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Phase I Study Of SS1(dsFv)-PE38 Anti-Mesothelin Immunotoxin In Advanced Malignancies: I.V. Infusion QOD Dosing

Phase 1
18 Years
Not Enrolling
Cervical Cancer, Fallopian Tube Cancer, Head and Neck Cancer, Lung Cancer, Malignant Mesothelioma, Ovarian Cancer, Pancreatic Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

Phase I Study Of SS1(dsFv)-PE38 Anti-Mesothelin Immunotoxin In Advanced Malignancies: I.V. Infusion QOD Dosing



- 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.

Inclusion 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


- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Raffit Hassan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

July 2003

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Fallopian Tube Cancer
  • Head and Neck Cancer
  • Lung Cancer
  • Malignant Mesothelioma
  • Ovarian Cancer
  • Pancreatic Cancer
  • Primary Peritoneal Cavity Cancer
  • 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
  • epithelial mesothelioma
  • recurrent malignant mesothelioma
  • 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
  • Uterine Cervical Neoplasms
  • Head and Neck Neoplasms
  • Lung Neoplasms
  • Mesothelioma
  • Ovarian Neoplasms
  • Pancreatic Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Comprehensive Cancer Center at Wake Forest University Winston-Salem, North Carolina  27157-1082
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182