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Trial Title:
Clinical Study of Personalized Chemotherapy for Breast Cancer With Low Doses of Cyclophosphamide
NCT ID:
NCT06361264
Condition:
Stage IV Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Karanahan
Description:
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.
Arm group label:
Karanahan
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Karanahan Llc
Address:
City:
Novosibirsk
Zip:
630090
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Anastasia Proskurina
Email:
labmolbiol@mail.ru
Investigator:
Last name:
Sergey Sidorov
Email:
Principal Investigator
Start date:
November 1, 2018
Completion date:
December 1, 2025
Lead sponsor:
Agency:
KARANAHAN
Agency class:
Other
Source:
KARANAHAN
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06361264
