NCT00024687

Brief Summary

Although Neopharm has terminated its sponsorship of this study, it is continuing under the sponsorship of the NCI. Please contact Raffit Hassan, MD at 301-451-8742 for more information. Also see the related NCI study "Experimental Drug SS1(dsFv)-PE38 to Treat Cancer" (Study ID number 010011). SS1(dsFv)-PE38 is an oncology drug product containing a bacteria toxin, fused to a high affinity, disulfide stabilized antibody. The fused protein retains cell killing activity, but binds only to cells expressing mesothelin. Tumors characterized by very high surface mesothelin expression include mesothelioma; epithelial carcinomas of ovary and peritoneum; and squamous cancers of cervix and upper aerodigestive tract, including esophagus, head, and neck cancers. This is a dose-escalating study to determine the maximum tolerated dose (MTD) of intravenous SS1(dsFv)-PE38 administered once every other day for six doses. Dose escalation will proceed in cohorts of 3 until dose-limiting toxicity (DLT) is observed.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2000

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2001

Completed
Last Updated

November 14, 2014

Status Verified

November 1, 2014

First QC Date

September 24, 2001

Last Update Submit

November 13, 2014

Conditions

Neoplasms

Keywords

SS1(dsFv)-PE38 Anti-Mesothelin Immunotoxinadvanced malignancy

Interventions

SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin ImmunotoxinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
-Disease Characteristics- Histopathologic diagnosis of one of the following malignancies: ovarian carcinoma, all non-mucinous epithelial histologies, including primary peritoneal and fallopian tube carcinoma; malignant mesothelioma, except sarcomatous histology; squamous cell cancer of the lung; squamous cell cancer of the cervix; or squamous cell cancer of the head and neck. Tissue block must be available for analysis. Tumor, initial or recurrent, must be positive (at least 30% of tumor cells) for mesothelin by immunohistochemistry. Recurrent unresectable disease after appropriate definitive therapy. At least 4 weeks elapsed since any prior therapy, with recovery from side effects. No concurrent anti-tumor treatment of any kind. Measurable or evaluable tumor documented within 4 weeks prior to study entry. -Patient Characteristics- At least 18 years of age. At least 12-week life expectancy. Performance Status (ECOG) 0-2. Adequate organ function, including: Absolute neutrophil count at least 1,500/mm3; Platelets at least 75,000/mm3; Creatinine, Calcium, and total Bilirubin less than or equal to the upper limit of normal; Liver enzymes AST and ALT less than or equal 2.5 x the upper limit of normal; Albumin at least 3.0 g/dL; Oxygen (O2) saturation more than 93% (room air). Informed Consent signed in accordance with institutional criteria. No known central nervous system (CNS) or spinal cord involvement by tumor. No detectable antibody to SS1(dsFv)-PE38. No concurrent antitumor therapy. No cardiovascular condition NY Heart Association Grade II-IV, or any clinically-significant pericardial effusion. No infection requiring parenteral antibiotics; no HIV infection; and no seropositivity for Hepatitis B and Hepatitis C. Must not be pregnant or nursing. Females of child-bearing potential must use an effective method of contraception.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

NCI/NIH

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

SS1(dsFv)PE38
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 24, 2001

First Posted

September 25, 2001

Study Start

November 1, 2000

Last Updated

November 14, 2014

Record last verified: 2014-11

Locations

US(1)