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

Study Overview

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.

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

CDR0000065656
NCI-97-C-0141F
NCI-T96-0078

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2001-07-11	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-06-19
First Submitted that Met QC Criteria 2003-01-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-06-20
First Posted (ESTIMATED) 2003-01-27	Results First Posted N/A	Last Verified 2004-04

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

18 and over

ECOG 0-1

More than 3 months

WBC at least 2,000/mm^3
Platelet count at least 100,000/mm^3

Bilirubin no greater than 2.0 mg/dL
SGOT/SGPT no greater than 4 times normal
No hepatitis B or C infection

Creatinine no greater than 2.0 mg/dL

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

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

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

At least 4 weeks since prior immunotherapy and recovered

See Disease Characteristics
At least 4 weeks since prior chemotherapy and recovered

At least 4 weeks since prior steroids and recovered

See Disease Characteristics
At least 4 weeks since prior radiotherapy and recovered

Not specified

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_CHAIR: Barry L. Gause, MD, National Cancer Institute (NCI)

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

PatientS

Caregivers

Clinical Trial Record