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

• Status: Completed
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Aldesleukin; Sargramostim; Vaccines

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