Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Immunotoxin Therapy in Treating Patients With Advanced Solid Tumors

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase I Treatment Completed 18 and over NCI NCI-03-C-0243 NCI-6221, NCI-SS1PE-002, 6221, NCT00066651

Objectives

Primary

1. Determine the maximum tolerated dose of SS1(dsFv)-PE38 immunotoxin in patients with advanced mesothelin-expressing malignancies.

Secondary

1. Determine the toxic effects of this drug in these patients.
2. Determine the plasma pharmacokinetics of this drug in these patients.
3. Determine the response in patients treated with this drug.
4. Correlate the induction of antibody against this drug with its pharmacokinetics in these patients.

Entry Criteria

Disease Characteristics:

• 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• At least 4 weeks since prior therapy and recovered
• No other concurrent antitumor therapy

Patient Characteristics:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• At least 12 weeks

Hematopoietic

• Absolute neutrophil count at least 1,500/mm³
• Platelet count at least 75,000/mm³

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
  • Seropositive allowed if clinically asymptomatic
  except if clinically asymptomatic and bilirubin and AST and ALT meet the outlined criteria

Renal

• Creatinine no greater than ULN
• Calcium no greater than ULN

Cardiovascular

• No New York Heart Association class II-IV cardiovascular disease

Pulmonary

• 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*
• FEV₁ at least 50% of predicted*

 [Note: *For patients with pleural mesothelioma and as clinically indicated]

Other

• 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%

Expected Enrollment

A total of 3-15 patients will be accrued for this study.

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.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

Raffit Hassan, MD, Protocol chair		Ph: 301-451-8742

Related Information

Web site for additional information
Feautured trial article

Registry Information
Official Title		Phase I Study Of SS1(dsFv)-PE38 Anti-Mesothelin Immunotoxin In Advanced Malignancies: I.V. Infusion QOD Dosing
Trial Start Date		2003-07-28
Registered in ClinicalTrials.gov		NCT00066651
Date Submitted to PDQ		2003-06-27
Information Last Verified		2006-02-01

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