Solid Tumor Cancer
Conditions
Keywords
Duffy-null
Brief summary
The goal of this clinical trial is to: * In Phase 1 (observational) to develop an algorithm for treatment of Duffy-null positive patients for chemotherapy dosing * In Phase 2 (interventional), use the algorithm created in phase 1 to adjust chemotherapy dosing for Duffy-null patients
Interventions
DRUGStandard of Care chemotherapy Following an Algorithm
Standard of care chemotherapy for solid tumor malignancies with dose adjustment according to the algorithm produced in phase 1 for Duffy-null positive patients
DRUGStandard of Care chemotherapy following CTCAE criteria
Standard of care chemotherapy for solid tumor malignancies with dose modifications and delays according to the standard of care using CTCAE criteria.
Sponsors
Barbara Ann Karmanos Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Participant must self-identify as being of Middle Eastern or African descent. * Participant must be diagnosed with histologically or cytologically confirmed solid organ cancer and be treatment naive. * Melanoma is allowed; sarcoma is not eligible. * Secondary malignancies are allowed. * Participants who have received only surgery alone as treatment are eligible * Participant must be between the ages of 18-80. * Participant or their legally authorized representative (LAR) must be able to understand a written informed consent document and be willing to sign it.
Exclusion criteria
* Participants with active and uncontrolled bacterial, viral, or fungal infection requiring IV antibiotics. • Participants may be eligible for the study if the infection is deemed to be under control per investigator's discretion. * Participants who have ever received cytotoxic chemotherapy. • Those who have already started a chemotherapy regimen with moderate likelihood of developing neutropenia will be considered for enrollment at the principal investigator's discretion. * Participants who are receiving concurrent chemo-radiation treatment. * Participants who are taking any other investigational drugs. * Participants who are pregnant or breastfeeding. * Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to follow the treatment plan.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of Duffy-null and non-Duffy-null participants who receive chemotherapy RDI <85% | 5 months after the start of chemotherapy | The proportion of patients with chemotherapy RDI (relative dose intensity) \<85% will be estimated separately for the Duffy-null and non-Duffy-null groups. The primary measure of interest is the absolute between-group difference in proportions. A one-sided 90% confidence interval (equivalently, a two-sided 80% confidence interval) will be constructed for this difference. Results will be interpreted relative to the prespecified clinically meaningful threshold of 15% to inform the go/no-go decision for Phase 2. Formal hypothesis testing will be conducted using a one-sided significance level of 10% based on Fisher's exact test. |
| The proportion of Duffy-null and non-Duffy-null participants who receive chemotherapy RDI (relative dose intensity) <85% after implementation of a new purposed algorithm from Phase 1. | 5 months after the start of chemotherapy | The absolute difference in the proportion of patients with chemotherapy RDI \<85% between the Duffy-null group treated under the purposed dosing algorithm and the non-Duffy-null group treated under standard of care will be estimated. A non-inferiority analysis will be performed using a prespecified margin of 7.5%. A two-sided 80% confidence interval (equivalently, a one-sided 90% confidence interval) will be constructed, and non-inferiority will be concluded if the upper bound of the confidence interval is less than 7.5%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rates of fever, infection, hospitalization, and treatment-related mortality in the first five months of chemotherapy treatment | 5 months after the start of chemotherapy | Data will be collected at baseline and up until 4 months after the start of chemotherapy, as well as an additional one month in order to assess treatment-related neutropenia and risks associated with therapy. Incidence of neutropenic fever, infection, hospitalization, and treatment-related mortality within the first five months of chemotherapy will be summarized descriptively within each group. Incidence proportions and corresponding two-sided 95% confidence intervals will be reported. Longitudinal patterns of neutrophil counts will be compared between the Duffy-null and non-Duffy-null groups using appropriate longitudinal methods such as mixed-effects models. In addition, exploratory time-to-first-event analyses for neutropenic fever, infection, hospitalization, and treatment-related mortality may be conducted using Cox proportional hazards models adjusted for relevant confounders (e.g., age, cancer type), and will be considered supportive of the descriptive incidence summaries. |
Countries
United States
Contacts
CONTACTVijendra Singh, M.D.
PRINCIPAL_INVESTIGATORVijendra Singh, M.D.
Barbara Ann Karmanos Cancer Institute
Outcome results
None listed