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Hodgkin's DiseasePhase 1SAHANCT00691210

Phase I Vorinostat in Combination With Niacinamide and Etoposide for Lymphoid Malignancies

A Phase 1 study testing Vorinostat, Niacinamide and Etoposide in people with Hodgkin's Disease and Non-Hodgkin's Lymphoma, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to test the safety of a combination of two anticancer medicines, called vorinostat and etoposide, with a high dose of a vitamin called niacinamide. These medications will be tested at different dose levels. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hodgkin's Disease, Non-Hodgkin's Lymphoma
What is being tested?
Vorinostat, Niacinamide and Etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
Jun 2008to Mar 2015
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed relapsed or refractory non-Hodgkin's lymphoma or Hodgkin's Disease (WHO criteria), for which they are unwilling or unable to undergo an autologous stem cell transplant
  • Must have received first line chemotherapy. No upper limit to number of prior therapies
  • Evaluable Disease
  • Age >18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status <2
  • Life expectancy of greater than 3 months
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  • Patients must have adequate organ and marrow function
  • Adequate Contraception
  • Ability to understand and the willingness to sign a written informed consent document

Who cannot join

  • Prior Therapy
  • Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Patient is on any systemic steroids that have not been stabilized to the equivalent of ≤10 mg/day prednisone during the 7 days prior to the start of the study drugs
  • No monoclonal antibody within 3 months unless evidence of progression
  • Patients may not be receiving any other investigational agents
  • Patients with known central nervous system metastases, including lymphomatous meningitis
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  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat, niacinamide or etoposide
  • Uncontrolled intercurrent illness
  • Pregnant women
  • Nursing women
  • Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy, the patient must be disease-free for ≥ 3 years
  • Patient is known to be Human Immunodeficiency Virus (HIV)-positive
  • Active Hepatitis A, Hepatitis B, or Hepatitis C infection
  • Patient has a history of surgery that would interfere with the administration or absorption of the oral study drugs

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Center for Lymphoid Malignancies at CUMC

    New York, New York, 10019

Other trials in United States

About this study

Official title: Phase I Study of Vorinostat in Combination With Niacinamide, and Etoposide for the Treatment of Patients With Relapsed and Refractory Lymphoid Malignancies

The purpose of this study is to test the safety of a combination of two anticancer medicines, called vorinostat and etoposide, with a high dose of a vitamin called niacinamide. These medications will be tested at different dose levels. The investigators want to find out what effects, good and/or bad, it has on patients and their recurrent lymphoma. The first two drugs, vorinostat and niacinamide, suppress survival signals that lymphoma cells depend on. The third drug, etoposide can kill sensitive lymphoma cells alone or in combination with other chemotherapy drugs. Vorinostat is an anticancer agent that been approved by the Food and Drug Administration for use in cutaneous T-cell lymphoma. It is being evaluated in this study in combination with other anticancer medicines for use in other types of lymphoma. Vorinostat's use in combination with anticancer regimens is experimental. Niacinamide is a vitamin that is investigational or experimental when given at high doses as an anticancer agent. Niacinamide has not yet been approved by the Food and Drug Administration for use in lymphoma. Etoposide has been approved by the Food and Drug Administration for use in aggressive non-Hodgkin's lymphoma. However, the way it will be given in this clinical study is experimental.

Read the detailed description

Subjects will be treated with vorinostat administered orally with daily dosing for 14 days of a 21-day treatment cycle in combination with niacinamide administered orally for 14 days in 21-day treatment cycle and etoposide administered intravenously on days 8,9 and 10 of a 21-day treatment cycle. Etoposide dose will be escalated until maximum tolerated dose (MTD) is determined.

Being tested
Vorinostat, Niacinamide, Etoposide
Keywords
Hodgkin's Disease, Non-Hodgkin's Lymphoma
Medical subject headings
Hodgkin Disease, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VorinostatDrug

    Also called SAHA

    Dose escalation scheme (400 mg)

    Vorinostat is used to treat cutaneous T-cell lymphoma (CTCL, a type of cancer) in people whose disease has not improved, has gotten worse, or has come back after taking other medications. Vorinostat is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by killing or stopping the growth of cancer cells.

