Nelfinavir in Recurrent Adenoid Cystic Cancer of the Head and Neck

NCT01065844 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 200905704
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nelfinavir

Outcome Measures

Primary Outcomes (1)

• Tumor Progression

  Tumor progression as defined by RECIST version v1.1 criteria with ordinal measurements of complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD).

  Every 1 to 3 months

Study Arms (1)

Nelfinavir

EXPERIMENTAL

1250 mg Nelfinavir twice daily Monday-Sunday

Drug: Nelfinavir

Interventions

Nelfinavir DRUG

1250 mg Nelfinavir twice daily Monday - Sunday

Nelfinavir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological diagnosis of adenoid cystic carcinoma.
• Cancer should be staged recurrent or end-stage with/without metastases who have failed all other therapy.
• Age ≥ 18 years
• ECOG performance status 0-2 (Karnofsky ≥ 50%, see Appendix A).
• Patients must have normal organ and marrow function as defined below:
• leukocytes ≥ 3,000/mm3
• absolute neutrophil count ≥ 1,500/mm3
• platelets ≥ 100,000/mm3
• total bilirubin \< 1.5 mg/dl OR a stable or a decreasing bilirubin in patients who have undergone placement of an intrabiliary stent
• AST(SGOT) ≤ 2.5 X institutional upper limit of normal
• ALT(SGPT) ≤ 2.5 X institutional upper limit of normal
• creatinine \< 1.5 X institutional upper limit of normal OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
• No known HIV infection. Since NFV is used in HIV patients, we do not want to interfere with the therapy the patient may already be on.
• Not pregnant. The effects of NFV on the developing human fetus have been studied in HIV positive women (21). We do not, however, know the risks along with radiation. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Ability to understand and the willingness to sign a written informed consent document.

You may not qualify if:

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to NFV.
• Uncontrolled diabetes.
• Hemophilia A \& B as increased bleeding during protease inhibitor therapy has been reported (22).
• Patients may not be receiving any other investigational agents. concomitant medications counterindicated for use with nelfinavir
• Pregnant or lactating women: The effects of NFV on the developing human fetus have been studied in HIV positive women (21). In addition, the chemotherapy will be deleterious to the fetus.
• HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with NFV.

Sponsors & Collaborators

• University of Iowa: lead
• Holden Comprehensive Cancer Center: collaborator

Study Sites (1)

The Holden Comprehensive Cancer Center

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

• Gupta AK, Wilke WW, Taylor EN, Bodeker KL, Hoffman HT, Milhem MM, Buatti JM, Robinson RA. Signaling pathways in adenoid cystic cancers: implications for treatment. Cancer Biol Ther. 2009 Oct;8(20):1947-51. doi: 10.4161/cbt.8.20.9596. Epub 2009 Oct 22.

  PMID: 19729990 BACKGROUND

• Hoover AC, Milhem MM, Anderson CM, Sun W, Smith BJ, Hoffman HT, Buatti JM. Efficacy of nelfinavir as monotherapy in refractory adenoid cystic carcinoma: Results of a phase II clinical trial. Head Neck. 2015 May;37(5):722-6. doi: 10.1002/hed.23664. Epub 2014 Jun 18.

  PMID: 24596143 RESULT

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic; Head and Neck Neoplasms

Interventions

Nelfinavir

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Favorable selection criteria were used in study design. RECIST assessed at a median interval of 12 weeks - this difference in methods may have artificially prolonged the progression free survival observed in this study.

Results Point of Contact

• Title: John M. Buatti, M.D., Chair, Department of Radiation Oncology
• Organization: The University of Iowa

john-buatti@uiowa.edu

319-356-2699

Study Officials

• John M. Buatti, M.D.

  University of Iowa

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chair of Radiation Oncology

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 9, 2010
• Study Start: October 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: November 1, 2017
• Last Updated: October 9, 2019
• Results First Posted: December 19, 2016

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)