- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05751668
Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment With Paclitaxel (Phase II)
An Early Phase and Phase II Clinical Trial to Evaluate Ganglioside-Monosialic Acid (GM1) for Preventing Paclitaxel-Associated Neuropathy
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Elizabeth Cathcart-Rake, MD
- Phone Number: 507-768-4411
- Email: Cathcart-Rake.Elizabeth@mayo.edu
Study Contact Backup
- Name: Aishwarya Vijendran
- Phone Number: 773-834-9613
- Email: aishwaryav@bsd.uchicago.edu
Study Locations
-
-
Florida
-
Clearwater, Florida, United States, 33756
- Recruiting
- Morton Plant Hospital
-
Contact:
- Site Public Contact
- Phone Number: 855-314-8646
-
Principal Investigator:
- Vijaya K. Gadiyaram
-
Saint Petersburg, Florida, United States, 33705
- Recruiting
- Saint Anthony's Hospital Cancer Care Center
-
Principal Investigator:
- Vijaya K. Gadiyaram
-
Contact:
- Site Public Contact
- Phone Number: 727-825-1113
- Email: Mindy.Thacker@baycare.org
-
-
Iowa
-
Cedar Rapids, Iowa, United States, 52403
- Recruiting
- Mercy Hospital
-
Contact:
- Site Public Contact
- Phone Number: 319-365-4673
-
Principal Investigator:
- Deborah W. Wilbur
-
Cedar Rapids, Iowa, United States, 52403
- Recruiting
- Oncology Associates at Mercy Medical Center
-
Principal Investigator:
- Deborah W. Wilbur
-
Contact:
- Site Public Contact
- Phone Number: 319-363-2690
-
Des Moines, Iowa, United States, 50309
- Recruiting
- Medical Oncology and Hematology Associates-Des Moines
-
Principal Investigator:
- Joshua Lukenbill
-
Contact:
- Site Public Contact
- Phone Number: 515-241-3305
-
Des Moines, Iowa, United States, 50309
- Recruiting
- Iowa Methodist Medical Center
-
Principal Investigator:
- Joshua Lukenbill
-
Contact:
- Site Public Contact
- Phone Number: 515-241-6727
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
Contact:
- Site Public Contact
- Phone Number: 855-776-0015
-
Principal Investigator:
- Elizabeth Cathcart-Rake
-
Saint Cloud, Minnesota, United States, 56303
- Recruiting
- Coborn Cancer Center at Saint Cloud Hospital
-
Contact:
- Site Public Contact
- Phone Number: 877-229-4907
- Email: coborncancercenter@centracare.com
-
Principal Investigator:
- Donald J. Jurgens
-
-
Missouri
-
Chesterfield, Missouri, United States, 63017
- Recruiting
- Saint Luke's Hospital
-
Contact:
- Site Public Contact
- Phone Number: 314-205-6936
-
Principal Investigator:
- Joseph Sokhn
-
-
North Carolina
-
Clinton, North Carolina, United States, 28328
- Recruiting
- Southeastern Medical Oncology Center-Clinton
-
Contact:
- Site Public Contact
- Phone Number: 919-587-9084
- Email: jfields@cancersmoc.com
-
Principal Investigator:
- Samer S. Kasbari
-
Goldsboro, North Carolina, United States, 27534
- Recruiting
- Southeastern Medical Oncology Center-Goldsboro
-
Contact:
- Site Public Contact
- Phone Number: 919-587-9084
- Email: jfields@cancersmoc.com
-
Principal Investigator:
- Samer S. Kasbari
-
Jacksonville, North Carolina, United States, 28546
- Recruiting
- Southeastern Medical Oncology Center-Jacksonville
-
Principal Investigator:
- Samer S. Kasbari
-
Contact:
- Site Public Contact
- Phone Number: 910-587-9084
- Email: jfields@cancersmoc.com
-
-
Ohio
-
Toledo, Ohio, United States, 43623
- Recruiting
- Toledo Clinic Cancer Centers-Toledo
-
Principal Investigator:
- Rex B. Mowat
-
Contact:
- Site Public Contact
- Phone Number: 800-444-3561
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73104
- Recruiting
- University of Oklahoma Health Sciences Center
-
Contact:
- Site Public Contact
- Phone Number: 405-271-8777
- Email: ou-clinical-trials@ouhsc.edu
-
Principal Investigator:
- Wajeeha Razaq
-
-
Oregon
-
Gresham, Oregon, United States, 97030
- Not yet recruiting
- Legacy Mount Hood Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 503-413-2150
-
Principal Investigator:
- Mei Dong
-
Portland, Oregon, United States, 97210
- Not yet recruiting
- Legacy Good Samaritan Hospital and Medical Center
-
Principal Investigator:
- Mei Dong
-
Contact:
- Site Public Contact
- Phone Number: 800-220-4937
- Email: cancer@lhs.org
-
Tualatin, Oregon, United States, 97062
- Not yet recruiting
- Legacy Meridian Park Hospital
-
Principal Investigator:
- Mei Dong
-
Contact:
- Site Public Contact
- Phone Number: 503-413-1742
-
-
Washington
-
Vancouver, Washington, United States, 98686
- Not yet recruiting
- Legacy Salmon Creek Hospital
-
Contact:
- Site Public Contact
- Phone Number: 503-413-2150
-
Principal Investigator:
- Mei Dong
-
Vancouver, Washington, United States, 98684
- Not yet recruiting
- Legacy Cancer Institute Medical Oncology and Day Treatment
-
Principal Investigator:
- Mei Dong
-
Contact:
- Site Public Contact
- Email: oncologyresearch@lhs.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm I (paclitaxel, GM1)
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.
