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

Phase 2CompletedNCT00019331

National Cancer Institute (NCI)

Overview

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.

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 Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

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

Interventions

aldesleukinBIOLOGICAL

ras peptide cancer vaccineBIOLOGICAL

sargramostimBIOLOGICAL

DetoxPCDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Histologically confirmed solid tumors potentially expressing mutant ras, including colon, lung, pancreas, thyroid, endometrial, head and neck, testicular, hepatocellular, and melanoma * Ras mutations must be one of the following point mutations at codon 12: * Glycine to cysteine * Glycine to aspartic acid * Glycine to valine * Metastatic disease for which no known chemotherapy or radiotherapy would increase survival * Tumor tissue must be available for determination of ras mutation * No prior CNS metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * More than 3 months Hematopoietic: * WBC at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 2.0 mg/dL * SGOT/SGPT no greater than 4 times normal * No hepatitis B or C infection Renal: * Creatinine no greater than 2.0 mg/dL Cardiovascular: * No active ischemic heart disease (New York Heart Association class III or IV) * No myocardial infarction within the past 6 months * No history of congestive heart failure, ventricular arrhythmias, or other arrhythmias requiring therapy Immunologic: * No prior allergy to eggs * No prior autoimmune disease, including the following: * Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia * Systemic lupus erythematosus, Sjogren's syndrome, or scleroderma * Myasthenia gravis * Goodpasture syndrome * Addison's disease, Hashimoto's thyroiditis, or active Graves' disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No other active malignancy except curatively treated carcinoma in situ of the cervix or basal cell skin cancer * No active infection requiring antibiotics * No medical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior immunotherapy and recovered Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: * At least 4 weeks since prior steroids and recovered Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered Surgery: * Not specified

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Data from ClinicalTrials.gov

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