Trial Title:
Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment With Paclitaxel (Phase II)
NCT ID:
NCT05751668
Condition:
Anatomic Stage IV Breast Cancer AJCC v8
Chemotherapy-Induced Peripheral Neuropathy
Metastatic Breast Carcinoma
Conditions: Official terms:
Breast Neoplasms
Peripheral Nervous System Diseases
Paclitaxel
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Drug
Intervention name:
Paclitaxel
Description:
Given IV
Arm group label:
Arm I (paclitaxel, GM1)
Arm group label:
Arm II (paclitaxel, placebo)
Other name:
Anzatax
Other name:
Asotax
Other name:
Bristaxol
Intervention type:
Drug
Intervention name:
Monosialotetrahexosylganglioside
Description:
Given IV
Arm group label:
Arm I (paclitaxel, GM1)
Other name:
Ganglioside GM-1
Other name:
GM-1
Other name:
GM1
Other name:
Monosialoanglioside GM1
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary Studies
Arm group label:
Arm I (paclitaxel, GM1)
Arm group label:
Arm II (paclitaxel, placebo)
Intervention type:
Other
Intervention name:
Quality-of-life assessment
Description:
Ancillary Studies
Arm group label:
Arm I (paclitaxel, GM1)
Arm group label:
Arm II (paclitaxel, placebo)
Intervention type:
Drug
Intervention name:
Placebo Administration
Description:
Given IV
Arm group label:
Arm II (paclitaxel, placebo)
Summary:
This phase II trial tests the safety, side effects, and best dose of
monosialotetrahexosylganglioside (GM1) and whether it works in reducing or preventing
chemotherapy-induced peripheral neuropathy (CIPN) in patients with breast cancer that has
spread from where it first started (primary site) to other places in the body
(metastatic) who are receiving treatment with paclitaxel. Chemotherapy drugs, such as
paclitaxel, work in different ways to stop the growth of cancer cells, either by killing
the cells, by stopping them from dividing, or by stopping them from spreading. Exposure
to chemotherapy drugs like paclitaxel may cause a side effect called CIPN, which is a
condition of weakness, numbness, and pain from nerve damage (usually in the hands and
feet). GM1 is a part of the body's natural system that insulates nerves and helps to
protect nerves from damage. Giving GM1 may help reduce or prevent CIPN in breast cancer
patients receiving treatment with paclitaxel.
Detailed description:
PRIMARY OBJECTIVES:
I. To obtain data to further support the safety of increasing
monosialotetrahexosylganglioside (GM1) doses when given on day 1, concomitantly with
paclitaxel. (Early phase) II. To evaluate the preliminary efficacy of GM1 compared with
placebo at preventing paclitaxel-induced peripheral neuropathy sensory symptoms as
measured by the six individual Quality of Life Questionnaire-Chemotherapy-Induced
Peripheral Neuropathy 20 (QLQ-CIPN20) questions that quantify numbness (N), tingling (T),
and pain in the fingers/hands and toes/feet. (Phase II)
SECONDARY OBJECTIVES:
I. To obtain additional data to support the safety of GM1 in the treated population.
(Phase II) II. To obtain data to support that GM1 looks promising for
preventing/decreasing acute paclitaxel pain syndrome as measured by the Acute Pain
Syndrome Questionnaire. (Phase II)
EXPLORATORY OBJECTIVES:
I. Conduct of this clinical trial provides the opportunity to facilitate the better
understanding of the natural history of paclitaxel-induced neuropathy, akin to what is
being examined in a currently active trial, S1714. (Phase II) II. This clinical trial
also provides an opportunity to conduct correlative studies to understand the mechanism
of CIPN and/or identify biomarkers of CIPN or GM1 efficacy. (Phase II) III. To obtain
efficacy data to assess the impact of GM1 on the anti-tumor activity of paclitaxel as
evaluated by progression-free survival and overall survival. (Phase II)
OUTLINE: This is an early phase dose-escalation study of GM1 followed by a phase II
study.
EARLY PHASE: Patients receive GM1 intravenously (IV) over 1 hour either once every 7
days, or once every 7 days for 3 doses followed by one week off, prior to paclitaxel
administration.
PHASE II: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive GM1 IV 1 hour prior to paclitaxel administration and paclitaxel
IV weekly for 12 weeks or 3 weeks on/1 week off for 12 doses.
