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

Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · Feb 21, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called GM1 to see if it can help reduce or prevent a painful condition known as chemotherapy-induced peripheral neuropathy (CIPN) in patients with metastatic breast cancer who are receiving the chemotherapy drug paclitaxel. CIPN can cause symptoms like numbness and weakness, particularly in the hands and feet, and can be quite uncomfortable for patients undergoing treatment. The researchers want to find out the safest dose of GM1 and whether it can help protect nerves from damage caused by chemotherapy.

To participate in this trial, patients need to be at least 18 years old and have a confirmed diagnosis of metastatic breast cancer. They should not have previously received GM1 and must be planning to start treatment with paclitaxel. Participants will be asked to fill out some questionnaires about their symptoms and quality of life, and they will be monitored for any side effects from the treatment. It's important for potential participants to understand that this study is looking for ways to improve their comfort during chemotherapy, and their involvement could help others in the future.

Gender

ALL

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