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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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


Inclusion Criteria:



- 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 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.

- Have an expected life expectancy of at least 5 months.

- Have an ECOG (Eastern Cooperative Oncology Group) 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.

Exclusion Criteria:

- 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 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).

- 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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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

Outcome Description:

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).

Outcome Time Frame:

2 years

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

UMCC 2010 097

NCT ID:

NCT01528865

Start Date:

May 2013

Completion Date:

August 2016

Related Keywords:

  • Lymphoma
  • virus
  • K(HML2)[HERV-K(HML2)]
  • Lymphoma
  • Human endogenous retrovirus-K(HLM2)[HERV-K(HML2)]
  • Lymphoma

Name

Location

University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752