Nelfinavir in Recurrent Adenoid Cystic Cancer of the Head and Neck

NCT01065844 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-10-09

Study results available
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Summary

The purpose of this study is to evaluate the FDA-approved drug nelfinavir (NFV) as an oncologic agent for adenoid cystic cancers of the head and neck.

Specifically, subjects will be asked to take 1250 mg twice daily and follow-up with their medical oncologist as clinically indicated while taking this medication.

Subjects would be evaluated for quality of life issues utilizing the EORTC QLQ-C30 2-page questionnaire.

Subjects would also be evaluated clinically by the oncologist to determine if the NFV was having an anti-neoplastic effect.

The study remains unfunded. Therefore, potential subjects must be willing to provide self-travel to study site. This study requires a screening visit, initial study visit, and monthly follow-up. Subjects are not reimbursed for time, travel, or physician costs.

Conditions

  • Carcinoma, Adenoid Cystic
  • Head and Neck Neoplasms

Interventions

DRUG

Nelfinavir

1250 mg Nelfinavir twice daily Monday - Sunday

Sponsors & Collaborators

  • Holden Comprehensive Cancer Center

    collaborator OTHER
  • University of Iowa

    lead OTHER

Principal Investigators

  • John M. Buatti, M.D. · University of Iowa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2015-05-31
Completion
2017-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01065844 on ClinicalTrials.gov