Clinical trial · Interventional

Vaccine Therapy in Treating Patients With Advanced or Recurrent Cancer

VACCINE THERAPY AND DETECTION OF IMMUNOLOGIC RESPONSES WITH HUMAN PAPILLOMAVIRUS 16 E6 AND E7 PEPTIDES IN PATIENTS WITH METASTATIC OR LOCALLY ADVANCED CERVICAL CANCER

NCT00019110CI-TRIAL-00017705completedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Vaccines made from certain human papillomaviruses may be able to help the body to kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of human papillomavirus vaccine therapy in treating patients who have advanced or recurrent cancer of the cervix, vagina, penis, anus, esophagus, or head and neck.

Conditions

Conditions (6)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Anal Cancer	Malignant Anal Neoplasm	CURATED_EXACT	0.92
Cervical Cancer	Malignant Cervical Neoplasm	CURATED_EXACT	0.92
Esophageal Cancer	Malignant Esophageal Neoplasm	CURATED_EXACT	0.92
Head and Neck Cancer	Malignant Head and Neck Neoplasm	ALIAS	0.90
Penile Cancer	Malignant Penile Neoplasm	CURATED_EXACT	0.92
Vulvar Cancer	Malignant Vulvar Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
human papillomavirus 16 E7 peptide	Biological	—	UNRESOLVED
synthetic human papillomavirus 16 E6 peptide	Biological	—	UNRESOLVED

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically proven stage III, IV, or recurrent carcinoma of the cervix or other tumor that carries human papilloma virus 16 (HPV16) such as other anogenital (vulvar, penile, and anal), esophageal, and head and neck cancers
* HLA-A2.1 positive
* Patients with tumors other than cervical cancer must have no other therapeutic options
* Fresh tissue or paraffin block available for HPV genome detection and typing (optional for cervical cancer)
* No history of CNS metastases

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* ECOG 0-1

Life expectancy:

* More than 3 months

Hematopoietic:

* WBC at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 2.0 mg/dL
* SGPT no greater than 4 times normal

Renal:

* Creatinine no greater than 2.0 mg/dL

Cardiovascular:

* No myocardial infarction within the past 6 months
* No New York Heart Association class III or IV heart disease

Immunologic:

* No autoimmune disease, e.g.:

  * Systemic lupus erythematosus
  * Multiple sclerosis
  * Ankylosing spondylitis
  * HIV negative
* Responsive to 1 of the following skin test antigens:

  * Mumps Trichophyton
  * Candida Tetanus

Other:

* No active infection requiring antibiotics
* No weight loss greater than 20% within the past 6 months
* No other active malignancy except basal cell skin cancer
* 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:

* At least 4 weeks since prior chemotherapy and recovered

Endocrine therapy:

* At least 4 weeks since prior steroids and recovered

Radiotherapy:

* At least 4 weeks since prior radiotherapy and recovered

Surgery:

* Not specified

Other:

* Recovered from the toxic effects of prior therapy

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Nov 1, 1995
Primary completion: —
Completion: —
First posted: Jan 27, 2003
Last update posted: Apr 29, 2015
Lead sponsor: National Cancer Institute (NCI) NIH
Keywords: stage IV anal cancer, recurrent anal cancer, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer, stage IIIA anal cancer, stage IIIB anal cancer, recurrent esophageal cancer, stage III cervical cancer, stage IV cervical cancer, recurrent cervical cancer, stage III vulvar cancer, stage IVB vulvar cancer, recurrent vulvar cancer, stage III penile cancer, stage IV penile cancer, recurrent penile cancer, recurrent metastatic squamous neck cancer with occult primary, metastatic squamous neck cancer with occult primary squamous cell carcinoma, stage III squamous cell carcinoma of the lip and oral cavity, stage III basal cell carcinoma of the lip, stage III verrucous carcinoma of the oral cavity, stage III mucoepidermoid carcinoma of the oral cavity, stage III adenoid cystic carcinoma of the oral cavity, stage IV squamous cell carcinoma of the lip and oral cavity, stage IV basal cell carcinoma of the lip, stage IV verrucous carcinoma of the oral cavity, stage IV mucoepidermoid carcinoma of the oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, recurrent basal cell carcinoma of the lip, recurrent verrucous carcinoma of the oral cavity, recurrent mucoepidermoid carcinoma of the oral cavity, recurrent adenoid cystic carcinoma of the oral cavity, stage III squamous cell carcinoma of the oropharynx, stage III lymphoepithelioma of the oropharynx, stage IV squamous cell carcinoma of the oropharynx, stage IV lymphoepithelioma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, recurrent lymphoepithelioma of the oropharynx, stage III squamous cell carcinoma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, recurrent lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage III squamous cell carcinoma of the larynx, stage III verrucous carcinoma of the larynx, stage IV squamous cell carcinoma of the larynx, stage IV verrucous carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, recurrent verrucous carcinoma of the larynx, stage III squamous cell carcinoma of the paranasal sinus and nasal cavity, stage III inverted papilloma of the paranasal sinus and nasal cavity, stage III midline lethal granuloma of the paranasal sinus and nasal cavity, stage III esthesioneuroblastoma of the paranasal sinus and nasal cavity, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, stage IV inverted papilloma of the paranasal sinus and nasal cavity, stage IV midline lethal granuloma of the paranasal sinus and nasal cavity, stage IV esthesioneuroblastoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent inverted papilloma of the paranasal sinus and nasal cavity, recurrent midline lethal granuloma of the paranasal sinus and nasal cavity, recurrent esthesioneuroblastoma of the paranasal sinus and nasal cavity, recurrent salivary gland cancer, stage IV salivary gland cancer, stage III salivary gland cancer

Brief summary (as posted)

Conditions (6)

Interventions (2)

Eligibility (as posted)

Publications (0)

Locations by country (6)