Clinical Study of Personalized Chemotherapy for Breast Cancer With Low Doses of Cyclophosphamide, Taking Into Account the Reparative Cycle of Tumor Cells

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Russian Federation
Karanahan Llc
RECRUITING
Novosibirsk
Contact Information
Primary
Anastasia Proskurina
labmolbiol@mail.ru
+7-913-715-6920
Time Frame
Start Date: 2018-11-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 20
Treatments
Experimental: Karanahan
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.
Related Therapeutic Areas
Sponsors
Leads: KARANAHAN

This content was sourced from clinicaltrials.gov