Know Cancer

or
forgot password

Phase I/Pilot Study of Intralesional Immunotherapy With A Recombinant Avipox Virus Engineered To Express A Triad Of Co-Stimulatory Molecules In Patients With Advanced Squamous Cell Carcinoma Of The Head And Neck


Phase 1
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer, Metastatic Cancer

Thank you

Trial Information

Phase I/Pilot Study of Intralesional Immunotherapy With A Recombinant Avipox Virus Engineered To Express A Triad Of Co-Stimulatory Molecules In Patients With Advanced Squamous Cell Carcinoma Of The Head And Neck


OBJECTIVES:

- Determine the maximum tolerated dose and dose-limiting toxic effects of recombinant
fowlpox-TRICOM vaccine in patients with advanced squamous cell carcinoma of the oral
cavity or oropharynx or nodal or dermal metastases.

- Determine the safety profile of this regimen in these patients.

- Determine the clinical activity of this regimen, in terms of inflammation at injection
site(s) and disease regression or stabilization, in these patients.

OUTLINE: This is a dose-escalation study.

Patients receive recombinant fowlpox-TRICOM vaccine (rF-TRI) intralesionally once on weeks
0, 3, and 8. Beginning on week 16, patients may receive additional rF-TRI once every 8 weeks
in the absence of disease progression or unacceptable toxicity.

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

Patients are followed at 1 year.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage IV squamous cell carcinoma of the oral cavity or
oropharynx or nodal or dermal metastases for which current available treatment is not
likely to offer a survival advantage or result in significant palliation

- Unresectable locoregional recurrence after maximum radiotherapy OR

- Local disease with unresectable distant metastases involving:

- Base of skull

- Prevertebral fascia

- Deep neck muscles

- Carotid artery (requiring resection)

- Nasopharynx and/or pterygoid muscles

- Ineligible to receive radiotherapy to head and neck during study

- Primary intraoral lesions must be measurable and accessible to intralesional
injections

- No metastatic brain lesions, cerebral metastasis, or leptomeningeal disease

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- Zubrod 0-2

Life expectancy:

- At least 2 months

Hematopoietic:

- Absolute neutrophil count greater than 1,000/mm^3

- Platelet count greater than 100,000/mm^3

- Hemoglobin greater than 8 g/dL

Hepatic:

- Bilirubin less than 1.5 mg/dL

- AST/ALT less than 4 times upper limit of normal (ULN)

- PT/PTT less than 1.5 times ULN

Renal:

- Creatinine less than 2.0 mg/dL OR

- Creatinine clearance greater than 60 mL/min

Cardiovascular:

- No evidence of congestive heart failure

- No serious cardiac dysrhythmia

- No evidence of recent prior myocardial infarction on EKG

- No clinical coronary artery disease

Neurologic:

- No history of seizures or concurrent seizure disorder

- No evidence of encephalitis, multiple sclerosis, or other structural brain lesion(s)
by clinical or radiological evaluation

Immunologic:

- No risk of immune system compromise

- HIV negative

- No hypersensitivity to eggs

- No significant history of allergies (e.g., anaphylaxis or angioedema)

Other:

- No active or chronic infection

- No other serious concurrent medical illness

- No other malignancy unless previously treated with curative intent and no evidence of
persistent or recurrent disease

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- At least 4 weeks since prior immunotherapy and recovered

Chemotherapy:

- No more than 2 prior chemotherapy regimens

- At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

- At least 4 weeks since prior systemic corticosteroids

- No concurrent systemic corticosteroids

Radiotherapy:

- See Disease Characteristics

- At least 4 weeks since prior radiotherapy and recovered

- No prior radiotherapy to more than 50% of nodal groups

Surgery:

- More than 4 weeks since prior surgery for primary or metastatic lesions and recovered

- No prior splenectomy

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Susan Rudy, MSN

Investigator Role:

Study Chair

Investigator Affiliation:

National Institute on Deafness and Other Communication Disorders (NIDCD)

Authority:

United States: Federal Government

Study ID:

CDR0000068782

NCT ID:

NCT00021424

Start Date:

June 2001

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • Metastatic Cancer
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the oropharynx
  • skin metastases
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Warren Grant Magnuson Clinical CenterBethesda, Maryland  20892-1182