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Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

cisplatin

dimesna

paclitaxel

Patrick J. Creaven, MBBS, PhD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs such as dimesna may protect normal cells from the side effects of chemotherapy.

PURPOSE: This phase I trial is studying the side effects and best dose of dimesna in treating patients with solid tumors who are receiving cisplatin and paclitaxel.

OBJECTIVES:

* Determine the maximum tolerated dose (MTD) of dimesna administered prior to cisplatin and paclitaxel in patients with solid tumors.
* Determine the dose related qualitative and quantitative side effects of dimesna administered on this schedule in these patients.
* Determine the minimum safe volume of intravenous hydration after the determination of the MTD of dimesna in these patients.
* Investigate the possible protective side effects of dimesna in reducing or preventing the development of cisplatin induced nephrotoxicity and observe possible protective effects against cisplatin or paclitaxel related neurotoxicity and myelosuppression in these patients.
* Investigate the pharmacokinetic behavior of dimesna in the plasma and urine on this schedule of administration in this patient population.

OUTLINE: This is a dose-escalation, two-stage, multicenter study.

During stage I, patients receive a single dose of dimesna IV over 15 minutes 7 days prior to chemotherapy. Patients then receive paclitaxel IV over 3 hours followed by dimesna IV over 15-30 minutes followed immediately by cisplatin IV over 1 hour on day 1 every 3 weeks. Patients continue courses of paclitaxel, dimesna, and cisplatin every 3 weeks in the absence of disease progression or unacceptable toxicity for up to 6 courses.

In stage I, cohorts of 3-6 patients each receive escalating doses of dimesna until the maximum tolerated dose (MTD) is reached. The MTD is defined as the highest dose at which no more than 1 of 6 patients experiences dose limiting toxicity (DLT). The MTD of dimesna is then used in stage II of the study, in which the volume of pre and post cisplatin intravenous saline hydration is reduced in cohorts of 3-6 patients each. The MTD intensity of cisplatin is defined as the least saline hydration volume at which no more than 1 of 6 patients experience DLT.

PROJECTED ACCRUAL: Approximately 35 patients will be accrued into this study.

Dimesna in Treating Patients With Solid Tumors Who Are Undergoing Treatment With Cisplatin and Paclitaxel

Phase I Trial of Escalating Doses of BNP7787 in Patients With Solid Tumors Undergoing Treatment With Cisplatin and Taxol

National Cancer Institute (NCI)

Roswell Park Cancer Institute

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Dimesna in Treating Patients With Solid Tumors Who Are Undergoing Treatment With Cisplatin and Paclitaxel	NCT00003569	Head and Neck C... Lung Cancer Neurotoxicity Ovarian Cancer	cisplatin dimesna paclitaxel	18 Years -	Roswell Park Cancer Institute
Dimesna in Treating Patients With Solid Tumors Who Are Undergoing Treatment With Cisplatin and Paclitaxel	NCT00003569	Head and Neck C... Lung Cancer Neurotoxicity Ovarian Cancer	cisplatin dimesna paclitaxel	18 Years -	Roswell Park Cancer Institute

Spots Global Cancer Trial Database for dimesna

Every month we try and update this database with for dimesna cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for dimesna

Every month we try and update this database with for dimesna cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for dimesna cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.