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Chemotherapy

Recombinant EphB4-HSA Fusion Protein for Head and Neck Squamous Cell Carcinoma

Phase 1
Waitlist Available
Led By Anthony El-Khoueiry
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Amenorrhea >= 12 consecutive months without another cause or For women with irregular menstrual periods and on hormone replacement therapy (HRT), a documented serum follicle stimulating hormone (FSH) level > 35 mIU/mL
Women who are using oral contraceptives, other hormonal contraceptives (vagina products, skin patches, or implanted or injectable products), or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy, or are practicing abstinence or where their partner is sterile (e.g., vasectomy) should be considered to be of childbearing potential
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from start of treatment with recombinant ephb4-hsa fusion protein (start of 2nd course) to death for any cause, assessed up to 2 years
Awards & highlights

Study Summary

This trial is testing the side effects and best dose of a new protein drug when given with standard chemotherapy drugs to treat patients with solid tumors that have spread and can't be cured or controlled with treatment.

Eligible Conditions
  • Head and Neck Squamous Cell Carcinoma
  • Pancreatic Cancer
  • Gallbladder Cancer
  • Non-Small Cell Lung Cancer
  • Cholangiocarcinoma
  • Pancreatic Adenocarcinoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Women have not had a menstrual period for at least 12 months without any other reason, or women with irregular menstrual periods who are taking hormone replacement therapy have a documented FSH level above 35 mIU/mL.
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If you are a woman who is using birth control pills, patches, implants, or IUDs, or if you or your partner is sterile or practicing abstinence to avoid pregnancy, you may still be able to participate in the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from start of treatment with recombinant ephb4-hsa fusion protein (start of 2nd course) to death for any cause, assessed up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and time from start of treatment with recombinant ephb4-hsa fusion protein (start of 2nd course) to death for any cause, assessed up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Duration of overall response or SD
Incidence of toxicities, graded according to Common Terminology Criteria for Adverse Events version 4
Objective response using RECIST version 1.1
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C (sEphB4-HSA, cisplatin, gemcitabine hydrochloride)Experimental Treatment5 Interventions
Patients receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1, 8, and 15 (beginning course 2), cisplatin IV over 120 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (sEphB4-HSA, docetaxel)Experimental Treatment4 Interventions
Patients receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1, 8, and 15 (beginning course 2) and docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Group III: Arm A (sEphB4-HSA, nab-paclitaxel, gemcitabine hydrochloride)Experimental Treatment5 Interventions
Patients receive recombinant EphB4-HSA fusion protein IV over 1 hour on days 1, 8, 15, and 22 (beginning course 2), paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
FDA approved
Albumin human
FDA approved
Docetaxel
FDA approved
Gemcitabine
FDA approved

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor
899 Previous Clinical Trials
1,595,242 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,607 Previous Clinical Trials
40,913,923 Total Patients Enrolled
Vasgene Therapeutics, IncIndustry Sponsor
7 Previous Clinical Trials
245 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What medical conditions commonly call for the treatment of Recombinant EphB4-HSA Fusion Protein?

"Recombinant EphB4-HSA Fusion Protein is prescribed to patients that have had prior adjuvant anthracycline therapy, and can be used to alleviate symptoms related to head maladies, hypoalbuminemia and neoplasm metastasis."

Answered by AI

Are there any vacancies on this clinical trial?

"At this point in time, no additional candidates are being accepted for the study posted on September 3rd 2015. However, if you're keen to explore other trials; 6219 studies recruiting participants with oral squamous cell carcinoma and 1752 clinical trials involving Recombinant EphB4-HSA Fusion Protein are actively accepting patients."

Answered by AI

Has the FDA authorized Recombinant EphB4-HSA Fusion Protein for widespread use?

"Due to its limited safety and efficacy data, Recombinant EphB4-HSA Fusion Protein received a score of 1 on the Power scale."

Answered by AI

How many participants have been enrolled to this trial thus far?

"Unfortunately, the trial is not presently accepting new patients. First posted on September 3rd 2015 and recently updated August 5th 2022, no more participants can be enrolled in this particular study at present. For those searching for other trials related to oral squamous cell carcinoma there are 6219 active studies while 1752 are recruiting patients for Recombinant EphB4-HSA Fusion Protein treatments."

Answered by AI
~6 spots leftby Mar 2025