Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase ITreatmentCompleted18 and overNCICDR0000316451
NCI-03-C-0243, NCI-6221, NCI-SS1PE-002, 6221, NCT00066651

Trial Description


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.

Further Study Information



  • 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.

Eligibility Criteria


  • 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

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

    Raffit Hassan, Study Chair

    Link to the current record.
    NLM Identifier NCT00066651 processed this data on May 04, 2015

    Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to