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Alkylating agents

Cisplatin for Lung Cancer

Phase 1
Recruiting
Led By C. Matthew Kinsey, MD, MPH
Research Sponsored by University of Vermont
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have adequate organ and marrow function as defined below: Leukocytes ≥3,000/microliter, Platelets ≥100,000/microliter, Total bilirubin ≤ institutional upper limit of normal (ULN), Aspartate aminotransferase /Alanine aminotransferase ≤3 × institutional upper limit of normal, Creatinine ≤ institutional ULN
Presence of a target lesion with a minimum volume of 1.0 cm3, (approximately1.2 cm in diameter) and ≤ 5.0 cm in diameter
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed from tissue obtained on day of bronchoscopy and day of surgical resection
Awards & highlights

Study Summary

This trial is a Phase I study, which is the first step in testing a new cancer treatment. The goal is to find the highest dose of the new treatment that can be given without causing too much harm.

Who is the study for?
Adults over 18 with early-stage lung cancer (stage I-IIb) that's likely operable. They need a target lesion of specific size, good performance status, and normal organ/marrow function. Excluded are those allergic to cisplatin, recently on other trials or chemo, pregnant/breastfeeding women, and those with serious illnesses or prior radiation to the lesion.Check my eligibility
What is being tested?
The trial is testing different doses of cisplatin injected directly into the tumor during bronchoscopy to find the highest dose patients can tolerate without severe side effects. This method uses real-time imaging for precision.See study design
What are the potential side effects?
Cisplatin may cause kidney damage, hearing loss, nausea and vomiting, nerve damage leading to numbness or tingling in limbs (neuropathy), blood disorders like low white cell count increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My blood counts and liver/kidney functions are within normal ranges.
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My cancer has a visible tumor between 1.2 cm and 5 cm wide.
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A heart and lung surgeon agrees I can likely have surgery and that a specific cancer drug won't make surgery harder.
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My lung cancer diagnosis was confirmed by a quick test during my procedure.
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My lung cancer is in the early or middle stage, confirmed by scans.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I have another cancer type, but it won't affect this trial's treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 2 weeks of delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 2 weeks of delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of dose limiting toxicity
Secondary outcome measures
Blood biomarker panel
Major pathologic response
Tissue biomarker panel

Side effects data

From 2014 Phase 4 trial • 45 Patients • NCT02000531
29%
Nausea
19%
Leukopenia
14%
Anaemia
14%
Neutropenia
14%
Thrombocytopenia
14%
Alanine aminotransferase increased
14%
Vomiting
14%
White blood cell count decreased
10%
Platelet count decreased
10%
Aspartate aminotransferase increased
10%
Neutrophil count decreased
5%
Diarrhea
5%
Musculoskeletal pain
5%
Dizziness
5%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Erlotinib-Chemotherapy
Chemotherapy-Erlotinib

Trial Design

1Treatment groups
Experimental Treatment
Group I: Intratumoral Cisplatin ArmExperimental Treatment1 Intervention
Single arm approach. There is no comparator or placebo group. Cisplatin will be administered directly into a non-small cell lung cancer, following imaging verification and pathologic diagnosis, during a single bronchoscopic procedure.

Find a Location

Who is running the clinical trial?

University of VermontLead Sponsor
265 Previous Clinical Trials
3,743,481 Total Patients Enrolled
Johnson & JohnsonIndustry Sponsor
105 Previous Clinical Trials
26,399 Total Patients Enrolled
C. Matthew Kinsey, MD, MPHPrincipal Investigator - University of Vermont
University of Vermont
1 Previous Clinical Trials
9 Total Patients Enrolled

Media Library

cis-diamminedichloroplatinum (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT04809103 — Phase 1
Non-Small Cell Lung Cancer Research Study Groups: Intratumoral Cisplatin Arm
Non-Small Cell Lung Cancer Clinical Trial 2023: cis-diamminedichloroplatinum Highlights & Side Effects. Trial Name: NCT04809103 — Phase 1
cis-diamminedichloroplatinum (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04809103 — Phase 1

Frequently Asked Questions

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

Has the FDA sanctioned cis-diamminedichloroplatinum for use in treatments?

"Because cis-diamminedichloroplatinum is only in its first clinical trial, there has been limited data collected on safety and efficacy. For this reason, our team at Power rated the drug's safety a 1."

Answered by AI

Is entrance to this experiment available for participants at the moment?

"The clinicaltrials.gov page for this research trial verifies that recruitment is currently ongoing. It was initially published on the 8th of March 2021, and last revised on May 20th 2022."

Answered by AI

To what extent has enrollment for this trial been successful?

"Affirmative. Data present on clinicaltrials.gov proves that this medical trial, which was initially presented on March 8th 2021, is currently enlisting patients. 10 individuals are being admitted across a single site."

Answered by AI

Has cis-diamminedichloroplatinum been tested in any other scientific trials?

"Currently, there are 689 active clinical trials conducted on cis-diamminedichloroplatinum with 274 of those being Phase 3 studies. Of these trial sites, the vast majority are located in Shanghai; however, 43222 locations internationally have taken up research into this drug."

Answered by AI

To what afflictions does cis-diamminedichloroplatinum provide a remedy?

"Cis-diamminedichloroplatinum can be administered to treat advanced ovarian cancer, testicular cancer that is unresponsive to traditional treatments, and other forms of refractory malignancies."

Answered by AI
~2 spots leftby Mar 2025