NCT00019331

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 1997

Longer than P75 for phase_2 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1997

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

June 20, 2013

Status Verified

April 1, 2004

First QC Date

July 11, 2001

Last Update Submit

June 19, 2013

Conditions

Colorectal CancerEndometrial CancerHead and Neck CancerLiver CancerLung CancerMelanoma (Skin)Pancreatic CancerTesticular Germ Cell TumorUnspecified Adult Solid Tumor, Protocol Specific

Keywords

stage IV colon cancerrecurrent non-small cell lung cancerstage II pancreatic cancerstage III pancreatic cancerrecurrent pancreatic cancerrecurrent colon cancerextensive stage small cell lung cancerrecurrent small cell lung canceradvanced adult primary liver cancerrecurrent adult primary liver cancerstage IV endometrial carcinomarecurrent endometrial carcinomastage III malignant testicular germ cell tumorrecurrent malignant testicular germ cell tumorstage IV papillary thyroid cancerstage IV follicular thyroid cancerthyroid gland medullary carcinomaanaplastic thyroid cancerrecurrent thyroid cancerstage IV melanomarecurrent melanomastage IV non-small cell lung cancerunspecified adult solid tumor, protocol specificuntreated metastatic squamous neck cancer with occult primaryrecurrent metastatic squamous neck cancer with occult primaryadult primary hepatocellular carcinomapulmonary carcinoid tumorstage IV squamous cell carcinoma of the lip and oral cavitystage IV basal cell carcinoma of the lipstage IV verrucous carcinoma of the oral cavitystage IV mucoepidermoid carcinoma of the oral cavitystage IV adenoid cystic carcinoma of the oral cavityrecurrent squamous cell carcinoma of the lip and oral cavityrecurrent basal cell carcinoma of the liprecurrent verrucous carcinoma of the oral cavityrecurrent mucoepidermoid carcinoma of the oral cavityrecurrent adenoid cystic carcinoma of the oral cavitystage IV squamous cell carcinoma of the oropharynxstage IV lymphoepithelioma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxrecurrent lymphoepithelioma of the oropharynxstage IV squamous cell carcinoma of the nasopharynxstage IV lymphoepithelioma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxrecurrent lymphoepithelioma of the nasopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the larynxstage IV verrucous carcinoma of the larynxrecurrent squamous cell carcinoma of the larynxrecurrent verrucous carcinoma of the larynxstage IV squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV inverted papilloma of the paranasal sinus and nasal cavitystage IV midline lethal granuloma of the paranasal sinus and nasal cavitystage IV esthesioneuroblastoma of the paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent inverted papilloma of the paranasal sinus and nasal cavityrecurrent midline lethal granuloma of the paranasal sinus and nasal cavityrecurrent esthesioneuroblastoma of the paranasal sinus and nasal cavityinsular thyroid cancerrecurrent salivary gland cancerstage IV salivary gland cancerstage IV pancreatic cancer

Interventions

aldesleukinBIOLOGICAL
ras peptide cancer vaccineBIOLOGICAL
sargramostimBIOLOGICAL
DetoxPCDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsEndometrial NeoplasmsHead and Neck NeoplasmsLiver NeoplasmsLung NeoplasmsMelanomaPancreatic NeoplasmsTesticular Germ Cell TumorColonic NeoplasmsCarcinoma, Non-Small-Cell LungSmall Cell Lung CarcinomaCarcinoma, HepatocellularTesticular NeoplasmsThyroid Cancer, PapillaryAdenocarcinoma, FollicularCarcinoma, MedullaryThyroid Carcinoma, AnaplasticThyroid NeoplasmsSquamous Cell Carcinoma of Head and NeckEsthesioneuroblastoma, OlfactorySalivary Gland Neoplasms

Interventions

aldesleukinsargramostim

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesLiver DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialGenital Neoplasms, MaleGenital Diseases, MaleMale Urogenital DiseasesTesticular DiseasesGonadal DisordersAdenocarcinoma, PapillaryThyroid DiseasesCarcinoma, NeuroendocrineNeoplasms, Ductal, Lobular, and MedullaryCarcinoma, Squamous CellNeuroblastomaNeuroectodermal Tumors, Primitive, PeripheralNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialOlfactory Nerve DiseasesCranial Nerve DiseasesNervous System DiseasesMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Study Officials

  • Barry L. Gause, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

July 11, 2001

First Posted

January 27, 2003

Study Start

October 1, 1997

Study Completion

May 1, 2007

Last Updated

June 20, 2013

Record last verified: 2004-04

Locations

US(1)