peptide may make the body build an immune response to kill tumor cells. Combining vaccine therapy with interleukin-2 and/or sargramostim may be a more effective treatment for solid tumors.
PURPOSE: Phase II trial to study the effectiveness of vaccine therapy plus interleukin-2 and/or sargramostim in treating adults who have metastatic solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Endometrial Cancer Head and Neck Cancer Liver Cancer Lung Cancer Melanoma (Skin) Pancreatic Cancer Testicular Germ Cell Tumor Unspecified Adult Solid Tumor, Protocol Specific||Biological: aldesleukin Biological: ras peptide cancer vaccine Biological: sargramostim Drug: DetoxPC||Phase 2|
- Determine whether endogenous cellular immunity to a tumor-specific mutated ras protein is present in cancer patients.
- Determine whether vaccination with synthetic peptides corresponding to the tumor's ras mutation with DetoxPC adjuvant, interleukin-2 (IL-2), and/or sargramostim (GM-CSF) can induce or boost a patient's cellular immunity to that particular mutation.
- Determine the type and characteristics of the cellular immune response generated.
- Determine the tolerance to and toxicity spectrum of such peptides given with DetoxPC adjuvant along with IL-2 and/or GM-CSF.
- Correlate immune response with tumor response in patients treated with these regimens.
OUTLINE: Patients are assigned to one of three treatment groups.
- Group I (closed to accrual 6/4/01): Patients receive tumor-specific ras peptide vaccine with DetoxPC subcutaneously (SC) once every 5 weeks for 3 courses. Beginning 4 days after vaccination, patients receive interleukin-2 (IL-2) SC 5 days a week for 2 weeks.
- Group II (closed to accrual 6/4/01): Patients receive sargramostim (GM-CSF) SC daily beginning 1 day prior to the vaccination and continuing for 4 days. Patients receive the vaccination as in group I immediately followed by GM-CSF on day 2. Patients are vaccinated once every 4 weeks for 3 courses.
- Group III: Patients receive the vaccination and IL-2 as in group I and GM-CSF as in group II.
In all groups, patients receive up to 15 vaccinations in the absence of disease progression.
Patients are followed every 2 months.
PROJECTED ACCRUAL: A maximum of 60 patients (20 per treatment group) will be accrued for this study within 2-4 years.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Vaccine Therapy With Tumor Specific Mutated Ras Peptides and IL-2 or GM-CSF for Adult Patients With Solid Tumors|
|Study Start Date :||October 1997|
|Actual Study Completion Date :||May 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00019331
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Barry L. Gause, MD||National Cancer Institute (NCI)|