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Recurrent Salivary Gland CancerPhase 1NCT00081211

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

A Phase 1 study testing PV701 in people with Recurrent Salivary Gland Cancer and Recurrent Squamous Cell Carcinoma of the Hypopharynx, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Phase I trial to study the effectiveness of intratumoral (in the tumor) PV701 in treating patients who have advanced or recurrent unresectable squamous cell carcinoma (cancer) of the head and neck. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PV701
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
Apr 2004to Jul 2004
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 33Show fewer
  • No known brain metastases
  • Performance status - 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
  • More than 4 weeks since prior chemotherapy and recovered
  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Chicago Comprehensive Cancer Center

    Chicago, Illinois, 60637-1470

Other trials in United States

About this study

Official title: A Phase I Study Of PV701 In Patients With Head And Neck Squamous Cell Carcinoma

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

Read the detailed description

OBJECTIVES:

  1. 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.

II. Determine the toxicity of intratumoral PV701 in these patients. III. Determine response rate and time to progression at the injection site in patients treated with this drug.

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.

Being tested
PV701
Medical subject headings
Salivary Gland Neoplasms, Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PV701Biological

    Given intratumorally

Study groups in NCT00081211
Study groupRoleWhat they receive
Treatment (PV701)ExperimentalPatients 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.
Receives: Biological: PV701

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum-tolerated dose (MTD) of PV701 based on the incidence of dose-limiting toxicity (DLT) as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

    Measured: 3 weeks

Secondary outcomes (3)

  1. Toxicity as assessed by NCI CTCAE version 3.0

    Measured: Up to 12 weeks

  2. Response (complete and partial) rate according to Response Evaluation Criteria in Solid Tumors (RECIST) Committee

    Descriptive statistics will be generated for each group.

    Measured: Up to 12 weeks

  3. Time to progression according to RECIST

    Measured: From the time of study entry until tumor growth is determined by physical exam or by radiographic imaging, assessed up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2004 (estimated)
  2. Study startApr 2004
  3. Primary completionJul 2004

Why it stopped: Administratively complete.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00081211
Sponsor's protocol ID
NCI-2012-02723
Other IDs
12157B, N01CM17102, CDR0000360664
Status last verified
Jan 2013
First submitted
7 Apr 2004
Last updated
24 Jan 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PV701 in people with Recurrent Salivary Gland Cancer and Recurrent Squamous Cell Carcinoma of the Hypopharynx, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 33 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Administratively complete.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum-tolerated dose (MTD) of PV701 based on the incidence of dose-limiting toxicity (DLT) as assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 (time frame: 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00081211.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.

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