NCT00002475

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Vaccines made from a patient's tumor tissue may make the body build an immune response to kill tumor cells. Chemotherapy combined with vaccine therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining cyclophosphamide with tumor cell vaccine in treating patients who have metastatic cancer or cancer at high risk of recurrence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Apr 1991

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

April 1, 1991

Completed
8.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 10, 2013

Status Verified

November 1, 2008

Enrollment Period

16.7 years

First QC Date

November 1, 1999

Last Update Submit

July 9, 2013

Conditions

Breast CancerColorectal CancerKidney CancerLung CancerMalignant MesotheliomaPancreatic Cancer

Keywords

stage III colon cancerstage IV colon cancerstage IV breast cancerstage IIIA breast cancerrecurrent breast cancerstage IIIB breast cancerrecurrent non-small cell lung cancerstage II pancreatic cancerstage III pancreatic cancerrecurrent pancreatic cancerrecurrent colon cancerstage III renal cell cancerstage IV renal cell cancerrecurrent renal cell cancerextensive stage small cell lung cancerrecurrent small cell lung cancerstage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IIIC breast cancerstage IV non-small cell lung cancerpulmonary carcinoid tumorrecurrent malignant mesotheliomastage IV pancreatic cancer

Outcome Measures

Primary Outcomes (5)

  • Clinical response (patients with evaluable disease)

  • Duration of response (patients with evaluable disease)

  • Survival (patients with evaluable disease)

  • Time to recurrence (patients without evaluable disease)

  • Survival (patients without evaluable disease)

Interventions

allogeneic tumor cell vaccineBIOLOGICAL
autologous tumor cell vaccineBIOLOGICAL
recombinant interferon alfaBIOLOGICAL
recombinant interferon gammaBIOLOGICAL
sargramostimBIOLOGICAL
cyclophosphamideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed cancer not amenable to cure or long-term control by surgery, radiotherapy, chemotherapy, or hormonal manipulations, including the following tumor types: * Colon cancer * Lung cancer * Renal cancer * Breast cancer * Pancreatic cancer * Metastatic disease or subclinical disease at high risk of recurrence * No brain metastases unresponsive to irradiation or surgery * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Not specified Menopausal status: * Not specified Performance status: * ECOG 0-2 OR * Karnofsky 70-100% Life expectancy: * At least 3 months Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Cardiovascular: * No prior or concurrent significant cardiovascular disease Pulmonary: * No prior or concurrent pulmonary disease Other: * No prior or concurrent autoimmune disease * No other prior or concurrent major medical illness * HIV negative * No clinical evidence of AIDS * Not pregnant PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy Endocrine therapy: * See Disease Characteristics * At least 4 weeks since prior hormonal therapy * No concurrent chronic steroid therapy Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy Surgery: * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (1)

St. Vincent Medical Center - Los Angeles

Los Angeles, California, 90057-1901, United States

Location

Related Publications (1)

  • Wiseman C, Presant C, Rao R, Smith J. Clinical responses to intralymphatic whole-cell melanoma vaccine augmented by in vitro incubation with alpha-interferon. Ann N Y Acad Sci. 1993 Aug 12;690:388-91. doi: 10.1111/j.1749-6632.1993.tb44040.x. No abstract available.

    PMID: 8368765RESULT

MeSH Terms

Conditions

Breast NeoplasmsColorectal NeoplasmsKidney NeoplasmsLung NeoplasmsMesothelioma, MalignantPancreatic NeoplasmsColonic NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Renal CellSmall Cell Lung Carcinoma

Interventions

FANG vaccineInterferon-alphaInterferon-gammasargramostimCyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesUrologic NeoplasmsUrogenital NeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesMesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, MesothelialPleural NeoplasmsEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System DiseasesCarcinoma, BronchogenicBronchial NeoplasmsAdenocarcinomaCarcinoma

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsMacrophage-Activating FactorsLymphokinesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Charles L. Wiseman, MD, FACP

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 27, 2003

Study Start

April 1, 1991

Primary Completion

December 1, 2007

Study Completion

June 1, 2009

Last Updated

July 10, 2013

Record last verified: 2008-11

Locations

US(1)