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LymphomaPhase 1/2NCT01528865

Safety & Efficacy of Lamivudine & Tenofovir to Lower Plasma Level of Viral RNA in Lymphoma

A Phase 1/2 study testing Lamivudine and Tenofovir disoproxil fumarate in people with Lymphoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Therapy for non-Hodgkin lymphoma (NHL) is in evolution as new molecular pathways and targeted therapies are identified. Although most NHLs respond to currently available therapies, the majority of patients relapse and many never have a complete response to therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
Lamivudine and Tenofovir disoproxil fumarate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Dec 2015to Aug 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • Patients must have a histologically confirmed diagnosis of non-Hodgkin lymphoma (NHL)
  • Must have HERV-K(HML2) viral load of ≥1x103 using a gag primer reverse transcriptase polymerase chain reaction (RT-PCR) assay.
  • Must have bi-dimensionally measurable disease.
  • Patients with lymphomas that are felt to be incurable with any therapy and for whom there are no standard treatments that would be anticipated to be necessary or beneficial within the next 5 months. These patients can have received any amount of prior chemotherapy to enter this trial.
  • All previous therapies must have been discontinued at least 4 weeks prior to initiation of the administration of this study's drugs.
  • HIV negative by standard blood testing.
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  • Have an expected life expectancy of at least 5 months.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance scale status of 0 - 2l) Must have a serum creatinine <2.0 and creatinine clearance >30 ml/min/m2. Other organ dysfunction is eligible at the discretion of the PI.
  • Agree to use a reliable method of birth control prior to drug initiation and for the duration of their study participation.

Who cannot join

  • a) Have received chemotherapy or radiotherapy within 4 weeks
  • Have not recovered from the adverse effects or toxicities of lymphoma therapy most recently administered.
  • Currently receiving any other investigational medication or therapy.
  • Patients with a second malignancy that might interfere with interpretation of the results of this study.
  • Patients with known allergic reaction to lamivudine or tenofovir disoproxil fumarate (DF).
  • Patients on drugs that interfere with renal function or drugs that compete with tenofovir for active binding sites (i.e. intravenous cidofovir, acyclovir, ganciclovir, and valganciclovir).
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  • Uncontrolled concurrent illnesses, including, but not limited to, active/ongoing infection, symptomatic congestive heart failure, unstable angina pectoris.
  • Women who are pregnant, become pregnant, or are breast-feeding.
  • Standard blood tests that are positive for HIV infection

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan Comprehensive Cancer Center

    Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: A Phase I/II Study of Safety and Efficacy of Lamivudine (EPIVIR®) and Tenofovir Disoproxil Fumarate (VIREAD®) Used to Lower the Plasma Level of Viral RNA of HERV-K(HML2) in Patients With Lymphoma

Therapy for non-Hodgkin lymphoma (NHL) is in evolution as new molecular pathways and targeted therapies are identified. Although most NHLs respond to currently available therapies, the majority of patients relapse and many never have a complete response to therapy. In the investigators attempts to further understand the pathogenesis of NHLs, the investigators have identified and characterized expression of human endogenous retroviruses (HERVs) at the DNA, RNA and protein levels in association with the presence of NHLs (and other neoplastic diseases). The investigators preclinical evidence suggests a correlation with the level of HERV-K (a particular family of HERVs) expression and NHL disease activity, leading us to hypothesize that HERV-K expression may contribute to the development of the disease and/or to its recurrence. If this hypothesis is correct, then drugs that inhibit HERV-K expression may prevent recurrence of disease and/or may provide a novel therapeutic approach for NHLs.

To test this hypothesis, the investigators eventually intend to study the use of anti-retroviral therapies in patients with NHL. The investigators in vitro studies have demonstrated that HERV-K expression decreases in response to the currently FDA-approved and available, anti-HIV drugs, Lamivudine and tenofovir disoproxil fumarate (tenofovir). These medications are tolerated well in HIV patients, but it is unknown how the combination of Lamivudine and Tenofovir will be tolerated by patients with NHL. To further test the investigators hypotheses, the investigators propose the following Specific Aims of the current study: (1) To evaluate the tolerability, toxicity and safety of administering Lamivudine and Tenofovir in combination to patients with relapsed or refractory NHL; (2) To evaluate the effects of the combination of lamivudine and tenofovir on HERV-K plasma viral RNA load; and (3) To monitor the response rate of the NHL to treatment with the combination of lamivudine and tenofovir.

The investigators study will recruit adult patients with relapsed or refractory NHL whom the investigators have identified as having expression of HERV-K. Volunteer participants will be administered the combination of lamivudine and tenofovir and monitored for tolerability, toxicity, compliance, changes in viral RNA load and disease response.

Conditions
Lymphoma
Being tested
Lamivudine, Tenofovir disoproxil fumarate
Keywords
virus, K(HML2)[HERV-K(HML2)], Lymphoma, Human endogenous retrovirus-K(HLM2)[HERV-K(HML2)]
Medical subject headings
Lymphoma, Virus Diseases

What participants receive

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

  • LamivudineDrug

    Also called Epivir

    Creatinine Clearance (mL/min): ≥50, Recommended Dosage of Epivir: 150 mg twice daily or 300 mg once daily.

    Creatinine Clearance (mL/min): 30-49, Recommended Dosage of Epivir: 150 mg once daily.

    Subjects will be taking drug for 16 weeks.

  • Tenofovir disoproxil fumarateDrug

    Also called Viread

    300 mg once a day p.o. for 16 weeks.

Study groups in NCT01528865
Study groupRoleWhat they receive
Study DrugsExperimentalThe medications to be used in this study are Lamivudine (EPIVIR®) and Tenofovir disoproxil fumarate (VIREAD®), medications already used in people with certain other types of viruses [but not HERV-K(HML2)] in their body. Treatment will last 16 weeks. This is an experiment combining these two drugs and has been issue an Investigational New Drug (IND) Exemption by the FDA.
Receives: Drug: Lamivudine; Drug: Tenofovir disoproxil fumarate

What is being measured

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

  1. Efficacy (effect on human endogenous retrovirus-K(HML2)[HERV-K(HML2)]

    Patients will have HERV-K(HML2) viral load measured at baseline and post-treatment (quantifiable HERV-K(HML2) viral load is an eligibility criterion, and post-treatment loads below the limit of quantitation will be assigned a random value uniformly distributed between 0 and the limit of quantitation).

    Measured: 2 years

Secondary outcomes (2)

  1. tumor regression

    Linear models will be used to relate tumor regression to change in viral load of RNA levels.

    Measured: 2 years

  2. Toxicity will be tabulated according to NCI NCI Common Terminology Criteria for Adverse Events (CTCAE) v4 grade and classification

    Measured: 2 years

Timeline

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

  1. First posted8 Feb 2012 (estimated)
  2. Study startDec 2015
  3. Primary completionAug 2017 (estimated)

Why it stopped: Funding was removed.

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 1/2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01528865
Sponsor's protocol ID
UMCC 2010 097
Other IDs
HUM 33361
Status last verified
Mar 2016
First submitted
12 Jan 2012
Last updated
11 Mar 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Lamivudine and Tenofovir disoproxil fumarate in people with Lymphoma, run by University of Michigan Rogel Cancer Center 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 9 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: withdrawn, as of the sponsor's last update on 11 Mar 2016. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Efficacy (effect on human endogenous retrovirus-K(HML2)[HERV-K(HML2)] (time frame: 2 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 NCT01528865.

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 11 Mar 2016.

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