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Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors

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.

Tracking Information
First Received DateAugust 6, 2003
Last Changed DateApril 29, 2015
Start DateJuly 2003
Descriptive Information
PhasePhase 1
Study TypeInterventional
  • 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
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.

Recruitment Information
Recruitment StatusCompleted
Ages18 Years - N/A
Accepts Healthy VolunteersNo
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

Administrative Information
SponsorNational Cancer Institute (NCI)
Verification DateFebruary 2006
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