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

Sponsor

National Cancer Institute (NCI) (NIH)

Overall Status

Completed

CT.gov ID

NCT00019331

Collaborator

(none)

Location

115

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Biological: aldesleukin Biological: ras peptide cancer vaccine Biological: sargramostim Drug: DetoxPC	Phase 2

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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 1997

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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