Suspended

Romidepsin in Treating Patients With Locally Advanced or Metastatic Neuroendocrine Tumors

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What is being tested

romidepsin

+ laboratory biomarker analysis
Drug
Other
Who is being recruted

Gastrinoma
+7

+ Glucagonoma
+ Insulinoma
Over 18 Years
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2004

Summary

Principal SponsorNational Cancer Institute (NCI)
Last updated: June 4, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: March 1, 2004Actual date on which the first participant was enrolled.

Phase II trial to study the effectiveness of romidepsin in treating patients who have locally advanced or metastatic neuroendocrine tumors. Drugs used in chemotherapy, such as romidepsin, work in different ways to stop tumor cells from dividing so they stop growing or die. PRIMARY OBJECTIVES: I. Determine objective response rate in patients with locally advanced or metastatic neuroendocrine tumors treated with FR901288 (romidepsin). SECONDARY OBJECTIVES: I. Determine the toxicity of this drug in these patients. II. To measure serum tumor markers (pancreastatin, gastrin, pancreatic polypeptide, glucagon, substance-P, neurotensin, calcitonin, somatostatin, vasoactive intestinal peptide, gastrin releasing polypeptide, ACTH) depending on the tumor type pre-, during-, and post-treatment. III. To perform a nuclear medicine functional imaging scan (octreoscan) to evaluate the disease status pre-, during-, and post-treatment. IV. To perform histone acetylation assay in cytospins from peripheral blood mononuclear cells (PBMCs) to correlate with disease response and with immunologic parameters. V. To quantify gene expression by Real Time PCR of type 1 and type 2 cytokines, co-stimulatory molecules, and adhesion molecules in PBMCs obtained from the pre-, during-, and post-treatment blood samples. VI. To perform a multicolor flow cytometric analysis on fresh blood to assess activation of lymphocyte subsets and presence of co-stimulatory and adhesion molecules. VII. To perform in vitro functional assays for innate as well as antigen-specific T cell immune responses in PBMCs obtained from the pre-, during-, and post-treatment blood samples. OUTLINE: Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete remission (CR) receive 2 additional courses beyond CR. Patients are followed at 2-4 weeks.

Official TitlePhase II Study of Depsipeptide in Metastatic Neuroendocrine Tumors 
Principal SponsorNational Cancer Institute (NCI)
Last updated: June 4, 2013
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
25 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.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Gastrinoma
Glucagonoma
Insulinoma
Metastatic Gastrointestinal Carcinoid Tumor
Pancreatic Polypeptide Tumor
Pulmonary Carcinoid Tumor
Recurrent Gastrointestinal Carcinoid Tumor
Recurrent Islet Cell Carcinoma
Regional Gastrointestinal Carcinoid Tumor
Somatostatinoma
Criteria

Inclusion Criteria: * Histologically confirmed carcinoid tumor or islet cell neuroendocrine tumor * Well- or moderately-differentiated tumor * Metastatic and/or locally advanced disease * Measurable disease * Unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * Lesions in a previously irradiated area are not considered measurable * No truly non-measurable lesions, including the following: * Bone lesions * Leptomeningeal disease * Ascites * Pleural or pericardial effusion * Lymphangitis cutis/pulmonis * Abdominal masses not confirmed and followed by imaging * Cystic lesions * Ineligible for standard treatment * Performance status - ECOG 0-1 * At least 6 months * WBC \>= 3,000/mm\^3 * Absolute neutrophil count \>= 1,500/mm\^3 * Platelet count \>= 100,000/mm\^3 * Bilirubin =\< 1.5 mg/dL * AST and ALT =\< 2.5 times upper limit of normal * Creatinine =\< 1.5 mg/dL * 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, defined as ventricular tachycardia or ventricular fibrillation \>= 3 beats in a row * No left ventricular hypertrophy by EKG * No other significant cardiac disease * QTc \< 500 msec * LVEF \> 40% by resting MUGA * No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drug * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No other concurrent uncontrolled illness * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * More than 4 weeks since prior immunotherapy (e.g., interferon alfa) * More than 4 weeks since prior chemotherapy * More than 12 weeks since prior hepatic artery chemoembolization unless liver lesions are not the only indicator lesions * No prior FR901228 (depsipeptide) * No more than 1 prior systemic chemotherapy regimen for carcinoid or islet cell tumor (other than hepatic artery chemoembolization) * More than 4 weeks since prior oral or IV steroids (first 16 patients only) * Concurrent long-acting octreotide allowed at standard doses if dose has been stable for the past 12 weeks * Concurrent subcutaneous octreotide for breakthrough use for symptomatic relief allowed * No concurrent systemic steroids (first 16 patients only) * More than 4 weeks since prior radiotherapy * More than 4 weeks since prior investigational tumor-specific therapy * No other prior histone deacetylase inhibitors (e.g., valproic acid) * No concurrent hydrochlorothiazide * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent investigational or commercial agents or therapies for the malignancy


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
Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR receive 2 additional courses beyond CR.
Study Objectives
Primary Objectives

Frequency of response will be estimated with a 95% confidence interval.
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.
This study has 1 location
Suspended
Ohio State University Medical CenterColumbus, United StatesSee the location

SuspendedOne Study Center