  • NiacinamideDrug

    Also called Nicotinamide

    Dose escalation scheme (20, 40, 60, 80, 100 mg/kg rounded to 100 mg)

    Niacinamide is a water soluble B-vitamin that has been evaluated for use in the treatment of pellagra, bullous pemphigoid, and as a radiation sensitizer in head and neck cancer.

  • EtoposideDrug

    Also called VP-16

    Dose escalation scheme (0, 25, 50, 100 mg/m2)

    Etoposide is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as a "plant alkaloid" and "topoisomerase II inhibitor."

Study groups in NCT00691210
Study groupRoleWhat they receive
V/N: Level 1ExperimentalVorinostat: 400mg Niacinamide: 20 mg/kg rounded to 100mg
Receives: Drug: Vorinostat; Drug: Niacinamide
V/N: Level 2ExperimentalVorinostat: 400mg Niacinamide: 40 mg/kg rounded to 100mg
Receives: Drug: Vorinostat; Drug: Niacinamide
V/N: Level 3ExperimentalVorinostat: 400mg Niacinamide: 60 mg/kg rounded to 100mg
Receives: Drug: Vorinostat; Drug: Niacinamide
V/N: Level 4ExperimentalVorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg
Receives: Drug: Vorinostat; Drug: Niacinamide
V/N: Level 5ExperimentalVorinostat: 400mg Niacinamide: 100 mg/kg rounded to 100mg
Receives: Drug: Vorinostat; Drug: Niacinamide
V/N/E: Level 1ExperimentalVorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 25 mg/m2
Receives: Drug: Vorinostat; Drug: Niacinamide; Drug: Etoposide
V/N/E: Level 2ExperimentalVorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 50 mg/m2
Receives: Drug: Vorinostat; Drug: Niacinamide; Drug: Etoposide
V/N/E: Level 3ExperimentalVorinostat: 400mg Niacinamide: 80 mg/kg rounded to 100mg Etoposide: 100 mg/m2
Receives: Drug: Vorinostat; Drug: Niacinamide; Drug: Etoposide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Maximum Tolerated Dose (MTD) of Niacinamide in the Combination of Vorinostat and Niacinamide

    Measured: 3 years

Secondary outcomes (4)

  1. The Greatest Number of Cycles Received in Each Treatment Group

    The highest number of cycles received by an individual participant in the treatment groups. Each cycle was 21 days long.

    Measured: up to 45 weeks

  2. The Number of Dose Delays and Reductions at the MTD

    Measured: continuous

  3. The Prevalence of Anti-tumor Activity

    Measured: continuous

  4. Pharmacodynamic Markers of Target Effect in Paired Tissue Biopsies

    Measured: continuous

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2008 (estimated)
  2. Study startJun 2008
  3. Primary completionFeb 2014
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00691210
Sponsor's protocol ID
AAAJ3001
Acronym
SAHA
Status last verified
Nov 2020
First submitted
3 Jun 2008
Last updated
20 Nov 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Amengual JE, Clark-Garvey S, Kalac M, Scotto L, Marchi E, Neylon E, Johannet P, Wei Y, Zain J, O'Connor OA. Sirtuin and pan-class I/II deacetylase (DAC) inhibition is synergistic in preclinical models and clinical studies of lymphoma. Blood. 2013 Sep 19;122(12):2104-13. doi: 10.1182/blood-2013-02-485441. Epub 2013 Aug 2.

    PubMed 23913470

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Vorinostat, Niacinamide and Etoposide in people with Hodgkin's Disease and Non-Hodgkin's Lymphoma, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Maximum Tolerated Dose (MTD) of Niacinamide in the Combination of Vorinostat and Niacinamide (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00691210, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2020.

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