Clinical Trial: Intratumoral PV701 in Treating Patients With Advanced or Recurrent Unresectable Squamous Cell Carcinoma of the Head and Neck

This study has been completed.

Sponsors and Collaborators: University of Chicago Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Vaccines made from a specially-modified virus such as PV701 may make the body build an immune response to kill tumor cells while leaving normal cells undamaged. Injecting PV701 directly into the tumor may cause a stronger immune response and kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of intratumoral (in the tumor) PV701 in treating patients who have advanced or recurrentunresectablesquamous cell carcinoma (cancer) of the head and neck.

Condition Treatment or Intervention Phase
Head and Neck Cancer
 Drug: PV701
 Procedure: alternative product therapy
 Procedure: biological response modifier therapy
 Procedure: biologically based therapies
 Procedure: cancer prevention intervention
 Procedure: complementary and alternative therapy
 Procedure: non-tumor cell derivative vaccine
 Procedure: vaccine therapy
Phase I

MedlinePlus related topics:  Head and Neck Cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Intratumoral PV701 in Patients With Advanced or Recurrent Unresectable Squamous Cell Carcinoma of the Head and Neck

Further Study Details: 

OBJECTIVES:

OUTLINE: This is a dose-escalation study.

Patients receive intratumoral PV701 once weekly for 3 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of PV701 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, at least 6 evaluable patients are treated at that dose.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study within 6-10 months.

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
  • Locally advanced or recurrent disease
  • Distant metastases in addition to locally advanced disease acceptable
  • Not amenable to available standard treatment or palliative measures
  • At least one target lesion accessible for intratumoral injection, less than 4 cm, and not situated near an airway or major artery
  • Tumor volume(s) must be large enough to receive injection
  • No known brain metastases

PATIENT CHARACTERISTICS: Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months

Hematopoietic

  • WBC ≥ 3,000/mm^3
  • Hemoglobin > 10 g/dL (transfusion permitted)
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin < 2 times upper limit of normal (ULN)
  • AST/ALT ≤ 2.5 times ULN

Renal

  • Creatinine < 2.5 mg/dL

Cardiovascular

  • No uncontrolled symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Pulmonary

  • No history of significantly compromised pulmonary function (i.e. FEV_1 < 50% of predicted) or decreased oxygen saturation of < 95% on room air

Other

  • No history of allergy to eggs or egg-based or chicken embryo-based vaccines
  • No frequent contact with immunocompromised individuals
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance
  • No history of diabetes mellitus requiring oral hypoglycemic agents or insulin
  • No HIV-positive patients receiving combination antiretroviral therapy
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy

  • Not specified

Chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

Surgery

  • More than 4 weeks since prior surgery and recovered

Other

  • No other concurrent investigational agents or commercial agents or therapies for treatment of malignancy
  • No concurrent antiviral therapy

Location Information

Study chairs or principal investigators

David M. Gustin, MD,  Study Chair,  University of Chicago Cancer Research Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000360664; UCCRC-12157B; NCI-1614
Record last reviewed:  October 2004
Last Updated:  October 13, 2004
Record first received:  April 7, 2004
ClinicalTrials.gov Identifier:  NCT00081211
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005