Use of Hydralzaine and Valproic Acid in Advanced Solid Tumor Malignancies
Information source: New Mexico Cancer Care Alliance
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lung Cancer
Intervention: Hydralazine and Valproic Acid (Drug)
Phase: Phase 1
Status: Active, not recruiting
Sponsored by: New Mexico Cancer Care Alliance Official(s) and/or principal investigator(s): Monte Shaheen, M.D., Principal Investigator, Affiliation: University of New Mexico Cancer Center
Summary
1. Primary Objective:
The primary endpoint to this study will be to document the toxicities, and
reversibility of toxicities, of this regimen of hydralazine and valproic acid in
patients with advanced, unresectable, previously treated lung cancers, for whom no
acceptable standard therapy is available. A primary endpoint will be to determine any
potential dose limiting toxicities, and the Maximal Tolerated Dose of this regimen.
2. Secondary Objectives:
The secondary endpoint of this study will be to determine any potential anti-tumor effects,
as determined by the objective tumor response (complete and partial responses), clinical
benefit (complete and partial responses, and clinical benefit), the time to tumor response,
the time to tumor progression, and the overall survival.
Clinical Details
Official title: A Phase 1 Protocol of Hydralzaine and Valproic Acid in Advanced Solid Tumor Malignancies
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: A primary endpoint will be to determine any potential dose limiting toxicities, & the Maximal Tolerated Dose of hydralazine & valproic acid regimen.
Secondary outcome: To determine any potential anti-tumor effects, as determined by the objective tumor response, clinical benefit, the time to tumor response, the time to tumor progression, and the overall survival.
Detailed description:
This study will be an open-label, non-randomized, dose-escalation phase I trial which will
enroll in sequential cohorts.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
ELIGIBILITY:
1. All patients with lung cancer who have disease which has been previously treated
and/or for which there is no acceptable standard treatment regimen available, and
cannot be treated definitively with either surgery or radiotherapy.
2. All will be appropriate candidates for treatment, and are not candidates for
treatment with protocols of higher priority.
3. All patients should have an ECOG/Zubrod/SWOG performance status of less than less
than 2 at the time of the initiation of therapy
4. Adequate end-organ function
5. No severe comorbid disease
6. Ability to provide informed consent.
7. Signed Informed Consent
8. ECOG/Zubrod/SWOG Performance Status less than 2
9. Life expectancy greater than 8 weeks
10. Male or female' age greater than 18 years
11. Patients of childbearing potential must be using an effective means of contraception.
12. Histologic diagnosis of lung cancer that is advanced and cannot be treated adequately
by radiotherapy or surgery; or metastatic disease, and for which there is no standard
chemotherapeutic option remaining or available
13. All participants must have either previously received or refused standard
chemotherapy
14. Baseline laboratory values (bone marrow, renal, hepatic):
Adequate bone marrow function:
1. Absolute neutrophil count greater than 1000/µL
2. Platelet count greater than 100'000/µL
Renal function:
a. Serum creatinine less than 2. 0 mg %
Hepatic function:
1. Bilirubin less than 1. 5x normal
2. Serum calcium less than 12 mg/dl
Exclusion Criteria
1. Pregnant or lactating females
2. Myocardial infarction or ischemia within the 6 months before Cycle 0' Day 0
3. Uncontrolled' clinically significant dysrhythmia
4. Prior radiotherapy to an indicator lesion unless there is objective evidence of tumor
growth in that lesion
5. Prior autoimmune disease
6. Uncontrolled metastatic disease of the central nervous system
7. Radiotherapy within the 2 weeks before Cycle 1' Day - 14
8. Surgery within the 2 weeks before Cycle 1' Day - 14
9. Any co morbid condition that' in the view of the attending physician' renders the
patient at high risk from treatment complications
Locations and Contacts
University of New Mexico Cancer Center, Albuquerque, New Mexico 87106, United States
Additional Information
University of New Mexico Cancer Center New Mexico Cancer Care Alliance
Starting date: July 2008
Last updated: March 3, 2015
|