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Immunotoxin Therapy in Treating Patients With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT00006981
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 30, 2015
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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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.


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:

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.

Study Design
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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 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: Continuous Infusion X 10 Days
Study Start Date : December 2000

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00006981


Locations
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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
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Study Chair: Robert Kreitman, MD National Cancer Institute (NCI)
More Information
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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.

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ClinicalTrials.gov Identifier: NCT00006981    
Obsolete Identifiers: NCT00006416
Other Study ID Numbers: CDR0000068351
NCI-01-C-0011
NCI-6249
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: May 2005
Keywords provided by National Cancer Institute (NCI):
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
advanced malignant mesothelioma
recurrent malignant mesothelioma
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
cervical squamous cell carcinoma
metastatic squamous neck cancer with occult primary squamous cell carcinoma
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
recurrent squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
recurrent squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the nasopharynx
stage IV 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
Mesothelioma
Fallopian Tube Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
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
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Fallopian Tube Diseases
Immunotoxins
Immunologic Factors