Study of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: Continuous Infusion for 10 Days

NCT00024674 | Withdrawn Phase 1

• 2 other identifiers: SS1PE-001NCI Study # 01-C-0011
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Although Neopharm has terminated its sponsorship of this study, it is continuing under the sponsorship of the NCI. Please see "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 continuously for 10 days every four weeks for a maximum of four courses of treatment. Dose escalation will proceed in cohorts of 3 until dose-limiting toxicity (DLT) is observed.

Conditions

Neoplasms

Keywords

SS1(dsFv)-PE38; SS1P; anti-mesothelin immunotoxin; advanced malignancy

Interventions

SS1(dsFv)-PE38 DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

-Disease Characteristics- Histopathologic diagnosis of one of the following malignancies: malignant mesothelioma; ovarian carcinoma, all non-mucinous epithelial histologies, including primary peritoneal and fallopian tube carcinoma; squamous cell cancer of the lung; squamous cell cancer of the head and neck; or squamous cell cancer of the cervix. Recurrent unresectable disease after appropriate definitive therapy. Tumor (initial or recurrent; at least 30% of tumor cells) must be positive (at least 1+) for mesothelin by immunohistochemistry. No concurrent anti-tumor treatment. At least 4 weeks since any prior anti-tumor therapy, with recovery from side effects, and at least one week since any hematopoetic growth factor therapy. 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 1,000/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 to 2.5 x the upper limit of normal; Albumin at least 3.0 g/dL; Oxygen (O2) saturation greater than 92% (room air). Signed Informed Consent, 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. Not 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

• INSYS Therapeutics Inc: lead

Study Sites (1)

NCI/NIH

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

SS1(dsFv)PE38

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: February 1, 2001
• Last Updated: November 14, 2014

Record last verified: 2014-11

Locations

US (1)