NCT00006981

Brief Summary

RATIONALE: Immunotoxins can locate tumor cells and kill them without harming normal cells. Immunotoxin therapy may be an effective treatment for advanced cancer. PURPOSE: Phase I trial to study the effectiveness of immunotoxins in treating patients who have advanced cancer.

Trial Health

80
On Track

Trial Health Score

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

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

December 1, 2000

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

December 6, 2000

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

April 30, 2015

Status Verified

May 1, 2005

First QC Date

December 6, 2000

Last Update Submit

April 29, 2015

Conditions

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

Keywords

recurrent non-small cell lung cancerstage III cervical cancerrecurrent cervical cancerstage IVB cervical cancerstage IVA cervical cancersquamous cell lung cancerstage III ovarian epithelial cancerstage IV ovarian epithelial cancerrecurrent ovarian epithelial canceradvanced malignant mesotheliomarecurrent malignant mesotheliomastage IIIA non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancerrecurrent metastatic squamous neck cancer with occult primaryovarian undifferentiated adenocarcinomaovarian mixed epithelial carcinomaovarian serous cystadenocarcinomaovarian endometrioid adenocarcinomaovarian clear cell cystadenocarcinomacervical squamous cell carcinomametastatic squamous neck cancer with occult primary squamous cell carcinomastage III squamous cell carcinoma of the lip and oral cavitystage IV squamous cell carcinoma of the lip and oral cavityrecurrent squamous cell carcinoma of the lip and oral cavitystage III squamous cell carcinoma of the oropharynxstage IV squamous cell carcinoma of the oropharynxrecurrent squamous cell carcinoma of the oropharynxstage III squamous cell carcinoma of the nasopharynxstage IV squamous cell carcinoma of the nasopharynxrecurrent squamous cell carcinoma of the nasopharynxstage III squamous cell carcinoma of the hypopharynxstage IV squamous cell carcinoma of the hypopharynxrecurrent squamous cell carcinoma of the hypopharynxstage III squamous cell carcinoma of the larynxstage IV squamous cell carcinoma of the larynxrecurrent squamous cell carcinoma of the larynxstage III squamous cell carcinoma of the paranasal sinus and nasal cavitystage IV squamous cell carcinoma of the paranasal sinus and nasal cavityrecurrent squamous cell carcinoma of the paranasal sinus and nasal cavityfallopian tube cancerprimary peritoneal cavity cancerovarian carcinosarcomaBrenner tumoruntreated metastatic squamous neck cancer with occult primaryrecurrent salivary gland cancersalivary gland squamous cell carcinomastage III salivary gland cancerstage IV salivary gland cancerrecurrent pancreatic cancerstage II pancreatic cancerstage III pancreatic cancerovarian mucinous cystadenocarcinomaborderline ovarian surface epithelial-stromal tumorovarian sarcomaovarian stromal cancerstage IV pancreatic cancer

Interventions

SS1(dsFv)-PE38 immunotoxinBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed malignancy, including one of the following: * Malignant mesothelioma * Ovarian epithelial carcinoma (mucinous or nonmucinous), including primary peritoneal or fallopian tube carcinoma * Tumors that may have originated in the bowel (e.g., appendiceal carcinoma) and involve the ovary * Ovarian cancers of other histology are eligible provided they express mesothelin * Pancreatic cancer * Squamous cell lung cancer * Squamous cell cancer of the head and neck * Squamous cell cancer of the cervix * Recurrent unresectable disease after prior standard anticancer therapy that was expected to prolong survival and improve quality of life OR unwilling to receive standard anticancer therapy * At least 30% of initial or recurrent tumor cells positive (at least 1+) for mesothelin by immunohistochemistry * Measurable or evaluable disease * No known CNS or spinal cord involvement * No clinically significant pericardial effusion PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,000/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 Renal: * Creatinine no greater than ULN OR * Creatinine no greater than 2.0 mg/dL if creatinine clearance at least 50 mL/min * Calcium no greater than ULN Cardiovascular: * No New York Heart Association class II-IV heart disease Pulmonary: * Oxygen saturation (SO\_2) more than 92% on room air Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * HIV negative * No detectable antibody to SS1(dsFv)-PE38 * No infection requiring parenteral antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 1 week since prior hematopoietic growth factor therapy Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified Other: * At least 4 weeks since any prior antitumor 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 (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (3)

  • Kreitman RJ, Hassan R, Fitzgerald DJ, Pastan I. Phase I trial of continuous infusion anti-mesothelin recombinant immunotoxin SS1P. Clin Cancer Res. 2009 Aug 15;15(16):5274-9. doi: 10.1158/1078-0432.CCR-09-0062. Epub 2009 Aug 11.

    PMID: 19671873RESULT

  • Hassan R, Kreitman R, Strauss L, et al.: SS1(dsFv)-PE38 anti-mesothelin immunotoxin in advanced malignancies: phase I and pharmacokinetic study of alternate-day infusion. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-113, 2002.

    RESULT

  • Kreitman R, Squires D, O'Hagan D, et al.: SS1(dsFv)-PE38 anti-mesothelin immunotoxin in advanced malignancies: phase I study of continuous infusion. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1896, 2002.

    RESULT

MeSH Terms

Conditions

Uterine Cervical NeoplasmsFallopian Tube NeoplasmsHead and Neck NeoplasmsLung NeoplasmsMesothelioma, MalignantOvarian NeoplasmsPancreatic NeoplasmsCarcinoma, Non-Small-Cell LungCarcinoma, Ovarian EpithelialSquamous Cell Carcinoma of Head and NeckBrenner TumorSalivary Gland Neoplasms

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 DiseasesCarcinoma, BronchogenicBronchial NeoplasmsCarcinomaCarcinoma, Squamous CellNeoplasms, FibroepithelialNeoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueMouth NeoplasmsMouth DiseasesStomatognathic DiseasesSalivary Gland Diseases

Study Officials

  • Robert Kreitman, 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

December 6, 2000

First Posted

January 27, 2003

Study Start

December 1, 2000

Last Updated

April 30, 2015

Record last verified: 2005-05

Locations

US(1)