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Anti-tumor antibiotic

L-DOS47 + Doxorubicin for Pancreatic Cancer

Phase 1 & 2

Recruiting

Led By Erkut Borazanci, MD

Research Sponsored by Helix BioPharma Corporation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

One or more metastatic tumors measurable on computed tomography (CT) scan per RECIST version 1.1 and screening FDG-PET scan with maximum standardized uptake value (SUV max) ≥ 5.5 for at least one lesion consistent with pancreatic cancer

Acceptable renal function as defined by creatinine ≤1.5x institutional upper limits of normal, or calculated creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening to end of cycle 2, where each treatment cycle is 28 days.

Awards & highlights

Study Summary

This trial will test a new combination therapy for advanced pancreatic cancer. The goal is to see if it is safe and better than current treatments.

Who is the study for?

Adults with advanced pancreatic cancer who've had prior treatment can join. They need normal kidney, liver, and blood function, no serious heart issues or infections, and a life expectancy of at least 3 months. Participants must not be pregnant or nursing and agree to use contraception.Check my eligibility

What is being tested?

The trial tests L-DOS47 combined with doxorubicin on patients with advanced pancreatic cancer to check safety, tolerability, and initial effectiveness against tumors measurable by scans.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system due to L-DOS47 and heart problems, nausea, hair loss from Doxorubicin. Specific side effects will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have at least one tumor from pancreatic cancer that shows up on scans and is active.

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My kidney function is within the required range.

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I am able to care for myself but may not be able to do active work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening to end of cycle 2, where each treatment cycle is 28 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening to end of cycle 2, where each treatment cycle is 28 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening to end of cycle 2, where each treatment cycle is 28 days. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse events (as per CTCAE v. 5.0)

Number of complete plus partial responders as per RECIST version 1.1

Secondary outcome measures

Carbohydrate antigen (CA) 19-9 biomarker level

Body Weight Changes

Proportion of patients expressing anti-L-DOS47 antibodies

Side effects data

From 2015 Phase 2 trial • 32 Patients • NCT01205503

47%

Anemia

41%

Nausea

31%

Lymphocyte count decreased

28%

Fatigue

28%

White blood cell decreased

28%

Neutrophil count decreased

13%

Platelet count decreased

13%

Headache

13%

Hypoatremia

13%

Constipation

13%

Paresthesia

Cough

Alanine aminotransferase increased

Hypocalcemia

Hypokalemia

Myalgia

Vomiting

Hypoalbuminemia

Dyspnea

Febrile neutropenia

Hypernatremia

Edema Limbs

Mucositis oral

Pain

Chills

Flank Pain

Insomnia

Hemorrhoids

Vaginal Infection

MRSA positive infection in toe

Urinary Frequency

Rash maculo-papular

Diarrhea

Depression

Fibrinogen decreased

Gastritis

Hypomagnesemia

Hypotension

Non-cardiac chest pain

Pain in extremity

Palpitations

Pruritus

Sore Throat

Wheezing

Blurred Vision

Alkaline phosphatase increased

Blood bilirubin increased

Allergic rhinitis

Anorexia

Lung Infection

Arthralgia

Dermatitis

Creatinine increased

Esophageal Spasms

Hyperglycemia

Lip Infection

Muscle weakness upper limb

100%

80%

60%

40%

20%

Study treatment Arm

Saline

Mesna

Trial Design

1Treatment groups

Experimental Treatment

Group I: L-DOS47 + doxorubicinExperimental Treatment2 Interventions

Patients will be recruited into escalating dosing cohorts of 3, 6 and 9 µg/kg of L-DOS47, with a minimum of 3 and a maximum of 6 patients per cohort. A fixed dose of intravenous doxorubicin [20 mg/m2/week] will be administered in combination with L-DOS47 across all cohorts.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

L-DOS47

2014

Completed Phase 2

~90

Doxorubicin

2012

Completed Phase 3

~7940

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

TheradexIndustry Sponsor

33 Previous Clinical Trials

1,552 Total Patients Enrolled

Helix BioPharma CorporationLead Sponsor

3 Previous Clinical Trials

99 Total Patients Enrolled

Erkut Borazanci, MDPrincipal InvestigatorScottsdale Healthcare Hospitals DBA HonorHealth

7 Previous Clinical Trials

383 Total Patients Enrolled

Frequently Asked Questions

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

Are there any precedents of research projects concerning L-DOS47?

"At present, there are 360 research projects in progress that involve L-DOS47. 119 of those initiatives have passed Phase 3 and entered the final testing stage. While most trials for this treatment are conducted in Providence, Rhode island, it is available at 23596 different sites worldwide."

Answered by AI

Is enrollment open for this research project?

"Affirmative. As evidenced by the clinicaltrials.gov database, this medical trial is actively seeking volunteers and has been since its initial posting on December 11th 2019. 20 qualified patients need to be recruited from 3 clinics across the country."

Answered by AI

Is this endeavor the inaugural exploration of its kind?

"Alfacell conducted the first L-DOS47 trial in 1997, which included 300 participants. Subsequently, it attained Phase 3 drug authorization and is currently being investigated across 1941 cities in 66 countries with 360 ongoing studies."

Answered by AI

Could you please provide me with a figure of the participants in this medical trial?

"The trial's sponsor, Helix BioPharma Corporation, must enlist a total of 20 qualified participants to carry out the study. Recruitment efforts will be conducted in Froedtert Hospital and the Medical College of Wisconsin (Milwaukee) as well as Atlantic Health System - Morristown Medical Center (New jersey)."

Answered by AI

What medical conditions do physicians typically utilize L-DOS47 to address?

"L-DOS47 is typically prescribed for lymphoma and hodgkins, but may also be beneficial in managing cancers such as bronchogenic carcinoma, neuroblastoma (nb), and sezary syndrome."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

L-DOS47 Plus Doxorubicin in Advanced Pancreatic Cancer

2019. "L-DOS47 Plus Doxorubicin in Advanced Pancreatic Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04203641.