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

Solid Tumor Malignancies Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00195156
• Other study ID #: 1002-536
• Status: Terminated
• Phase: Phase 1
• First received: September 14, 2005
• Last updated: September 12, 2006
• Start date: July 2003

Study information

• Verified date: September 2006
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor Malignancies

Intervention

Drug:
• ATRA-IV

• Depakote

Locations

Country	Name	City	State
United States	Weill Medical College of Cornell University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	To define the dose limiting and other toxicities of the combination therapy
Primary	To determine the dosing that should be used in future safety and efficacy (Phase II) trials
Secondary	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.
Secondary	To assess for tumor responses to combination therapy.