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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00195156 |
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Date of registration:
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14/09/2005 |
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Primary sponsor: |
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Public title:
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Treatment With ATRA-IV and Depakote in Patients With Advanced Solid Tumor Malignancies
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Scientific title:
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Phase I Trial of ATRA-IV and Depakote in Patients With Advanced Solid Tumor Malignancies |
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Date of first enrolment:
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July 2003 |
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Target sample size:
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00195156 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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David Nanus, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Weill Medical College of Cornell University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
21 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Solid Tumor Malignancies
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Intervention(s)
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Drug: ATRA-IV
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Drug: Depakote
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Primary Outcome(s)
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To define the dose limiting and other toxicities of the combination therapy
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To determine the dosing that should be used in future safety and efficacy (Phase II) trials
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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.
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Secondary Outcome(s)
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To assess for tumor responses to combination therapy.
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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.
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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