Mesothelioma Related Clinical Trials:
Phase I Study Of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: Continuous Infusion X 10 Days

Article Tools:

In Page Navigation: - General Info - Purpose - Eligibility - Contacts & Locations - Additional Information

   

Status: Completed
Sponsors and Collaborators: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00006981

Condition: Cervical Cancer; Fallopian Tube Cancer; Head and Neck Cancer; Lung Cancer; Malignant Mesothelioma; Ovarian Cancer; Pancreatic Cancer; Peritoneal Cavity Cancer
Intervention: Drug: SS1(dsFv)-PE38 immunotoxin; Procedure: immunotoxin therapy; Procedure: monoclonal antibody therapy

    - Return To Top

Purpose:


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.

Study Type:   Interventional
Study Design:   Treatment, Open Label
Official Title:   Phase I Study Of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: Continuous Infusion X 10 Days

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   December 2000

Detailed Description:

OBJECTIVES:

Primary

  • Determine the maximum tolerated dose and toxic effects of SS1(dsFv)-PE38 immunotoxin in patients with advanced malignancies that express mesothelin.

Secondary

  • Determine the response in patients treated with this drug.
  • Determine the plasma pharmacokinetics of this drug in these patients.

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

Patients receive SS1(dsFv)-PE38 immunotoxin IV continuously on days 1-10. Treatment repeats every 4 weeks for a maximum of 4 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 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

    - Return To Top

Eligibility:

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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

    - Return To Top

Contacts and Locations:

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006981
Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support    
      Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators
National Cancer Institute (NCI)

Investigators
Study Chair:     Robert Kreitman, MD     National Cancer Institute (NCI)    

    - Return To Top

Additional Information:

Publications of Results:
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.
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.

Study ID Numbers:   CDR0000068351, NCI-01-C-0011, NCI-6249
First Received:   December 6, 2000
Last Updated:   October 25, 2007
ClinicalTrials.gov Identifier:   NCT00006981
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
advanced malignant mesothelioma  
recurrent malignant mesothelioma  
recurrent non-small cell lung cancer  
stage III cervical cancer  
recurrent cervical cancer  
stage IVB cervical cancer  
stage IVA cervical cancer  
squamous cell lung cancer  
stage III ovarian epithelial cancer  
stage IV ovarian epithelial cancer  
recurrent ovarian epithelial cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent metastatic squamous neck cancer with occult primary
ovarian undifferentiated adenocarcinoma
ovarian mixed epithelial carcinoma
ovarian serous cystadenocarcinoma
ovarian endometrioid adenocarcinoma
ovarian clear cell cystadenocarcinoma

Study placed in the following topic categories:
Thoracic Neoplasms
Pancreatic Neoplasms
Malignant mesenchymal tumor
Urogenital Neoplasms
Ovarian epithelial cancer
Lung Neoplasms
Metastatic squamous neck cancer with occult primary
Laryngeal carcinoma
Endocrine Gland Neoplasms
Non-small cell lung cancer
Digestive System Neoplasms
Genital Neoplasms, Female
Carcinoma
Lung Diseases
Sarcoma
Gastrointestinal Neoplasms
Pancreatic Diseases
Carcinoma, Squamous Cell
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Mesothelioma
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Immunologic Factors
Neoplasms, Mesothelial
Physiological Effects of Drugs
Endocrine System Diseases
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Female Urogenital Diseases and Pregnancy Complications
Neoplasms by Site
Digestive System Diseases
Female Urogenital Diseases
Respiratory Tract Diseases

    - Return To Top

Free case consultation

If you or a loved one has been diagnosed with mesothelioma or another asbestos-related disease, contact us using the form below to speak with a mesothelioma consultant, free of charge.