Intratumoral PV701 in Treating Patients With Advanced or Recurrent Unresectable Squamous Cell Carcinoma of the Head and Neck - Article
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.
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
- Determine the maximum tolerated dose (MTD) of PV701 administered by direct intratumoral injection in patients with advanced or recurrent unresectable squamous cell carcinoma of the head and neck.
- Determine the toxicity of intratumoral PV701 in these patients.
- Determine response rate and time to progression at the injection site in patients treated with this drug.
OUTLINE: This is a dose-escalation study.
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.
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
- 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
- ECOG 0-2
- More than 3 months
- WBC ≥ 3,000/mm^3
- Hemoglobin > 10 g/dL (transfusion permitted)
- Platelet count ≥ 100,000/mm^3
- Bilirubin < 2 times upper limit of normal (ULN)
- AST/ALT ≤ 2.5 times ULN
- Creatinine < 2.5 mg/dL
- No uncontrolled symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
- No history of significantly compromised pulmonary function (i.e. FEV_1 < 50% of predicted) or decreased oxygen saturation of < 95% on room air
- 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
- More than 4 weeks since prior chemotherapy and recovered
- Not specified
- More than 4 weeks since prior radiotherapy and recovered
- More than 4 weeks since prior surgery and recovered
- No other concurrent investigational agents or commercial agents or therapies for treatment of malignancy
- No concurrent antiviral therapy
David M. Gustin, MD, Study Chair, University of Chicago Cancer Research Center
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
Cache Date: April 9, 2005
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