|
Given IV
Other Names:
Ancillary Studies
Given IV
Other Names:
Ancillary Studies
|
Placebo Comparator: Arm II (paclitaxel, placebo)
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.
|
Given IV
Other Names:
Ancillary Studies
Given IV
Ancillary Studies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Tolerated Dose (Early phase)
Time Frame: 6-7 months
|
Defined as the highest dose level that induces dose-limiting toxicity in less than one-third of patients (less than 1 out of 3 or less than 2 out of a maximum of 6 new patients).The constellation of adverse events as scored using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events, version (v) 5.0 (CTCAE v5.0) will be summarized by reporting the number and percentage of patients.
Specifically, the number and severity of all adverse events (overall and by dose-level) will be tabulated and summarized.
The grade 3+ adverse events will also be described and summarized in a similar fashion.
Further, all adverse events will be listed by system organ class and preferred term.
|
6-7 months
|
Composite response (Phase II)
Time Frame: Up to one year
|
Reflects sensory paclitaxel-induced peripheral neuropathy symptom severity and onset.
Measured using 6 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.
Will calculate the highest (worst) N, T, and pain sensory score obtained anytime during paclitaxel exposure.
Response is defined as a patient reporting a highest score of =< 2 without discontinuing the study due to sensory paclitaxel-induced peripheral neuropathy.
Chi-squared test will be used.
Will report the proportion of patients achieving a composite response in each arm as well as the difference in proportions along with the 90% confidence interval.
Will report the estimated odds ratio (monosialotetrahexosylganglioside [GM1]/placebo) and the corresponding 90% confidence interval for the true, but unknown odds ratio.
Multiple logistic regression will be used to estimate the intervention
|
Up to one year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients who received full planned dose of paclitaxel
Time Frame: up to 1 year
|
Binary endpoint (yes or no).
will graphically look at the percentages of patients receiving full planned paclitaxel doses per cycle within each arm.
This is an indirect measure of paclitaxel-induced peripheral neuropathy, as most patients who stop receiving full dose paclitaxel do so because of paclitaxel-induced peripheral neuropathy troubles.
In addition to graphically displaying the percentage of patients who receive full dose paclitaxel at each cycle, and according to arm, will make a between-arm comparison in terms of changes in the probability of receiving full dose paclitaxel over the 12 cycles of treatment.
For latter analysis, the generalized estimating equations approach will be applied, with inference based on the empirical or sandwich variance estimator.
|
up to 1 year
|
• Sensory subscale of the European Organization of Research and Treatment of Cancer (EORTC) QLQ-CIPN20
Time Frame: Up to 1 year
|
Serially measured.
Item scores are totaled and linearly converted to a 0-100 point scale with higher scores representing fewer symptoms or better quality of life.
Will use the area under the curve (AUC) to summarize the serially measured sensory subscale scores.
Patients will be analyzed in the arms to which they were randomized.
In order to adjust for the stratification factors, the AUC will be computed for the two arms based on estimated parameters from a repeated-measures (means) mixed model.
|
Up to 1 year
|
Rate of grade 3+ Adverse Events
Time Frame: Up to 1 year
|
The proportion of patients experiencing a grade 3+ adverse events or toxicities will be described for each treatment arm, and will also be compared between the arms using Fisher's exact tests.
Additional summaries and test will be performed as needed.
|
Up to 1 year
|
• Serially measured patient-reported outcome that best describes the patients' aches/pains at its worst in the last 24 hours
Time Frame: In the preceding 24 hours
|
Within each arm, the mean score at each time point will be plotted longitudinally for the endpoints measuring aches and pains at its worst.
The functional form of the relationship between time and each of these three patient-reported acute neuropathy items is not known.
Penalized splines, a smoothing technique which does not require strong assumptions concerning the functional form of the pattern of change in the mean response, will be applied to these longitudinal data.
In the two-arm setting (GM1 vs placebo) time trends will be incorporated in a non-parametric fashion, thereby allowing the mean response to change in a highly non-linear, but not predetermined, way.
The intervention effect will be incorporated in the model in a parametric fashion, thereby allowing a relatively simple, but powerful, test of the intervention effect on changes in the mean response over time.
|
In the preceding 24 hours
|
Serially measured patient-reported outcome that best describes the patients' aches/pains at its least in the last 24 hours
Time Frame: in the preceding 24 hours
|
Within each arm, the mean score at each time point will be plotted longitudinally for the endpoints measuring aches and pains at its least.
