NCT00195156

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

September 14, 2006

Status Verified

September 1, 2006

First QC Date

September 14, 2005

Last Update Submit

September 12, 2006

Conditions

Solid Tumor Malignancies

Keywords

Solid Tumor Malignancies

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • 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.

Interventions

ATRA-IVDRUG
DepakoteDRUG

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Related Publications (1)

  • Orfali N, O'Donovan TR, Cahill MR, Benjamin D, Nanus DM, McKenna SL, Gudas LJ, Mongan NP. All-trans retinoic acid (ATRA)-induced TFEB expression is required for myeloid differentiation in acute promyelocytic leukemia (APL). Eur J Haematol. 2020 Mar;104(3):236-250. doi: 10.1111/ejh.13367. Epub 2020 Jan 13.

    PMID: 31811682DERIVED

MeSH Terms

Interventions

Valproic Acid

Intervention Hierarchy (Ancestors)

Pentanoic AcidsValeratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsFatty Acids, VolatileFatty AcidsLipids

Study Officials

  • David Nanus, M.D.

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 19, 2005

Study Start

July 1, 2003

Last Updated

September 14, 2006

Record last verified: 2006-09

Locations

US(1)