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Monoclonal Antibodies

Daratumumab for Bladder and Kidney Cancer

Q: In what cases is Nephrectomy utilized as a treatment option?

Nephrectomy is a procedure employed to treat <a href="https://www.withpower.com/clinical-trials/multiple-myeloma">multiple myeloma</a>, refractory cases of the same <a href="https://www.withpower.com/clinical-trials/cancer">cancer</a> and cell transplants. Additionally, it has been used in combination with biological response modifiers for therapeutic effect.

Q: Have past experiments included Nephrectomy as an element?

Currently, there are 140 ongoing trials investigating Nephrectomy. Out of these studies, 26 have progressed to Phase 3. Although most occur in Harrison, <a href="https://www.withpower.com/clinical-trials/new-york">New york</a>, 5582 other research sites across the world are also running tests for this procedure.

Q: Are fresh participants still being enrolled into this research project?

Recruitment for this clinical trial has since ceased. It was posted on May 29th 2018, with the latest data being updated on September 22nd 2022. If you are seeking an alternative study, there are 2894 trials involving carcinoma and 140 nephrectomy trials currently looking for participants.

Q: What is the exact size of the cohort engaging in this medical research?

This trial is not currently accepting new patients. It was initially posted on the 29th of May 2018 and most recently updated in September 2022. If you are seeking alternate studies, there are 2894 trials recruiting participants with carcinoma and 140 trails for Nephrectomy that have active recruitment programs.

Phase < 1

Waitlist Available

Led By Matthew T Campbell

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

BLADDER: ANC >= 1500/mm^3 without colony stimulating factor support (clinical laboratory values at screening)

RENAL & BLADDER: Eastern Cooperative Oncology Group (ECOG) performance status (PS) grade of =< 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 30 days post-surgery

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of daratumumab in patients with metastatic renal cell carcinoma or muscle invasive bladder cancer.

Who is the study for?

This trial is for adults with muscle invasive bladder cancer or metastatic kidney cancer who are not pregnant, have an ECOG performance status of <=2, and meet specific health criteria like blood counts and organ function. They must not be on other trials, have certain infections (like HIV), or untreated brain metastases. Participants should agree to use contraception during the study.Check my eligibility

What is being tested?

The trial tests daratumumab's safety and effectiveness in treating these cancers. It includes a nephrectomy (kidney removal) for kidney cancer patients, biopsies to examine tissue samples, laboratory biomarker analysis to monitor responses, and possibly a metastasectomy if there are isolated areas of spread that can be surgically removed.See study design

What are the potential side effects?

Daratumumab may cause immune system reactions such as infusion-related reactions; it could also affect blood cell counts leading to increased risk of infections or bleeding. Organ-specific inflammation is possible too.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My white blood cell count is healthy without needing medication.

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I can take care of myself but might not be able to do heavy physical work.

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I cannot receive cisplatin for my bladder cancer due to kidney, heart, nerve issues, or hearing loss.

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My kidney function is good enough for the trial, and I am not on dialysis.

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My hemoglobin level is 9 g/dL or higher.

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My blood protein level is at least 2.8g/dl.

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My kidney function is good enough for the trial, not on dialysis.

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My kidney cancer has a clear cell component.

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I have a kidney tumor that can be measured and is not where my surgery will be.

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My liver enzymes, ALT and AST, are within normal limits.

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My bladder cancer diagnosis was confirmed through a biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 30 days post-surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 30 days post-surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 30 days post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of adverse events

Incidence of surgical complications (Bladder cohort)

Rate of surgical delay (Bladder cohort)

Secondary outcome measures

Best objective response rate (ORR) (Renal cohort)

Pathologic response (Bladder cohort)

Progression-free survival (PFS) (Renal cohort)

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort 2 Bladder (daratumumab)Experimental Treatment2 Interventions

Patients receive daratumumab IV over 8 hours for the first dose and then over 4 hours for all doses thereafter beginning at week 1. Cycles repeat every week for up to 4 weeks in the absence of disease progression or unacceptable toxicity.

Group II: Cohort 1 Renal (daratumumab, biopsy, surgery)Experimental Treatment5 Interventions

Patients receive daratumumab IV over 8 hours for the first dose and then over 4 hours for all doses thereafter during weeks 1-8. Treatment repeats every week for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo biopsy, nephrectomy, or metastasectomy during weeks 10-12. Patients may then restart treatment with daratumumab beginning 2 weeks after biopsy or 4-6 weeks after nephrectomy or metastasectomy. Cycles repeat every 2 weeks for 4 months and then monthly for 1 year in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nephrectomy

2013

Completed Phase 3

~1430

Biopsy

2014

Completed Phase 4

~1090

Daratumumab

2014

Completed Phase 3

~1860

Metastasectomy

2010

N/A

~100

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,972 Previous Clinical Trials

1,787,282 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,660 Previous Clinical Trials

40,924,255 Total Patients Enrolled

Janssen Research & Development, LLCIndustry Sponsor

975 Previous Clinical Trials

6,384,291 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what cases is Nephrectomy utilized as a treatment option?

"Nephrectomy is a procedure employed to treat multiple myeloma, refractory cases of the same cancer and cell transplants. Additionally, it has been used in combination with biological response modifiers for therapeutic effect."

Answered by AI

Have past experiments included Nephrectomy as an element?

"Currently, there are 140 ongoing trials investigating Nephrectomy. Out of these studies, 26 have progressed to Phase 3. Although most occur in Harrison, New york, 5582 other research sites across the world are also running tests for this procedure."

Answered by AI

Are fresh participants still being enrolled into this research project?

"Recruitment for this clinical trial has since ceased. It was posted on May 29th 2018, with the latest data being updated on September 22nd 2022. If you are seeking an alternative study, there are 2894 trials involving carcinoma and 140 nephrectomy trials currently looking for participants."

Answered by AI

What is the exact size of the cohort engaging in this medical research?

"This trial is not currently accepting new patients. It was initially posted on the 29th of May 2018 and most recently updated in September 2022. If you are seeking alternate studies, there are 2894 trials recruiting participants with carcinoma and 140 trails for Nephrectomy that have active recruitment programs."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Daratumumab in Treating Patients With Muscle Invasive Bladder Cancer or Metastatic Kidney Cancer

2018. "Daratumumab in Treating Patients With Muscle Invasive Bladder Cancer or Metastatic Kidney Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03473730.

All > Bladder Cancer > Kidney Cancer