Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment With Paclitaxel (Phase II)

Description

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.

Conditions

Anatomic Stage IV Breast Cancer AJCC v8, Chemotherapy-Induced Peripheral Neuropathy, Metastatic Breast Carcinoma

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Study Overview

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Study Details

Study overview

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.

An Early Phase and Phase II Clinical Trial to Evaluate Ganglioside-Monosialic Acid (GM1) for Preventing Paclitaxel-Associated Neuropathy

Finding an Effective Dose of GM1 to Reduce or Prevent Neuropathy (Numbness or Weakness) Due to Treatment With Paclitaxel (Phase II)

Condition
Anatomic Stage IV Breast Cancer AJCC v8
Intervention / Treatment

-

Contacts and Locations

Irvine

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care, Irvine, California, United States, 92612

Orange

UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States, 92868

Clearwater

Morton Plant Hospital, Clearwater, Florida, United States, 33756

Saint Petersburg

Saint Anthony's Hospital Cancer Care Center, Saint Petersburg, Florida, United States, 33705

Ankeny

Mission Cancer and Blood - Ankeny, Ankeny, Iowa, United States, 50023

Cedar Rapids

Mercy Hospital, Cedar Rapids, Iowa, United States, 52403

Cedar Rapids

Oncology Associates at Mercy Medical Center, Cedar Rapids, Iowa, United States, 52403

Des Moines

Iowa Methodist Medical Center, Des Moines, Iowa, United States, 50309

Des Moines

Mission Cancer and Blood - Des Moines, Des Moines, Iowa, United States, 50309

Rochester

Mayo Clinic in Rochester, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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
  • * N/A

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alliance for Clinical Trials in Oncology,

Study Record Dates

2030-05-31