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Dose Escalating Trial of Mistletoe Extract in Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT03051477
Recruitment Status : Recruiting
First Posted : February 13, 2017
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief 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.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: Helixor® M Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalating Trial of Mistletoe Extract in Patients With Advanced Solid Tumors
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
Experimental: Helixor® M
Advanced solid tumors
Drug: Helixor® M
3-hour IV infusion on Monday, Wednesday, and Friday of each week.
Other Name: Mistletoe extract




Primary Outcome Measures :
  1. Number of participants experiencing toxicities [ Time Frame: 3 years ]
    Number of participants who experience side effects

  2. Maximum tolerated dose (MTD) [ Time Frame: 2 years ]
    The highest dose that does not cause unacceptable side effects


Secondary Outcome Measures :
  1. Tumor marker kinetics [ Time Frame: 3 years ]
    Changes in disease specific bio markers: analyzed as percent change and presented in a waterfall plot of response.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with advanced solid tumors who have had at least one line of therapy for metastatic disease (chemotherapy, immunotherapy, hormonal therapy or other standard treatment)
  2. Have measurable disease
  3. ECOG Performance Status of 0 to 2
  4. Adequate organ function as defined by study-specified laboratory tests
  5. Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
  6. Signed informed consent form
  7. Willing and able to comply with study procedures

Exclusion Criteria:

  1. Patient with a known history or evidence of brain metastases
  2. Patient who has had chemotherapy, radiation, hormonal, or biological cancer therapy within 28 days prior to the first dose of study drug
  3. 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
  4. 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
  5. Patient is expected to require any other form of systemic or localized antineoplastic therapy while on study
  6. Patient who has had any prior treatment with Mistletoe (injection or infusion)
  7. Patients who have received systemic corticosteroids within 28 days prior to the first dose of study drug
  8. Patients who have received systemic NSAID therapy within 14 days prior to the first dose of study drug
  9. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Mistletoe
  10. 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
  11. 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
  12. 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.
  13. Women with a positive pregnancy test on enrollment or prior to investigational product administration
  14. Women who are pregnant or breastfeeding
  15. Sexually active fertile men not using effective birth control if their partners are of child bearing potential
  16. Patient is unwilling or unable to comply with study procedures and/ or schedule.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051477


Contacts
Contact: Denise Gallagher, RN 410-502-5140 phase1trials@exchange.johnshopkins.edu

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Denise Gallagher, RN       phase1trials@exchange.johnshopkins.edu   
Principal Investigator: Channing Paller, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
Principal Investigator: Channing Paller, MD Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03051477     History of Changes
Other Study ID Numbers: J1681
IRB00090991 ( Other Identifier: JHMIRB )
Helixor ( Other Identifier: Helixor Heilmittel GmbH & Co. KG. )
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Viscum album peptide
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents