Phase I Study of SS1(dsFv)-PE38 Immunotoxin in Patients With Advanced Malignancies That Express Mesothelin

(Summary Last Modified 12/22/2004)

PATIENT VERSION OF THE ABSTRACT

Patient Abstract: Immunotixins 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.

Eligibility:

  • At least 18 years old

  • Measurable or evaluable disease

  • No CNS involvement

  • At least 4 weeks since previous anticancer therapy

Treatments: Patients will receive a 10-day continuous infusion of the immunotoxin. Treatment may be repeated every 4 weeks for up to four courses. Patients will receive follow-up evaluations every 3 months.

This abstract is intended to give a brief overview of this clinical trial. To help determine whether the trial is appropriate for an individual, selected major eligibility criteria are listed above. To obtain more details related to trial eligibility and the treatment plan, please see the Health Professional abstract of this clinical trial. For more information about clinical trials, please visit the NCI cancerTrials website at http://cancertrials.nci.nih.gov

Protocol IDs: NCI-01-C-0011, NEOPHARM-MS-CI-01, NEOPHARM-SS1PE-001

Constent to Participate - CLICK HERE

Participating Organizations/Investigators

David Squires, Chair Ph: 301-594-1827
Division of Basic Sciences

Study Contacts

Maryland

Patient Recruitment, Ph: 1-888-NCI-1937
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, U.S.A

North Carolina

Mark C. Willingham, Ph: 336-716-4464
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, U.S.A.

PHYSICIAN VERSION OF THE ABSTRACT

Phase I Study of SS1(dsFv)-PE38 Immunotoxin in Patients With Advanced Malignancies That Express Mesothelin
(Summary Last Modified 02/2002)

Protocol Ids

NCI-01-C-0011, NEOPHARM-MS-CI-01, NEOPHARM-SS1PE-001

Protocol Type:

Treatment

Sponsorship:

NCI-sponsored, pharmaceutical

Status:

Active

Age Range:

18 and over

OBJECTIVES

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

II. Determine the response of patients treated with this regimen.

III. Determine the toxic effects and pharmacokinetics of this drug in this patient population.

ENTRY CRITERIA

--Disease Characteristics--

Histologically confirmed malignancy, including one of the following:

  • Malignant mesothelioma

  • Ovarian epithelial carcinoma (nonmucinous), including primary peritoneal or Fallopian tube carcinoma

  • Squamous cell lung cancer

  • Squamous cell cancer of the head and neck

  • Squamous cell cancer of the cervix

  • Recurrent unresectable disease after definitive 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

--Prior/Concurrent Therapy--

Biologic therapy:

At least 1 week since prior hematopoietic growth factor therapy

Chemotherapy:

Not specified

Endocrine therapy:

Not specified

Radiotherapy:

Not specified

Surgery:

Not specified

Other:

At least 4 weeks since any prior antitumor 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 1,000/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

Renal:

Creatinine no greater than ULN; Calcium no greater than ULN

Cardiovascular:

No New York Heart Association class II-IV heart disease;
No clinically significant pericardial effusion

Pulmonary:

Oxygen saturation (SO2) more than 92% on room air

Other:

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

OUTLINE

This is a 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.

STRATIFICATION

Not abstracted

SPECIAL STUDY PARAMETERS

Not abstracted

END POINTS

Not abstracted

PROJECTED ACCRUAL

A maximum of 30 patients will be accrued for this study.

WARNING

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

DOSAGE SCHEDULE

Not abstracted

DOSAGE FORMS

Not abstracted

PARTICIPATING ORGANIZATIONS/STUDY CONTACTS

David Squires, Chair Ph: 301-594-1827
Division of Basic Sciences

STUDY CONTACTS

Maryland
Patient Recruitment, Ph: 1-888-NCI-1937
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, U.S.A.

North Carolina
Mark C. Willingham, Ph: 336-716-4464
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, U.S.A.

** RE-POSTED JANUARY 18, 2005 **