NCT00019084

Brief Summary

RATIONALE: Vaccines made from a person's white blood cells mixed with tumor proteins may make the body build an immune response to kill tumor cells. Interleukin-2 may stimulate a person's white blood cells to kill tumor cells. Combining vaccine therapy with interleukin-2 may be an effective treatment for advanced cancer. PURPOSE: Phase II trial to study the effectiveness of a vaccine made with the patients' white blood cells mixed with tumor proteins in treating patients who have advanced cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Feb 1996

Longer than P75 for phase_2 breast-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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1996

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

July 11, 2001

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 23, 2003

Completed
Last Updated

June 20, 2013

Status Verified

April 1, 2007

First QC Date

July 11, 2001

Last Update Submit

June 19, 2013

Conditions

Breast CancerCervical CancerColorectal CancerLung CancerOvarian CancerPancreatic Cancer

Keywords

stage IV colon cancerstage IV breast cancerrecurrent breast cancerrecurrent non-small cell lung cancerstage II pancreatic cancerstage III pancreatic cancerrecurrent pancreatic cancerrecurrent colon cancerrecurrent cervical cancerstage IVB cervical cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial cancerextensive stage small cell lung cancerrecurrent small cell lung cancerstage IV non-small cell lung cancerstage IV pancreatic cancer

Interventions

aldesleukinBIOLOGICAL
mutant p53 peptide pulsed dendritic cell vaccineBIOLOGICAL
ras peptide cancer vaccineBIOLOGICAL
sargramostimBIOLOGICAL
therapeutic autologous lymphocytesBIOLOGICAL
therapeutic tumor infiltrating lymphocytesBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically diagnosed advanced cancer considered incurable by standard therapies and expressing mutant p53 or ras, e.g.: Lung Pancreatic Breast Colon Cervical Ovarian p53 or ras mutation by point mutation, insertion, or deletion in protein-coding sequence Tumor tissue required for p53 or ras mutation determination (paraffin block or fresh tissue) Availability of tumor tissue for cell line preparation and of tumor or lymph node tissues for tumor-infiltrating lymphocyte expansion desired No history of 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/mm3 Lymphocyte count at least 800/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL ALT no greater than 4 times normal No hepatitis B or C Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No myocardial infarction within 6 months No New York Heart Association class III or IV heart disease Immunologic: HIV negative No autoimmune disease, e.g.: Systemic lupus erythematosus Multiple sclerosis Ankylosing spondylitis Responsive to skin antigens Other: No weight loss of greater than 20% in the last 6 months No active infection requiring antibiotics No active second malignancy except basal cell skin cancer or carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy and recovered Chemotherapy: At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: At least 4 weeks since prior steroids and recovered Radiotherapy: 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)

Medicine Branch

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical NeoplasmsColorectal NeoplasmsLung NeoplasmsOvarian NeoplasmsPancreatic NeoplasmsColonic NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Ovarian EpithelialSmall Cell Lung Carcinoma

Interventions

aldesleukinsargramostim

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersPancreatic DiseasesCarcinoma, BronchogenicBronchial NeoplasmsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Samir N. Khleif, 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

May 23, 2003

Study Start

February 1, 1996

Study Completion

May 1, 2003

Last Updated

June 20, 2013

Record last verified: 2007-04

Locations

US(1)