Vaccine Therapy Plus Biological Therapy in Treating Adults With Metastatic Solid Tumors

Colorectal Cancer Clinical Trial

Official title: Vaccine Therapy With Tumor Specific Mutated Ras Peptides and IL-2 or GM-CSF for Adult Patients With Solid Tumors

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

OBJECTIVES:

• 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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Endometrial Cancer
• Head and Neck Cancer
• Head and Neck Neoplasms
• Liver Cancer
• Liver Neoplasms
• Lung Cancer
• Melanoma (Skin)
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Pancreatic Cancer
• Pancreatic Neoplasms
• Testicular Germ Cell Tumor
• Testicular Neoplasms
• Unspecified Adult Solid Tumor, Protocol Specific

• NCT number: NCT00019331
• Study type: Interventional
• Source: National Cancer Institute (NCI)
• Status: Completed
• Phase: Phase 2
• Start date: October 1997
• Completion date: May 2007