ARM II: Patients receive placebo IV 1 hour prior to paclitaxel administration and
paclitaxel IV weekly for 12 weeks or 3 weeks on/1 week off for 12 doses.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Documentation of disease: Histologic diagnosis of metastatic breast cancer in women
or men
- Prior treatment- No previous exposure to GM1
- Planned administration of paclitaxel, either given weekly, or weekly 3 weeks on/1
week off, to patients with metastatic cancer at a dose of 80 mg/m^2
- No planned treatment with concurrent immunotherapy
- Score of 1 (none) and/or 2 (a little) on the six individual European Organization
for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QLQ)-
chemotherapy-induced peripheral neuropathy (CIPN)20 questions that quantify numbness
(N), tingling (T), and pain in the fingers/hands and toes/feet (Items #31-36)
- No diagnosis of fibromyalgia
- No history of significant respiratory tract infection and/or infectious diarrhea
within 14 days before registration
- No history of stroke or cerebrovascular accident in the past 6 months prior to
registration
- No history of diagnosed neurologic or psychiatric disorders, including epilepsy or
dementia
- For women of childbearing potential, not pregnant and not nursing, because this
study involves an investigational agent whose genotoxic, mutagenic and teratogenic
effects on the developing fetus and newborn are unknown.
Therefore, for women of childbearing potential, a negative pregnancy test done =< 7 days
prior to registration is required. Of note, a female of childbearing potential is a
sexually mature female who: 1) has not undergone a hysterectomy or bilateral
oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive
months (i.e., has had menses at any time in the preceding 12 consecutive months)
- Ability to complete questionnaires by themselves or with assistance
- In order to complete the mandatory patient-completed measures, participants must be
able to speak and/or read English and/or Spanish
- Persons with impaired decision making such that they cannot understand the benefits
or risks of trial participation, per the judgement of the consenting clinician, will
not be eligible
- Age >= 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Absolute neutrophil count (ANC) >= 1,000/mm^3
- Platelet count >= 100,000/mm^3
- Creatinine =< 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 2.5 x upper
limit of normal (ULN)
- Total bilirubin =< 1.5 x ULN
- No planned use of duloxetine
- No planned use of cryotherapy, compression therapy, or cryocompression therapy at
study entry
Exclusion Criteria:
- N/A
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
Address:
City:
Irvine
Zip:
92612
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-827-8839
Email:
ucstudy@uci.edu
Investigator:
Last name:
Ritesh Parajuli
Email:
Principal Investigator
Facility:
Name:
UC Irvine Health/Chao Family Comprehensive Cancer Center
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-827-8839
Email:
ucstudy@uci.edu
Investigator:
Last name:
Ritesh Parajuli
Email:
Principal Investigator
Facility:
Name:
Morton Plant Hospital
Address:
City:
Clearwater
Zip:
33756
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
855-314-8646
Investigator:
Last name:
Vijaya K. Gadiyaram
Email:
Principal Investigator
Facility:
Name:
Saint Anthony's Hospital Cancer Care Center
Address:
City:
Saint Petersburg
Zip:
33705
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
727-825-1113
Email:
Mindy.Thacker@baycare.org
Investigator:
Last name:
Vijaya K. Gadiyaram
Email:
Principal Investigator
Facility:
Name:
Mission Cancer and Blood - Ankeny
Address:
City:
Ankeny
Zip:
50023
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-282-2921
Investigator:
Last name:
Seema Harichand-Herdt
Email:
Principal Investigator
Facility:
Name:
Mercy Hospital
Address:
City:
Cedar Rapids
Zip:
52403
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
319-365-4673
Investigator:
Last name:
Deborah W. Wilbur
Email:
Principal Investigator
Facility:
Name:
Oncology Associates at Mercy Medical Center
Address:
City:
Cedar Rapids
Zip:
52403
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
319-363-2690
Investigator:
Last name:
Deborah W. Wilbur
Email:
Principal Investigator
Facility:
Name:
Iowa Methodist Medical Center
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-241-6727
Investigator:
Last name:
Seema Harichand-Herdt
Email:
Principal Investigator
Facility:
Name:
Mission Cancer and Blood - Des Moines
Address:
City:
Des Moines
Zip:
50309
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
515-241-3305
Investigator:
Last name:
Seema Harichand-Herdt
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
855-776-0015
Investigator:
Last name:
