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Immunotoxin Therapy in Treating Patients With Advanced Cancer

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.

Tracking Information
First Received DateDecember 6, 2000
Last Changed DateApril 29, 2015
Start DateDecember 2000
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 and toxic effects of SS1(dsFv)-PE38 immunotoxin in patients with advanced malignancies that express mesothelin.


- 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.

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


- 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



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks


- Absolute neutrophil count at least 1,000/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


- 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


- No New York Heart Association class II-IV heart disease


- Oxygen saturation (SO_2) more than 92% on room air


- 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


Biologic therapy:

- At least 1 week since prior hematopoietic growth factor therapy


- Not specified

Endocrine therapy:

- Not specified


- Not specified


- Not specified


- At least 4 weeks since any prior antitumor therapy and recovered

- No other concurrent antitumor therapy

Administrative Information
SponsorNational Cancer Institute (NCI)
Verification DateMay 2005
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