VNP20009 in Treating Patients With Advanced Solid Tumors

NCT00006254 | Completed Phase 1

• 4 other identifiers: VION-CLI-008CDR0000068187CCF-IRB-3663NCI-V00-1622
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Biological therapies such as VNP20009 use different ways to stimulate the immune system and stop cancer cells from growing. PURPOSE: Phase I trial to study the effectiveness of VNP20009 in treating patients who have advanced solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

salmonella VNP20009 BIOLOGICAL

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed advanced and/or metastatic solid tumors refractory to standard curative or palliative therapy and for which no other conventional therapy exists * Measurable or evaluable metastatic disease * No brain metastases unless previously treated and no evidence of recurrence * No lymphoma or other hematologic malignancy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * At least 3 months Hematopoietic: * Granulocyte count at least 2,000/mm\^3 * Platelet count at least 100,000/mm\^3 * Hematocrit at least 30% (transfusion allowed) * No known bleeding disorder Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * ALT and AST no greater than 1.5 times ULN (3 times ULN if liver metastases present) * Alkaline phosphatase no greater than 1.5 times ULN (3 times ULN if liver metastases present) * PT and PTT no greater than 1.5 times ULN * Hepatitis B surface antigen negative * No chronic active hepatitis B * No end-stage liver disease Renal: * Creatinine no greater than 2.0 mg/dL * No urinary tract stones * No end-stage renal disease Cardiovascular: * No known valvular disease * No known clinically significant atherosclerotic disease, peripheral vascular disease, or arterial aneurysm * No unstable angina * No artificial heart valves Pulmonary: * No severe oxygen-dependent chronic obstructive pulmonary disease Other: * No artificial implant that cannot be removed (e.g., prosthetic hips or knees or other devices) * No permanent central venous catheters * No gallstones * No active infection * No documented Salmonella infection * No tumor fever or fever of unknown origin or cause * Daily maximum temperature no greater than 38.0 degrees Celsius * HIV negative * No documented immunodeficiency * No other life-threatening illness * No history of allergic reaction or hypersensitivity to quinolone or cephalosporin antibiotics * No commercial food handlers, day-care workers, or health-care workers * No patients unable to avoid close personal contact with severely immunosuppressed individuals (e.g., other patients on myelosuppressive cancer chemotherapy) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior biologic therapy and recovered Chemotherapy: * At least 4 weeks since prior cytotoxic chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy: * At least 2 weeks since prior hormonal therapy and recovered * No concurrent steroids that could depress the immune system unless indicated for severe reactions Radiotherapy: * At least 4 weeks since prior radiotherapy and recovered Surgery: * At least 2 weeks since prior surgery and recovered * No prior splenectomy * No concurrent palliative surgery Other: * Recovered from any other prior anticancer therapies * No concurrent antibiotics * No concurrent immunosuppressives or any other medications that could suppress the immune system * No other concurrent treatment for malignancy * No requirement for immediate palliative treatment

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

Sponsors & Collaborators

• Vion Pharmaceuticals: lead

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

VNP 20009

Study Officials

• Mario Sznol, MD

  Vion Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 11, 2000
• First Posted: September 3, 2003
• Study Start: May 1, 2000
• Study Completion: January 1, 2008
• Last Updated: July 18, 2013

Record last verified: 2007-12

Locations

US (2)