Elizabeth Cathcart-Rake
Email:
Principal Investigator
Facility:
Name:
Coborn Cancer Center at Saint Cloud Hospital
Address:
City:
Saint Cloud
Zip:
56303
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
877-229-4907
Email:
coborncancercenter@centracare.com
Investigator:
Last name:
Donald J. Jurgens
Email:
Principal Investigator
Facility:
Name:
Saint Luke's Hospital
Address:
City:
Chesterfield
Zip:
63017
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
314-205-6936
Investigator:
Last name:
Joseph Sokhn
Email:
Principal Investigator
Facility:
Name:
Southeastern Medical Oncology Center-Clinton
Address:
City:
Clinton
Zip:
28328
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
919-587-9084
Email:
jfields@cancersmoc.com
Investigator:
Last name:
Samer S. Kasbari
Email:
Principal Investigator
Facility:
Name:
Southeastern Medical Oncology Center-Goldsboro
Address:
City:
Goldsboro
Zip:
27534
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
919-587-9084
Email:
jfields@cancersmoc.com
Investigator:
Last name:
Samer S. Kasbari
Email:
Principal Investigator
Facility:
Name:
Southeastern Medical Oncology Center-Jacksonville
Address:
City:
Jacksonville
Zip:
28546
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
910-587-9084
Email:
jfields@cancersmoc.com
Investigator:
Last name:
Samer S. Kasbari
Email:
Principal Investigator
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-293-5066
Email:
Jamesline@osumc.edu
Investigator:
Last name:
Ashley P. Davenport
Email:
Principal Investigator
Facility:
Name:
Toledo Clinic Cancer Centers-Toledo
Address:
City:
Toledo
Zip:
43623
Country:
United States
Status:
Suspended
Facility:
Name:
University of Oklahoma Health Sciences Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
405-271-8777
Email:
ou-clinical-trials@ouhsc.edu
Investigator:
Last name:
Wajeeha Razaq
Email:
Principal Investigator
Facility:
Name:
Legacy Mount Hood Medical Center
Address:
City:
Gresham
Zip:
97030
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-413-2150
Investigator:
Last name:
Mei Dong
Email:
Principal Investigator
Facility:
Name:
Legacy Good Samaritan Hospital and Medical Center
Address:
City:
Portland
Zip:
97210
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-220-4937
Email:
cancer@lhs.org
Investigator:
Last name:
Mei Dong
Email:
Principal Investigator
Facility:
Name:
Legacy Meridian Park Hospital
Address:
City:
Tualatin
Zip:
97062
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-413-1742
Investigator:
Last name:
Mei Dong
Email:
Principal Investigator
Facility:
Name:
Legacy Cancer Institute Medical Oncology and Day Treatment
Address:
City:
Vancouver
Zip:
98684
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Public Contact
Email:
oncologyresearch@lhs.org
Investigator:
Last name:
Mei Dong
Email:
Principal Investigator
Facility:
Name:
Legacy Salmon Creek Hospital
Address:
City:
Vancouver
Zip:
98686
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-413-2150
Investigator:
Last name:
Mei Dong
Email:
Principal Investigator
Facility:
Name:
Marshfield Medical Center-EC Cancer Center
Address:
City:
Eau Claire
Zip:
54701
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-782-8581
Email:
oncology.clinical.trials@marshfieldresearch.org
Investigator:
Last name:
Patcharin Tanawattanacharoen
Email:
Principal Investigator
Facility:
Name:
Marshfield Medical Center-Marshfield
Address:
City:
Marshfield
Zip:
54449
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-782-8581
Email:
oncology.clinical.trials@marshfieldresearch.org
Investigator:
Last name:
Patcharin Tanawattanacharoen
Email:
Principal Investigator
Facility:
Name:
Marshfield Clinic-Minocqua Center
Address:
City:
Minocqua
Zip:
54548
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-782-8581
Email:
oncology.clinical.trials@marshfieldresearch.org
Investigator:
Last name:
Patcharin Tanawattanacharoen
Email:
Principal Investigator
Facility:
Name:
Marshfield Medical Center-River Region at Stevens Point
Address:
City:
Stevens Point
Zip:
54482
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-782-8581
Email:
oncology.clinical.trials@marshfieldresearch.org
Investigator:
Last name:
Patcharin Tanawattanacharoen
Email:
Principal Investigator
Facility:
Name:
Marshfield Medical Center - Weston
Address:
City:
Weston
Zip:
54476
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-782-8581
Email:
oncology.clinical.trials@marshfieldresearch.org
Investigator:
Last name:
Patcharin Tanawattanacharoen
Email:
Principal Investigator
Start date:
November 2, 2023
Completion date:
May 31, 2030
Lead sponsor:
Agency:
Alliance for Clinical Trials in Oncology
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Alliance for Clinical Trials in Oncology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05751668
