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

NCT ID: NCT00019331

Last Updated: 2013-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1997-10-31
• Study Completion Date: 2007-05-31

Brief 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.

Detailed 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.

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

Study Design

• Primary Study Purpose: TREATMENT

Interventions

aldesleukin

Intervention Type: BIOLOGICAL

ras peptide cancer vaccine

Intervention Type: BIOLOGICAL

sargramostim

Intervention Type: BIOLOGICAL

DetoxPC

Intervention Type: DRUG

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Principal Investigators

Barry L. Gause, MD

Role: STUDY_CHAIR

National Cancer Institute (NCI)

Locations

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, United States

Countries

United States

Other Identifiers

NCI-97-C-0141F

Identifier Type: -

Identifier Source: secondary_id

NCI-T96-0078

Identifier Type: -

Identifier Source: secondary_id

CDR0000065656

Identifier Type: -

Identifier Source: org_study_id

NCT00001581

Identifier Type: -

Identifier Source: nct_alias