Clinical Study of Personalized Chemotherapy for Breast Cancer With Low Doses of Cyclophosphamide

NCT06361264 | Recruiting Early Phase 1

• 1 other identifier: Karanahan
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate the safety and clinical efficacy of personalized chemotherapy with low doses of cyclophosphamide administered taking into account the reparative cycle of tumor cells in participants with breast cancer (stage IV or disease progression). The main question it aims to answer is: Does personalized chemotherapy of breast cancer with low doses of cyclophosphamide, taking into account the reparative cycle of tumor cells, lead to a significant reduction in tumor size and improvement in the visual status of controlled tumor foci relative to their initial state? During the preparatory stage, a tumor sample from participant is harvested intraoperatively. The primary culture is obtained from this tumor tissue sample. Repair cycle time is estimated, and the day when tumor cells are synchronized at the cell cycle G2/M phase is identified. The schedule of administering cyclophosphamide and DNAmix complex composite preparation is calculated according to the resulting time points. According to the elaborated regimen, the participant receives 4 intravenous cyclophosphamide injections at the dose of 300 mg/m2 in combination with 4 injections of 1-12 mg of DNAmix administered into prominent tumor nidi and lymph depots. The participant receives from 2 to 6 courses of therapy. The interval between courses is 21 days.

Conditions

Stage IV Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The size of tumor foci

  Estimation of the size and visual condition of controlled tumor foci relative to their initial state. Tumor response assessment using the Response Evaluation Criteria In Solid Tumors (RECIST 1.1).

  2 months

Secondary Outcomes (2)

• The quality of life score

  2 months

• The immunomodulatory effect

  2 months

Study Arms (1)

Karanahan

EXPERIMENTAL

Reparative cycle of tumor cells is assessed at the preliminary stage in in vitro culture. According to the elaborated regimen, the patient receives 4 intravenous cyclophosphamide injections at the dose of 300 mg/m2 in combination with 4 injections of 1-12 mg of DNAmix administered into prominent tumor nidi and lymph depots. The participant receives from 2 to 6 courses of therapy. The interval between courses is 21 days.

Combination Product: Karanahan

Interventions

Karanahan COMBINATION_PRODUCT

During the preparatory stage, a tumor sample from participant is harvested intraoperatively. The primary culture is obtained from this tumor tissue sample. Repair cycle time is estimated, and the day when tumor cells are synchronized at the cell cycle G2/M phase is identified. The schedule of administering cyclophosphamide and DNAmix complex composite preparation is calculated according to the resulting time points. According to the elaborated regimen, the participant receives 4 intravenous cyclophosphamide injections at the dose of 300 mg/m2 in combination with 4 injections of 1-12 mg of DNAmix administered into prominent tumor nidi and lymph depots. The participant receives from 2 to 6 courses of therapy. The interval between courses is 21 days.

Karanahan

Eligibility Criteria

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

You may qualify if:

• stage IV breast cancer or progression of the disease with the presence of foci accessible for biopsy of tumor material;
• complete awareness of the patient about the prognosis of the disease and the proposed treatment;
• the volume of tumor material required for vital assessment of the time parameters of the individual reparative cycle of tumor cells must be at least 4 cm3;
• tumor cells transferred to primary culture must be in a state of proliferative activity.

You may not qualify if:

• severe decompensated cardiovascular, respiratory, hepatic, renal failure;
• presence of an acute infectious disease;
• intolerance to cyclophosphamide;
• severe neutropenia - the content of neutrophils is less than 1000 per 1 μl of blood;
• simultaneous participation in another clinical trial.

Sponsors & Collaborators

• KARANAHAN: lead

Study Sites (1)

Karanahan Llc

Novosibirsk, Novosibirsk Oblast, 630090, Russia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Anastasia Proskurina

CONTACT

+7-913-715-6920; labmolbiol@mail.ru

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 11, 2024
• Study Start: November 1, 2018
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)