Chemotherapy Dosing for Cancer

VS
Overseen ByVijendra Singh, M.D.
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Barbara Ann Karmanos Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores new methods to adjust chemotherapy doses for cancer patients with the Duffy-null blood type. In the first phase, researchers will develop a dosing algorithm. In the second phase, they will test its effectiveness in helping patients with this blood type better tolerate chemotherapy. Ideal participants are individuals of Middle Eastern or African descent with newly diagnosed solid organ cancer who have not yet undergone chemotherapy. As a Phase 1 and Phase 2 trial, this research aims to understand how the treatment works and measure its effectiveness, offering participants an opportunity to contribute to groundbreaking advancements in cancer care.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that chemotherapy can be challenging, often causing side effects for many patients. For example, 86% of patients with advanced breast cancer reported significant side effects from their treatment, often leading to dose reductions. Researchers are exploring new ways to manage chemotherapy doses for this reason.

Research also shows that using lower doses of chemotherapy can lead to fewer side effects and a better quality of life, without reducing treatment effectiveness. Adjusting the chemotherapy dose aims to balance manageable side effects with effective cancer treatment.

In this trial, one experimental treatment involves adjusting chemotherapy doses using a special method. Previous patients demonstrated that these adjustments can make the treatment easier to handle, resulting in fewer unwanted side effects and a better experience during treatment.

Overall, while chemotherapy can be tough, efforts are underway to improve its administration, reduce side effects, and enhance patient outcomes.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to personalize chemotherapy dosing for cancer patients based on their Duffy-null blood type. Unlike traditional chemotherapy, which often uses a one-size-fits-all approach guided by CTCAE criteria, this trial uses a specialized algorithm to adjust doses specifically for patients with a positive Duffy-null phenotype. This personalized approach aims to optimize treatment effectiveness while minimizing side effects, potentially leading to better outcomes for patients.

What evidence suggests that this trial's treatments could be effective for cancer?

This trial will compare two approaches to chemotherapy dosing. In one arm, patients with a positive Duffy-null blood test will receive standard care chemotherapy with dose adjustments according to an algorithm developed in phase 1 of this study. In the other arm, patients with a negative Duffy-null blood test will receive standard care chemotherapy with delays or modifications based on standard CTCAE grading. Studies have shown that adjusting chemotherapy doses to fit individual patient needs can be effective. One method involves using lower doses of several drugs, which can lessen side effects while maintaining efficacy. Research indicates that low-dose chemotherapy can be as effective as standard doses. Specifically, patients receiving reduced-dose treatments had similar times without cancer progression compared to those on standard doses. This suggests that customizing chemotherapy doses might provide a good balance between treatment effectiveness and quality of life for patients.678910

Who Is on the Research Team?

VS

Vijendra Singh, M.D.

Principal Investigator

Barbara Ann Karmanos Cancer Institute

Are You a Good Fit for This Trial?

This trial is for people with cancer who are Duffy-null positive, a genetic trait more common in individuals of African descent. Participants will be receiving chemotherapy and must meet standard requirements to safely undergo treatment.

Inclusion Criteria

I have a confirmed solid organ cancer and have not started any treatment.
Participant must self-identify as being of Middle Eastern or African descent
I may have another type of cancer besides my main diagnosis.
See 4 more

Exclusion Criteria

Participants who are pregnant or breastfeeding
I am currently receiving both chemotherapy and radiation at the same time.
I am currently taking another investigational drug.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 (Observational)

Develop an algorithm for treatment of Duffy-null positive patients for chemotherapy dosing

5 months

Phase 2 (Interventional)

Use the algorithm created in Phase 1 to adjust chemotherapy dosing for Duffy-null patients

5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Standard of Care Chemotherapy Following an Algorithm
  • Standard of Care Chemotherapy following CTCAE criteria

Trial Overview

The study compares two ways of deciding chemotherapy doses: one uses a new algorithm tailored for Duffy-null patients, the other follows usual guidelines (CTCAE criteria). The goal is to see if personalized dosing improves safety or effectiveness.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Duffy-null phenotype positiveExperimental Treatment1 Intervention
Group II: Non-Duffy-nullActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Barbara Ann Karmanos Cancer Institute

Lead Sponsor

Trials
166
Recruited
9,300+

Citations

Chemotherapy Dose Intensity and Quality Cancer Care

The delivery of optimal chemotherapy dose intensity in patients with potentially curable malignancies should be considered a major quality indicator in cancer ...

Low-Dose Multi-Drug Chemotherapy: Balancing Efficacy ...

Notably, toxicities were significantly lower with the reduced doses, and progression-free survival with reduced-dose chemotherapy and overall ...

Efficacy and Toxicity of Low-Dose versus Conventional ... - PMC

Interestingly, low-dose chemotherapy achieved the same desired potency as conventional-dose chemotherapy, with no differences in pooled ORR (RR=1.00, 95%CI [ ...

Efforts to Lower Cancer Drug Doses Gain Steam - NCI

In a recent survey of 1,221 women with metastatic breast cancer, 86% reported having had at least one side effect related to their treatment.

Impact of Chemotherapy Dose Intensity on Cancer Patient ...

In early studies, dose-dense schedules showed an increase in survival, whereas the benefit of dose escalation studies has been less consistent and may be ...

The rationale of dose–response curves in selecting cancer ...

21 Dose intensity was subsequently shown to correlate with outcome in prospective clinical studies in various tumour types, including breast and ovarian, acute ...

10 Best Practices for Implementing Low-Dose Multi-Drug ...

Research shows that low-dose chemotherapy regimens can lead to fewer side effects and improved quality of life for patients without compromising ...

New Report Supports Overhaul of Cancer Drug Dosing

86% of patients with metastatic breast cancer reported significant treatment-related side effects, often leading to dose reductions. Collect ...

Chemotherapy Dose Intensity and Overall Survival Among ...

Among 874 patients with advanced breast cancer, 33.2% experienced dose delays ≥ 7 days, 48.7% experienced dose reductions ≥ 15%, and 38.9% had RDI < 85%. Dose ...

The Essential Role of Patient-Reported Outcomes (PROs)

Oncology clinical trials commonly consider clinician-reported safety data, dose modifications, dose discontinuations, and severe AEs including hospitalizations