Evaluation of Hydroxychloroquine to Prevent CIPN

NCT05689359 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: STUDY00001721
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is being done to research if hydroxychloroquine can prevent chemotherapy induced peripheral neuropathy. Certain chemotherapy drugs, like paclitaxel, are known to cause neuropathy which can impact quality of life. Currently, there are no options for preventing peripheral neuropathy. In addition, there are no useful methods to assess peripheral nerve damage. This study will also explore using a study MRI of patients' feet prior to starting chemotherapy and after they have completed chemotherapy to see if there is any difference in their nerve structure.

Conditions

Breast Cancer; Gynecologic Cancer; Early-stage Breast Cancer; Peripheral Neuropathy; Chemotherapy-induced Peripheral Neuropathy

Keywords

Chemotherapy Induced Peripheral Neuropathy; Hydroxycloroquine; Diffusion Tensor Imaging; Breast Cancer; Gynecologic Cancer; Paclitaxel; Neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• Symptomatic CIPN

  The primary endpoint is symptomatic CIPN defined as increase in in FACT-GOG/Ntx-12 questionnaire score of greater than or equal to 3 points post-chemotherapy with hydroxychloroquine in combination with paclitaxel chemotherapy in patients with early-stage breast cancer or gynecologic malignancies.

  Throughout study completion, an average of 6 months

Secondary Outcomes (4)

• Predicting Symptomatic CIPN: FA and ADC values derived from DTI

  Baseline

• Predicting Symptomatic CIPN: change in FA and ADC

  Baseline and 12 weeks

• Predicting Symptomatic CIPN: baseline NF-L levels

  Baseline

• Predicting Symptomatic CIPN: Changes in NF-L levels

  Baseline and 12 weeks

Study Arms (1)

Addition of Hydroxychloroquine to paclitaxel

EXPERIMENTAL

Hydroxychloroquine will be added to chemotherapy in patients with early stage (1-3) breast cancer and gynecological cancers.

Drug: Hydroxychloroquine

Interventions

Hydroxychloroquine DRUG

Hydroxychloroquine will be administered at 600 mg po BID for 3 days prior to starting chemotherapy, continued during the course of chemotherapy, and for 7 days after chemotherapy.

Addition of Hydroxychloroquine to paclitaxel

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with stage 1-3 breast cancer or gynecological cancer treated with curative intent
• Age ≥ 21 years old
• No prior neurotoxic chemotherapies
• No other neurotoxic chemotherapies planned during paclitaxel treatment (i.e, platinum)
• Need to be treated with paclitaxel weekly x 12 doses as determined by their treating physician
• Be able to undergo MR Imaging
• Be willing to comply with scheduled visits, treatment plan, and MR imaging
• Adequate organ function as defined as:
• Hematologic:
• Absolute neutrophil count (ANC) ≥ 1500/mm3 Platelet count ≥ 100,000/mm3 Hemoglobin ≥ 9 g/dL
• Hepatic:
• Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
• Renal:
• Estimated creatinine clearance (CrCl)≥ 50 mL/min by Cockcroft-Gault formula

You may not qualify if:

• Stage IV cancer
• CTCAE neurological function \> grade 1 at baseline
• Mental limitation that precludes understanding of or completion of questionnaires
• History of diabetes or other neurological disorders
• Preexisting peripheral neuropathy
• Prior exposure to neurotoxic chemotherapy
• Currently taking medication to treat or prevent neuropathy
• Have non-MRI compatible metallic objects on/in body
• Have metallic hardware in the lower extremity which is MR compatible however would create too much artifact for MR examination
• Pregnant or lactating patients. Women of childbearing potential and sexually active men must use an effective contraception method during rreatment and for three months after completing treatment. Patients of childbearing potential must have a negative serum or urine B-hCG pregnancy test at screening.
• History or current evidence of central serous retinopathy (CSR) or retinal vein occlusion (RVO) or current risk factors for RVO (e.g. uncontrolled glaucoma or ocular hypertension, history of hyperviscosity) or macular degeneration.
• QTc prolongation defined as a QTcF \> 500 ms
• Known glucose-6-phosphate dehydrogenase (G-6-PD) deficiency.

Sponsors & Collaborators

• University of Arizona: lead

MeSH Terms

Conditions

Breast Neoplasms; Peripheral Nervous System Diseases

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jennifer Segar, MD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: January 19, 2023
• Study Start: June 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share