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A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECT OF CISPLATIN/EPINEPHRINE INJECTABLE GEL (PRODUCT MPI 5010) WHEN ADMINISTERED INTRATUMORALLY FOR ACHIEVEMENT OF TREATMENT GOALS IN RECURRENT OR REFRACTORY SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECT OF CISPLATIN/EPINEPHRINE INJECTABLE GEL (PRODUCT MPI 5010) WHEN ADMINISTERED INTRATUMORALLY FOR ACHIEVEMENT OF TREATMENT GOALS IN RECURRENT OR REFRACTORY SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK


OBJECTIVES: I. Compare the effect of intratumoral injection of a cisplatin/epinephrine gel
(CDDP-e TI) to placebo gel for local control of recurrent or refractory squamous cell
carcinoma of the head and neck. II. Assess achievement of a preselected (by the
investigator) treatment goal for the most troublesome tumor in patients with recurrent or
refractory squamous cell carcinoma of the head and neck following up to 6 weekly
intratumoral treatments with CDDP-e TI vs. placebo gel. III. Compare the effect of CDDP-e TI
to placebo gel on total local tumor volume per patient. IV. Evaluate the time to response
and time to progression for the most troublesome tumor after local treatment with CDDP-e TI
vs. placebo gel. V. Assess the improvement in or stabilization of quality of life in these
patients as measured by the FACT-H&N questionnaire. VI. Compare the histopathology of
injected lesions that respond to local treatment.

OUTLINE: Randomized, double-blind study. Randomization weighted 2:1 in favor of Arm I. Arm
I: Intratumoral Chemotherapy. Cisplatin (NSC-119875) and Epinephrine in a bovine collagen
gel, MP 5010, CDDP-e TI. Arm II: Control. NS in a bovine collagen gel, PLCB.

PROJECTED ACCRUAL: Up to 120 evaluable patients will be studied to provide 80 evaluable
patients on Arm I and 40 evaluable patients on Arm II.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the head and
neck that is recurrent or refractory following at least 1 course of therapy Primary or
metastatic tumors involving skin, nodes (palpable and biopsy- proven), subcutaneous
tissue, or muscle allowed No involvement of major artery or any visceral organ Measurable
lesions accessible for direct intratumoral injection with no immediate risk of hemorrhage
or embolization Most troublesome tumor (identified by the investigator) at least 0.5 cc
and no greater than 20 cc Smaller tumors eligible for treatment but not for efficacy
assessment An improvable primary treatment goal (palliative or preventive) for most
troublesome tumor must be identified by the investigator prior to enrollment If multiple
tumors qualify as most troublesome and share the primary physician-selected treatment
goal, the largest tumor is selected Patient may also select a most troublesome tumor and 1
palliative treatment goal for that tumor (need not match the physician-selected tumor or
goal) No fibrotic lesions (e.g., previously irradiated lesion with no subsequent disease
progression) No tumors involving or threatening to invade the carotid or other major
vessel

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100% Life
expectancy: At least 6 months Hematopoietic: Absolute granulocyte count greater than
1,000/mm3 Platelet count greater than 75,000/mm3 Hepatic: Not specified Renal: Creatinine
no greater than 1.5 times normal Cardiovascular: No NYHA class III/IV status No history of
arrhythmia that would increase risk of treatment Other: No hypersensitivity to cisplatin,
bovine collagen, epinephrine, or sulfites No significant history of extracranial carotid
vascular disease from atherosclerosis, radiation therapy or previous carotid artery
surgery No uncontrolled local infection at treatment sites No medical or psychiatric
condition that would preclude informed consent No pregnant or nursing women Adequate
contraception required of fertile patients

PRIOR CONCURRENT THERAPY: More than 28 days since any antineoplastic therapy or therapy
with investigational agents Fully recovered from side effects of prior treatment

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Mack H. Mabry, MD

Investigator Role:

Study Chair

Investigator Affiliation:

SUGEN

Authority:

United States: Federal Government

Study ID:

CDR0000064225

NCT ID:

NCT00002659

Start Date:

May 1995

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the nasopharynx
  • recurrent squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Arizona Cancer CenterTucson, Arizona  85724
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Stanford University Medical CenterStanford, California  94305-5408
Washington University School of MedicineSaint Louis, Missouri  63110
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
Methodist Cancer Center - OmahaOmaha, Nebraska  68114
Evanston Northwestern Health CareEvanston, Illinois  60201
Veterans Affairs Medical Center - TucsonTucson, Arizona  85723
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Oregon Cancer Center at Oregon Health Sciences UniversityPortland, Oregon  97201-3098
Louisiana State University Medical Center - New OrleansNew Orleans, Louisiana  70112
University of New Mexico Cancer Research & Treatment CenterAlbuquerque, New Mexico  87131
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304
Veterans Affairs Medical Center - BaltimoreBaltimore, Maryland  21201
Comprehensive Cancer Center at JFK Medical CenterAtlantis, Florida  33462
University of Kentucky College of MedicineLexington, Kentucky  40536-0084
Louisiana State University Hospital - ShreveportShreveport, Louisiana  71130-3932
Capitol Comprehensive Cancer Care ClinicJefferson City, Missouri  65109
Creighton University Cancer CenterOmaha, Nebraska  68131-2197
Palmetto Richland Memorial HospitalColumbia, South Carolina  29203
Thompson Cancer Survival CenterKnoxville, Tennessee  37916
Boston Cancer GroupMemphis, Tennessee  38119
Southwest Regional Cancer CenterAustin, Texas  78705
University of Texas Southwestern Medical SchoolDallas, Texas  75235-9032
Department of OtolaryngologyMilwaukee, Wisconsin  53226