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Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients with HIV Associated Large Cell and Immunoblastic Lymphomas



Phase II Study of Novantrone(R) (Mitoxantrone) and Etoposide in Patients with HIV Associated Large Cell and Immunoblastic Lymphomas

For Condition: Lymphoma, Non-Hodgkin,HIV Infections
Status: Completed
Sponsor(s): Lederle Laboratories ,
Synopsis: To determine the efficacy and toxicity of the combination of mitoxantrone hydrochloride ( Novantrone ) and etoposide in the treatment of patients with HIV associated lymphomas.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Dose Comparison, Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria 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. Exclusion Criteria 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. - 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.
Total Enrollment: 

Location and Contact Information:

Saint Luke's - Roosevelt Hosp Ctr
New York City,  New York,  10019
United States
 

UMDNJ - New Jersy Med School
Newark,  New Jersey,  071032714
United States
 

New York Univ Med Ctr
New York City,  New York,  10016
United States
 


Additional Information:
Study ID Numbers:
  055A;  3-100
Study Start Date: 
Record last reviewed: March 1992
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002003

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4. Meaning-Centered Psychotherapy in Advanced Cancer

5. Proleukin in Combination with Rituxan in Patients with Low-Grade Non-Hodgkin's Lymphoma Who Have Previously Failed Rituxan Treatments

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