The functional form of the relationship between time and each of these three patient-reported acute neuropathy items is not known.
Penalized splines, a smoothing technique which does not require strong assumptions concerning the functional form of the pattern of change in the mean response, will be applied to these longitudinal data.
In the two-arm setting (GM1 vs placebo) time trends will be incorporated in a non-parametric fashion, thereby allowing the mean response to change in a highly non-linear, but not predetermined, way.
The intervention effect will be incorporated in the model in a parametric fashion, thereby allowing a relatively simple, but powerful, test of the intervention effect on changes in the mean response over time.
|
in the preceding 24 hours
|
• Serially measured patient-reported outcome that best describes the patients' aches/pains on the average in the last 24 hours
Time Frame: in the preceding 24 hours
|
Within each arm, the mean score at each time point will be plotted longitudinally for the endpoints measuring aches and pains on average.
The functional form of the relationship between time and each of these three patient-reported acute neuropathy items is not known.
Penalized splines, a smoothing technique which does not require strong assumptions concerning the functional form of the pattern of change in the mean response, will be applied to these longitudinal data.
In the two-arm setting (GM1 vs placebo) time trends will be incorporated in a non-parametric fashion, thereby allowing the mean response to change in a highly non-linear, but not predetermined, way.
The intervention effect will be incorporated in the model in a parametric fashion, thereby allowing a relatively simple, but powerful, test of the intervention effect on changes in the mean response over time.
|
in the preceding 24 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression free survival (PFS)
Time Frame: Up to 4 years after the end of GM1 treatment
|
Distributions of PFS times will be estimated using Kaplan-Meier methodology.
|
Up to 4 years after the end of GM1 treatment
|
Overall survival (OS)
Time Frame: Up to 4 years after the end of GM1 treatment
|
Distributions of OS times will be estimated using Kaplan-Meier methodology.
|
Up to 4 years after the end of GM1 treatment
|
Serially measured total score of the EORTC QLQ-CIPN20
Time Frame: On day 1 of each dose prior to GM1, monthly after the end of GM1, at 8, 12, 16, 20, and 24 months after last study treatment
|
Will use the AUC to summarize the serially measured EORTC QLQ-CIPN20 scores.
Patients will be analyzed in the arms to which they were randomized.
In order to adjust for the stratification factors, the AUC will be computed for the two arms based on estimated parameters from a repeated-measures (means) mixed model.
|
On day 1 of each dose prior to GM1, monthly after the end of GM1, at 8, 12, 16, 20, and 24 months after last study treatment
|
Patient-reported severity and interference of numbness or tingling in hands or feet
Time Frame: On day 1 of each dose prior to GM1, monthly after the end of GM1, at 8, 12, 16, 20, and 24 months after last study treatment
|
As measured by the Patient Reported Outcomes version CTCAE (PRO-CTCAE).
The maximum grade for each of these events will be recorded for each patient and frequency tables will be generated and presented according to treatment arm.
The descriptive analysis of the PRO-CTCAE endpoints will be based on the safety population and analyzed according to the treatment actually received.
|
On day 1 of each dose prior to GM1, monthly after the end of GM1, at 8, 12, 16, 20, and 24 months after last study treatment
|
Serially measured patient-reported aggregate scores
Time Frame: On day 1 of each dose prior to GM1, monthly after the end of GM1, at 8, 12, 16, 20, and 24 months after last study treatment
|
Measured by the 11-item Functional Assessment of Cancer Therapy - Gynecologic Oncology Group-Neurotoxicity 4. Will tabulate all available serially measured PROs at each protocol defined time point and within each arm; furthermore, will graphically display the longitudinal PROs over time.
Will compare and contrast the descriptive findings between these CIPN-measuring instruments in this trial and in the corresponding longitudinal data obtained in S1714.
No inferential statistics will be generated.
Further, these descriptive summaries will be used to better understand these instruments.
|
On day 1 of each dose prior to GM1, monthly after the end of GM1, at 8, 12, 16, 20, and 24 months after last study treatment
|
Serially measured patient-reported total score
Time Frame: On day 1 of each dose prior to GM1, monthly after the end of GM1, at 8, 12, 16, 20, and 24 months after last study treatment
|
Measured by the 5-item Patient Reported Outcomes Measurement Information System-Neuropathic Pain Quality scale.
Will tabulate all available serially measured PROs at each protocol defined time point and within each arm; furthermore, will graphically display the longitudinal PROs over time.
Will compare and contrast the descriptive findings between these CIPN-measuring instruments in this trial and in the corresponding longitudinal data obtained in S1714.
No inferential statistics will be generated.
Further, these descriptive summaries will be used to better understand these instruments.
|
On day 1 of each dose prior to GM1, monthly after the end of GM1, at 8, 12, 16, 20, and 24 months after last study treatment
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Neuromuscular Diseases
- Breast Neoplasms
- Peripheral Nervous System Diseases
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- A222101
- NCI-2022-04929 (Other Identifier: NCI Clinical Trial Reporting Program)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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