Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors
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.
Head and Neck Cancer
Testicular Germ Cell Tumor
Unspecified Adult Solid Tumor, Protocol Specific
Biological: ras peptide cancer vaccine
|Study Design:||Primary Purpose: Treatment|
|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|
|Study Completion Date:||May 2007|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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)|