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Solid TumorPhase 1NCT03051477

Trial of Mistletoe Extract in Patients With Advanced Solid Tumors

A Phase 1 study testing Helixor® M in people with Solid Tumor, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will seek to determine the safety and toxicity profile as well as the maximum tolerated dose of Helixor® M in patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Solid Tumor
What is being tested?
Helixor® M
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
1 Mar 2017to 5 Aug 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with advanced solid tumors and have received first line standard systemic therapy with chemotherapy, immunotherapy, hormonal therapy or other standard treatments for metastatic disease. Patients must either have progressed, are refractory, have stable disease and/or removed from therapy due to toxicities. Patients beyond first line therapy that do not meet criteria may be considered on a case by case basis and allowed at discretion of PI.
  • Patients with the presence of at least one measurable lesion as defined by RECIST 1.1 criteria for response assessment. Prostate cancer patients with bone disease only are eligible.
  • Age >18 years.
  • ECOG performance status 0-2
  • Life expectancy of greater than 3 months.
  • Patients must have normal organ and marrow function as defined below (without growth factor or transfusion support within 14 days prior to first dose of investigational product):
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  • WBC ≥ 3,000/mcL
  • Absolute neutrophil count ≥ 1,000/mcL
  • Platelets ≥ 90,000/mcL
  • Hemoglobin ≥ 9.0 g/dL
  • Total bilirubin ≤ 1.5 X ULN (patients with diagnosed Gilbert's Syndrome will not be excluded if their direct bilirubin is within normal institutional limits)
  • AST(SGOT)/ALT(SGPT) ≤ 2.5 X ULN
  • Creatinine ≤1.5 x ULN OR creatinine clearance ≥ 50 mL/min/1.73 m2
  • Female patient of childbearing potential has a negative urine or serum pregnancy test. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. The serum pregnancy test must be negative for the patient to be eligible.
  • Female patients enrolled in the study, who are not free from menses for >2 years, post hysterectomy / oophorectomy, or surgically sterilized, must be willing to use either 2 adequate barrier methods or a barrier method plus a hormonal method of contraception to prevent pregnancy or to abstain from heterosexual activity throughout the study, starting with Visit 1 through 28 days after the last dose of study therapy. Approved contraceptive methods include for example; intra uterine device, diaphragm with spermicide, cervical cap with spermicide, male condoms, female condoms with spermicide, or oral contraceptives. Spermicides alone are not an acceptable method of contraception.
  • -- Male patients must agree to use an adequate method of contraception starting with the first dose of study drug through 28 days after the last dose of study therapy.
  • Ability to understand and the willingness to sign a written informed consent document.

Who cannot join

  • Patient with a known history or evidence of brain metastases.
  • Patients who have had chemotherapy, radiation, hormonal, or biological cancer therapy within 28 days prior to the first dose of study drug excluding patients on long term hormonal therapies who have been on a stable dose for at least 3 months.
  • Patient is currently participating or has participated in a study of an investigational agent or using an investigational device within 28 days of the first dose of study drug.
  • Patients who have had surgery within 28 days of dosing of investigational agent, excluding minor procedures (dental work, skin biopsy, etc), celiac plexus block, and biliary stent placement.
  • Patient is expected to require any other form of systemic or localized antineoplastic therapy while on study.
  • Patient who has had prior treatment with Mistletoe.
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  • Patients who have received systemic corticosteroids within 28 days prior to the first dose of study drug. Note: Systemic steroid therapy is allowed for subjects on replacement therapy as long as prednisone ≤ 10 mg or its steroid equivalent.
  • Patients who have received systemic NSAID therapy within 14 days prior to the first dose of study drug.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Mistletoe.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Presence of ≥ CTCAE grade 2 toxicity (except peripheral neuropathy and ototoxicity, which are excluded if ≥ CTCAE grade 3) due to prior cancer therapy.
  • Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's Disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and Myasthenia Gravis, multiple sclerosis). History of Grave's disease on stable thyroid hormone replacement for at least 1 year is allowed.
  • Patients with a known history of HIV, hepatitis B, hepatitis C, or tuberculosis infection. Patients with a history of cleared hepatitis C (undetectable viral loads) are allowed.
  • Women with a positive pregnancy test on enrollment or prior to investigational product administration
  • Women who are pregnant or breastfeeding.
  • Sexually active fertile men not using effective birth control if their partners are of child bearing potential.
  • Patient is unwilling or unable to comply with study procedures.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: A Phase I Dose Escalating Trial of Mistletoe Extract in Patients With Advanced Solid Tumors

This study will seek to determine the safety and toxicity profile as well as the maximum tolerated dose of Helixor® M in patients with advanced solid tumors.

Read the detailed description

This study is a Phase I study that consists of two phases: a dose escalation phase and an expansion phase. The dose escalation phase will be used to evaluate the safety and toxicity of Helixor® M (mistletoe extract). An accelerated titration design (ATD) will be utilized to determine the MTD. The expansion phase will be used to obtain preliminary efficacy data about Helixor® M.

Conditions
Solid Tumor
Being tested
Helixor® M

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Helixor® MDrug

    Also called Mistletoe extract

    3-hour IV infusion on Monday, Wednesday, and Friday of each week.

Study groups in NCT03051477
Study groupRoleWhat they receive
Helixor® MExperimentalAdvanced solid tumors
Receives: Drug: Helixor® M

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants experiencing toxicities

    Number of participants who experience side effects

    Measured: 3 years

  2. Maximum tolerated dose (MTD)

    The highest dose that does not cause unacceptable side effects

    Measured: 2 years

Secondary outcomes (1)

  1. Tumor marker kinetics

    Changes in disease specific bio markers: analyzed as percent change and presented in a waterfall plot of response.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2017
  2. Study start1 Mar 2017
  3. Primary completion29 Jan 2021
  4. Study completion5 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03051477
Sponsor's protocol ID
J1681
Other IDs
IRB00090991, Helixor
Status last verified
Dec 2022
First submitted
2 Feb 2017
Last updated
8 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Helixor® M in people with Solid Tumor, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants experiencing toxicities (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03051477.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2022.

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