Treatment With ATRA-IV and Depakote in Patients With Advanced Solid Tumor Malignancies

September 12, 2006 updated by: Weill Medical College of Cornell University

Phase I Trial of ATRA-IV and Depakote in Patients With Advanced Solid Tumor Malignancies

The purpose of this study is to find out the highest tolerated dose of Depakote in combination with liposome encapsulated all-trans retinoic acid (ATRA-IV) in patients with advanced solid tumor malignancies.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

To determine the maximum tolerated dose of Depakote in combination with liposome encapsulated all-trans retinoic acid (ATRA-IV) in patients with advanced solid tumor malignancies.

This will be a 2-step dose escalation study. Once the patient starts therapy at a designated dose level, it will not be escalated for that patient. Three patients at each dose level must complete 4 weeks of therapy before escalating to the next higher level. If none of the patients experience dose limiting toxicity (DLT), then 3 new patients will be treated with the next higher dose level.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Weill Medical College of Cornell University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with histologic confirmation of a solid tumor malignancy with clinical evidence of metastatic disease.
  • Patients must have failed at least one standard therapy, if available, for their malignancy. Patients may be entered on the trial without prior therapy if there is no standard effective therapy available.
  • No active brain metastases or epidural tumor.

Exclusion Criteria:

  • Concomitant administration of steroids.
  • Irradiation or chemotherapy within 14 days of start of protocol.
  • Evidence of another active cancer, except for non-melanoma, carcinoma of the skin and in-situ carcinoma of the cervix curatively treated, Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for greater than 5 years.
  • Women who are pregnant or lactating. Women or men of reproductive age who are unwilling to use two forms of effective contraception.
  • Patients with clinically significant cardiac, renal or hepatic disease; severe debilitating pulmonary disease; or history of diabetes mellitus prone to ketoacidosis.
  • Patients with a history of pancreatitis.
  • Patients with known hypersensitivity to retinoids or retinoic acid derivatives.
  • Patients with coagulation disorders, such as thrombophlebitis or pulmonary embolism.
  • Patients with pre-existing psychiatric condition, especially depression or a history of severe uncontrolled psychiatric disorder.
  • Patients with pre-existing thyroid abnormalities whose thyroid function cannot be maintained in the normal range.
  • Patients with chronic moderate to severe nausea.
  • Patients with history of epilepsy or a seizure disorder taking anti-convulsant medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the maximum tolerated dose of Depakote in combination with liposome encapsulated all-trans retinoic acid (ATRA-IV) in patients with advanced solid tumor malignancies.
To define the dose limiting and other toxicities of the combination therapy
To determine the dosing that should be used in future safety and efficacy (Phase II) trials

Secondary Outcome Measures

Outcome Measure
To study retinoic acid receptor expression and histone acetylation status to ascertain biologic effect on peripheral blood mononuclear cells and tissue obtained from selected patients who undergo tumor biopsies.
To assess for tumor responses to combination therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: David Nanus, M.D., Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Study Registration Dates

First Submitted

September 14, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

September 14, 2006

Last Update Submitted That Met QC Criteria

September 12, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1002-536

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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