NCT00066651

Brief Summary

RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be effective in treating advanced solid tumors. PURPOSE: This phase I trial is studying the side effects and best dose of immunotoxin therapy in treating patients with recurrent unresectable advanced solid tumors.

Trial Health

80
On Track

Trial Health Score

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

Geographic Reach
1 country

2 active sites

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

July 1, 2003

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2003

Completed
Last Updated

April 30, 2015

Status Verified

February 1, 2006

First QC Date

August 6, 2003

Last Update Submit

April 29, 2015

Conditions

Cervical CancerFallopian Tube CancerHead and Neck CancerLung CancerMalignant MesotheliomaOvarian CancerPancreatic CancerPrimary Peritoneal Cavity Cancer

Keywords

ovarian carcinosarcomaovarian clear cell cystadenocarcinomaovarian endometrioid adenocarcinomaovarian mixed epithelial carcinomaovarian serous cystadenocarcinomaovarian undifferentiated adenocarcinomarecurrent ovarian epithelial cancerBrenner tumorprimary peritoneal cavity cancerfallopian tube cancerepithelial mesotheliomarecurrent malignant mesotheliomarecurrent pancreatic cancercervical squamous cell carcinomarecurrent cervical cancerrecurrent non-small cell lung cancersquamous cell lung cancerrecurrent squamous cell carcinoma of the lip and oral cavityrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent metastatic squamous neck cancer with occult primaryrecurrent salivary gland cancersalivary gland squamous cell carcinomarecurrent squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the nasopharynx

Interventions

SS1(dsFv)-PE38 immunotoxinBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed advanced malignancy of 1 of the following types: * Ovarian cancer * All nonmucinous epithelial histologies are eligible * Primary peritoneal cavity cancer * Fallopian tube cancer * Malignant mesothelioma * No sarcomatous histology * Pancreatic cancer * Squamous cell cancer (SCC) of the lung * SCC of the cervix * SCC of the head and neck * Recurrent unresectable disease, meeting 1 of the following criteria: * Previously treated with definitive standard therapy * Patient refused prior standard therapy * Initial or recurrent tumor positive (at least 30% of tumor cells) for mesothelin by immunohistochemistry\* NOTE: \*Immunohistochemical evaluation not required for patients with pancreatic cancer * Measurable or evaluable disease * No clinically significant pericardial effusion * No known CNS or spinal cord involvement by tumor PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 Life expectancy * At least 12 weeks Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 75,000/mm\^3 Hepatic * Bilirubin no greater than upper limit of normal (ULN) * AST and ALT no greater than 2.5 times ULN * Albumin at least 3.0 g/dL * Hepatitis B and C negative * Seropositive allowed if clinically asymptomatic * except if clinically asymptomatic and bilirubin and AST and ALT meet the outlined criteria Renal * Creatinine no greater than ULN * Calcium no greater than ULN Cardiovascular * No New York Heart Association class II-IV cardiovascular disease Pulmonary * Oxygen saturation at least 93% on room air * DLCO at least 50% of predicted\* * Total lung capacity and vital capacity at least 50% of predicted\* * FEV\_1 at least 50% of predicted\* NOTE: \*For patients with pleural mesothelioma and as clinically indicated Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No infection requiring parenteral antibiotics * No HIV infection * Serum neutralizing activity to SS1(dsFv)-PE38 immunotoxin (at 200 ng/mL) no greater than 75% PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified Other * At least 4 weeks since prior therapy and recovered * No other concurrent antitumor therapy

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

Sponsors & Collaborators

Study Sites (2)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Comprehensive Cancer Center at Wake Forest University

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsFallopian Tube NeoplasmsHead and Neck NeoplasmsLung NeoplasmsMesothelioma, MalignantOvarian NeoplasmsPancreatic NeoplasmsCarcinoma, Ovarian EpithelialBrenner TumorCarcinoma, Non-Small-Cell LungSalivary Gland NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

SS1(dsFv)PE38

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesFallopian Tube DiseasesAdnexal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesMesotheliomaAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, MesothelialPleural NeoplasmsEndocrine Gland NeoplasmsOvarian DiseasesEndocrine System DiseasesGonadal DisordersDigestive System NeoplasmsDigestive System DiseasesPancreatic DiseasesCarcinomaNeoplasms, FibroepithelialNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueCarcinoma, BronchogenicBronchial NeoplasmsMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland DiseasesCarcinoma, Squamous Cell

Study Officials

  • Raffit Hassan, MD

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

August 6, 2003

First Posted

August 7, 2003

Study Start

July 1, 2003

Last Updated

April 30, 2015

Record last verified: 2006-02

Locations

US(2)