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.

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.

Eligibility Criteria:
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