Phase 2 Study of REOLYSIN® in Combination With Paclitaxel and Carboplatin in Patients With Head and Neck Carcinoma

NCT00753038 | Completed Phase 2

• 1 other identifier: REO 015
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this Phase 2 study is to investigate whether intravenous administration of REOLYSIN® therapeutic reovirus in combination with Paclitaxel and Carboplatin is effective and safe in the treatment of squamous cell carcinoma of the head and neck.

Conditions

Carcinoma, Squamous Cell of the Head and Neck

Keywords

carcinoma; squamous cell; head; neck; REOLYSIN; chemotherapy; Carboplatin; Paclitaxel

Outcome Measures

Primary Outcomes (1)

• Determine the objective response rate (complete response (CR) + partial response (PR)) of the treatment regimen in the study population

  For PR or CR, changes in tumor measurements must be confirmed 4 weeks after the criteria for response are first met.

Secondary Outcomes (2)

• Evaluate the safety and tolerability of the treatment regimen in the study population.

  Within 30 days of last dose of REOLYSIN®

• Determine the disease control rate (CR, PR and stable disease (SD)), duration of response, time to disease progression and survival with the treatment regimen in the study population.

  For PR or CR, changes in tumor measurements must be confirmed 4 weeks after the criteria for response are first met. For SD, follow-up measurements must have met the SD criteria at least once after trial entry at a minimum interval of 12 weeks.

Interventions

REOLYSIN® BIOLOGICAL

3E10 TCID50, 1 hour intravenous infusion, administered on Days 1, 2, 3, 4 and 5 of a 21 day cycle

Carboplatin DRUG

5 AUC mg/mL min, 30 min intravenous infusion, given on Day 1 of a 21 day cycle

Paclitaxel DRUG

175 mg/m2, 3 hour intravenous infusion, given on Day 1 of a 21 day cycle

Eligibility Criteria

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

You may qualify if:

• have platinum-refractory metastatic and/or recurrent histologically confirmed stage III/IV squamous cell carcinoma of the head and neck (oral cavity, larynx or pharynx) with no secondary cancers
• have evidence of measurable disease
• have documented progressive disease (PD) on or within 190 days following the completion of treatment of cisplatin-based or carboplatin-based chemotherapy in a recurrent or metastatic setting and if treatment with cetuximab was considered indicated for the patient, documented PD(on or within 190 days of treatment)
• have no continuing acute toxic effect of any prior radiotherapy, chemotherapy or surgical procedures
• have received no chemotherapy, radiotherapy, immunotherapy or hormonotherapy within 28 days
• have ECOG performance score of ≤2
• have life expectancy of at least 3 months
• absolute neutrophils ≥ 1.5 x10\^9/L; platelets ≥100 x10\^9; hemoglobin ≥9.0 g/dL; serum creatinine ≤1.5 xULN; bilirubin ≤1.5 x ULN; AST/ALT ≤2.5xULN
• negative pregnancy test for females of childbearing potential

You may not qualify if:

• have known brain metastasis
• have known bone metastasis
• be on immunosuppressive therapy; have known HIV infection or active hepatitis B or C
• be a pregnant or breast-feeding woman
• have clinically significant cardiac disease
• have dementia or altered mental status that would prohibit informed consent
• have any other severe, acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgement of the Principal Investigator, would make the patient inappropriate for this study

Sponsors & Collaborators

• Oncolytics Biotech: lead

Study Sites (2)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Cancer Therapy and Research Center at UTHSCSA

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma

Interventions

reolysin; Carboplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Monica Mita, MD

  Cancer Therapy and Research Center, Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2008
• First Posted: September 16, 2008
• Study Start: August 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: May 1, 2013
• Last Updated: November 4, 2014

Record last verified: 2014-11

Locations

US (2)