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Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00066651
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : April 30, 2015
Information provided by:
National Cancer Institute (NCI)

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Fallopian Tube Cancer Head and Neck Cancer Lung Cancer Malignant Mesothelioma Ovarian Cancer Pancreatic Cancer Primary Peritoneal Cavity Cancer Biological: SS1(dsFv)-PE38 immunotoxin Phase 1

Detailed Description:



  • Determine the maximum tolerated dose of SS1(dsFv)-PE38 immunotoxin in patients with advanced mesothelin-expressing malignancies.


  • Determine the toxic effects of this drug in these patients.
  • Determine the plasma pharmacokinetics of this drug in these patients.
  • Determine the response in patients treated with this drug.
  • Correlate the induction of antibody against this drug with its pharmacokinetics in these patients.

OUTLINE: This is an open-label, dose-escalation study.

Patients receive a test dose of SS1(dsFv)-PE38 immunotoxin IV over 1-2 minutes on day 1 followed by SS1(dsFv)-PE38 immunotoxin IV over 30 minutes on days 1, 3, and 5. Treatment repeats every 4 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of SS1(dsFv)-PE38 immunotoxin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 3-15 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study Of SS1(dsFv)-PE38 Anti-Mesothelin Immunotoxin In Advanced Malignancies: I.V. Infusion QOD Dosing
Study Start Date : July 2003

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 75,000/mm^3


  • 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


  • Creatinine no greater than ULN
  • Calcium no greater than ULN


  • No New York Heart Association class II-IV cardiovascular disease


  • 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


  • 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%


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • At least 4 weeks since prior therapy and recovered
  • No other concurrent antitumor therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00066651

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United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
United States, North Carolina
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Raffit Hassan, MD National Cancer Institute (NCI)
Layout table for additonal information Identifier: NCT00066651    
Obsolete Identifiers: NCT00065481
Other Study ID Numbers: CDR0000316451
First Posted: August 7, 2003    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: February 2006
Keywords provided by National Cancer Institute (NCI):
epithelial mesothelioma
recurrent malignant mesothelioma
ovarian carcinosarcoma
ovarian clear cell cystadenocarcinoma
ovarian endometrioid adenocarcinoma
ovarian mixed epithelial carcinoma
ovarian serous cystadenocarcinoma
ovarian undifferentiated adenocarcinoma
recurrent ovarian epithelial cancer
Brenner tumor
primary peritoneal cavity cancer
fallopian tube cancer
recurrent pancreatic cancer
cervical squamous cell carcinoma
recurrent cervical cancer
recurrent non-small cell lung cancer
squamous cell lung cancer
recurrent squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
recurrent metastatic squamous neck cancer with occult primary
recurrent salivary gland cancer
salivary gland squamous cell carcinoma
recurrent squamous cell carcinoma of the hypopharynx
recurrent squamous cell carcinoma of the larynx
recurrent squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the nasopharynx
Additional relevant MeSH terms:
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Lung Neoplasms
Pancreatic Neoplasms
Head and Neck Neoplasms
Uterine Cervical Neoplasms
Fallopian Tube Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Fallopian Tube Diseases
Immunologic Factors