Lymphoma, Non-HodgkinPhase 2NCT00002003
Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients With HIV Associated Large Cell and Immunoblastic Lymphomas
A Phase 2 study testing Mitoxantrone hydrochloride and Etoposide in people with Lymphoma, Non-Hodgkin and HIV Infections, run by Lederle Laboratories at 3 sites in United States.
Trial summary
To determine the efficacy and toxicity of the combination of mitoxantrone hydrochloride ( Novantrone ) and etoposide in the treatment of patients with HIV associated lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin, HIV Infections
- What is being tested?
- Mitoxantrone hydrochloride and Etoposide
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
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 the following:
- Positive HIV antibody, positive HIV culture or antigen capture, or prior diagnosis of AIDS by the CDC criteria.
- Diagnosis by pathological examination of large cell or immunoblastic lymphoma within measurable or evaluable disease.
- Pneumocystis carinii pneumonia (PCP) prophylaxis during the course of the study.
- Signed written informed consent.
Who cannot join
- Co-existing Condition:
- Patients with the following conditions or symptoms are excluded:
- Acute intercurrent opportunistic infection, such as Pneumocystis carinii pneumonia (PCP) diagnosed within 3 weeks.
- Stage IE Central Nervous System lymphomas.
- Patients with the following are excluded:
- More than one previous treatment for lymphoma.
Show all 20Show fewer
- Acute intercurrent opportunistic infection, such as Pneumocystis carinii pneumonia (PCP) diagnosed within 3 weeks.
- Conditions that preclude obtaining an informed consent.
- Not accessible for scheduled treatment visits or follow-up.
- Stage IE Central Nervous System (CNS) lymphomas.
- Prior Medication:
- Excluded within 2 weeks of study entry:
- Zidovudine.
- Excluded:
- Doxorubicin dosing = or > 300 mg/m2.
- Prior Treatment:
- Excluded:
- Received more than one previous treatment regimen for lymphoma.
- Required:
- Prophylactic treatment for Pneumocystis carinii pneumonia (PCP) prophylaxis.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New York Univ Med Ctr
New York, New York, 10016
Saint Luke's - Roosevelt Hosp Ctr
New York, New York, 10019
UMDNJ - New Jersy Med School
Newark, New Jersey, 071032714
About this study
To determine the efficacy and toxicity of the combination of mitoxantrone hydrochloride ( Novantrone ) and etoposide in the treatment of patients with HIV associated lymphomas.
- Conditions
- Lymphoma, Non-Hodgkin, HIV Infections
- Being tested
- Mitoxantrone hydrochloride, Etoposide
- Keywords
- Mitoxantrone, Lymphoma, Large-Cell, Etoposide, Acquired Immunodeficiency Syndrome
- Medical subject headings
- Lymphoma, Non-Hodgkin, HIV Infections, Dendritic Cell Sarcoma, Interdigitating, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone hydrochlorideDrug
EtoposideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Lederle Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002003
- Sponsor's protocol ID
- 055A
- Other IDs
- 3-100
- Status last verified
- Mar 1992
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No