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


Phase 1
21 Years
N/A
Not Enrolling
Both
Solid Tumor Malignancies

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

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.

Principal Investigator

David Nanus, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Weill Medical College of Cornell University

Authority:

United States: Food and Drug Administration

Study ID:

1002-536

NCT ID:

NCT00195156

Start Date:

July 2003

Completion Date:

Related Keywords:

  • Solid Tumor Malignancies
  • Solid Tumor Malignancies
  • Neoplasms

Name

Location

Weill Medical College of Cornell UniversityNew York, New York  10021