A Phase 1 interventional study of vorinostat and diagnostic laboratory biomarker analysis in HIV Infection, Recurrent Anal Cancer and Recurrent Breast Cancer, sponsored by AIDS Malignancy Consortium. Terminated at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-29.
Sponsored by AIDS Malignancy Consortium · Phase 1, Interventional, and Treatment
This phase I clinical trial is studying the side effects and the best dose of vorinostat when given together with paclitaxel and carboplatin in treating patients with metastatic or recurrent solid tumors and human immunodeficiency virus (HIV) infection. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving vorinostat together with paclitaxel and carboplatin may kill more tumor cells.
NOTE: An administrative decision was made by NCI to halt further study of vorinostat in this specific patient population as of February 1, 2013. No patients remain on vorinostat. Going forward this study will determine the safety and tolerability of the paclitaxel and carboplatin combination in this patient population.
PRIMARY OBJECTIVES:
I. To determine the safety and tolerability of vorinostat in combination with paclitaxel and carboplatin in solid tumor patients with HIV infection.
II. To determine the maximal tolerated dose (MTD) of the combination in this patient population.
*NOTE: An administrative decision was made by Cancer Therapy Evaluation Program (CTEP) to halt further study of vorinostat in this specific patient population as of February 1, 2013, and no patients remain on vorinostat. The primary objective going forward will determine the safety and tolerability of the paclitaxel and carboplatin combination in this patient population.
SECONDARY OBJECTIVES:
I. To preliminarily assess response rates of the therapeutic combination in lung, head and neck, and esophageal cancers.
II. To evaluate the pathological characteristics of non-acquired immunodeficiency syndrome (AIDS) defining cancers of the upper aerodigestive tract.
III. To determine the presence and oncogenic activity of human papillomavirus (HPV) infection in tumor tissues and to correlate HPV infection with clinical outcomes.
IV. To investigate possible pharmacokinetic interactions between paclitaxel and antiretroviral therapy in persons with HIV infection.
OUTLINE: This is a multicenter, dose-escalation study of vorinostat followed by an expansion cohort study.
Patients receive vorinostat orally (PO) once daily on days 1-5 and paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Some patients undergo blood sample collection at baseline and periodically during course 1 for pharmacokinetic studies and HIV viral load analysis.
Note: An administrative decision was made by CTEP to halt further study of vorinostat in this specific patient population as of February 1, 2013. No patients remain on vorinostat. The primary objective going forward will determine the safety and tolerability of the paclitaxel and carboplatin combination in this patient population, without vorinostat. The information pertaining to vorinostat is for historical purposes.
After completion of study therapy, patients are followed up every 6 months for up to 3 years.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 17 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →AIDS Malignancy Consortium is the lead sponsor of 61 studies on the registry; 10 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Before February 1, 2013, patients also received vorinostat PO once daily on days 1-5 with paclitaxel and carboplatin.
Drug: vorinostat · Other: diagnostic laboratory biomarker analysis · Other: pharmacological study · Drug: carboplatin · Drug: paclitaxel
Given PO
Also known as: L-001079038, SAHA, suberoylanilide hydroxamic acid, Zolinza
Correlative studies
Correlative studies
Also known as: pharmacological studies
Given IV
Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin
Given IV
Also known as: Anzatax, Asotax, TAX, Taxol
Incidence of adverse events during paclitaxel and carboplatin treatment according to dose-limiting toxicities (DLTs), graded using Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0)
Time frame: 21 days
Response rates in patients with lung, head and neck, and esophageal cancers assessed by Response Evaluation Criteria for Solid Tumors (RECIST) 1.1
For each stratum, binomial proportions and their 95% confidence intervals will be used to preliminarily assess response rates of the therapeutic combination in lung, head and neck, and esophageal cancers.
Time frame: Up to 3 years
Effects of therapy on HIV viral load and CD4 cell count
Time frame: Baseline and at 6, 12, and 18 weeks
This study is terminated, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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AIDS Malignancy Consortium