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

This study has been terminated.
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00195156
First received: September 14, 2005
Last updated: September 12, 2006
Last verified: September 2006
  Purpose

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.


Condition Intervention Phase
Solid Tumor Malignancies
Drug: ATRA-IV
Drug: Depakote
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of ATRA-IV and Depakote in Patients With Advanced Solid Tumor Malignancies

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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:
  • 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.

Study Start Date: July 2003
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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00195156

Locations
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: David Nanus, M.D. Weill Medical College of Cornell University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00195156     History of Changes
Other Study ID Numbers: 1002-536
Study First Received: September 14, 2005
Last Updated: September 12, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:
Solid Tumor Malignancies

Additional relevant MeSH terms:
Neoplasms
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 16, 2014