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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT03051477
First received: February 2, 2017
Last updated: March 6, 2017
Last verified: March 2017
  Purpose
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 Intervention Phase
Solid Tumor
Drug: Helixor® M
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase I Dose Escalating Trial of Mistletoe Extract in Patients With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

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

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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 58
Actual Study Start Date: March 1, 2017
Estimated Study Completion Date: February 2021
Estimated Primary Completion Date: February 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Helixor® M
Advanced solid tumors
Drug: Helixor® M
3 hour IV infusion on Mon, Wed, and Fri each week.
Other Name: Mistletoe extract

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.
  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03051477

Contacts
Contact: Kathy Elza-Brown, RN phase1trials@jhmi.edu

Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287
Contact: Kathy Elza-Brown, RN       phase1trials@jhmi.edu   
Principal Investigator: Channing Paller, MD         
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Principal Investigator: Channing Paller, MD Sidney Kimmel Comprehensive Cancer Center
  More Information

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03051477     History of Changes
Other Study ID Numbers: J1681
Helixor ( Other Identifier: Helixor Heilmittel GmbH & Co. KG. )
IRB00090991 ( Other Identifier: JHMIRB )
Study First Received: February 2, 2017
Last Updated: March 6, 2017
Individual Participant Data  
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

ClinicalTrials.gov processed this record on March 23, 2017