Suspended

S0400, FR901228 in Treating Patients With Advanced Cancer of the Urothelium

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What is being tested

Depsipeptide

Drug
Who is being recruted

Bladder Cancer

+ Transitional Cell Cancer of the Renal Pelvis and Ureter
+ Urethral Cancer

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2004

See protocol details

Summary

Principal SponsorSWOG Cancer Research Network
Last updated: November 2, 2012
Sourced from a government-validated database.Claim as a partner
Study start date: June 1, 2004Actual date on which the first participant was enrolled.

RATIONALE: Drugs used in chemotherapy, such as FR901228 (depsipeptide), work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with advanced cancer of the urothelium that has progressed or recurred after receiving one chemotherapy regimen. OBJECTIVES: * Determine the response (confirmed complete and partial) in patients with advanced transitional cell carcinoma of the urothelium that has progressed after prior chemotherapy when treated with FR901228 (depsipeptide) . * Determine progression-free and overall survival of patients treated with this drug. * Determine the qualitative and quantitative toxic effects of this drug in these patients. * Determine, preliminarily, the effects of this drug on reversing tumor promoter gene methylation in these patients. * Correlate, preliminarily, tumor DNA in plasma with response or outcome in patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response receive 2 additional courses of treatment. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Official TitleA Phase II Study of Depsipeptide (NSC-630176) In Patients With Advanced Transitional Cell Carcinoma Of The Urinary Tract Who Have Progressed After Receiving One Prior Chemotherapy Regimen For Advanced Disease 
Principal SponsorSWOG Cancer Research Network
Last updated: November 2, 2012
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
6 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Criteria

DISEASE CHARACTERISTICS: * Histologically confirmed transitional cell carcinoma of the urothelium (bladder, renal pelvis, ureter, or urethra) * Metastatic disease * Node-positive, non-metastatic disease that is unresectable is allowed * Poorly differentiated transitional cell carcinoma OR predominant transitional cell carcinoma with rare foci of squamous differentiation or rare foci of adenocarcinoma allowed * The following histologic types are not allowed: * Adenocarcinoma * Small cell carcinoma * Sarcoma * Squamous cell carcinoma * Mixed adeno/squamous/transitional histology * Measurable disease * At least 1 unidimensionally measurable lesion ≥ 2 cm by conventional techniques OR ≥ 1 cm by spiral CT scan * Soft tissue disease irradiated within the past 2 months is not considered measurable * Disease progression or recurrence after 1, and only 1, prior systemic chemotherapy regimen that included cisplatin or carboplatin for metastatic disease * Not curable by surgery or radiotherapy * No known brain metastases PATIENT CHARACTERISTICS: Age * Not specified Performance status * Zubrod 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * White blood cell (WBC) count ≥ 3,000/mm\^3 Hepatic * Aspartate aminotransferase (SGOT) / alanine aminotransferase (SGPT) ≤ 2.5 times upper limit of normal (ULN) * Bilirubin normal Renal * Creatinine ≤ 2 times ULN Cardiovascular * Corrected QT interval (QTc) \< 500 msec * Left ventricular ejection fraction (LVEF) \> 40% by Multi Gated Acquisition Scan (MUGA) * No New York Heart Association class III or IV congestive heart failure * No myocardial infarction within the past year * No uncontrolled dysrhythmias * No poorly controlled angina * No serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row) * No left ventricular hypertrophy on EKG * No other significant cardiac disease Other * Potassium ≥ 4 mmol/L * Magnesium ≥ 2 mg/dL * Not pregnant or nursing * Fertile patients must use effective contraception * No prior allergic reaction to compounds of similar chemical or biological composition to FR901228 (depsipeptide) * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy Chemotherapy * See Disease Characteristics * At least 28 days since prior chemotherapy * No prior FR901228 (depsipeptide) * No other concurrent chemotherapy Endocrine therapy * No concurrent hormonal therapy Radiotherapy * See Disease Characteristics * More than 28 days since prior radiotherapy * No concurrent radiotherapy Surgery * More than 28 days since prior surgery Other * Recovered from all prior therapy * More than 28 days since prior intravesical therapy * No concurrent hydrochlorothiazide * No concurrent agent that causes QTc prolongation * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational histone deacetylase inhibitor agents or drugs (e.g., sodium valproate) * No other concurrent anticancer therapy

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Depsipeptide
Study Objectives
Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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SuspendedNo study centers