A Phase II Study of Doxil (Liposomal Doxorubicin), Cyclophosphamide, Vincristine and Prednisone for AIDS-Related Systemic Lymphoma
18 Years
N/A
Both
Lymphoma
Trial Information
A Phase II Study of Doxil (Liposomal Doxorubicin), Cyclophosphamide, Vincristine and Prednisone for AIDS-Related Systemic Lymphoma
OBJECTIVES: I. Determine the one year survival and complete response rate of patients
treated with doxorubicin HCl liposome/cyclophosphamide/vincristine/prednisone (Doxil-CVP)
for AIDS-related lymphoma. II. Evaluate the toxicity of a combination chemotherapy regimen,
Doxil-CVP, in this patient population. III. Evaluate the progression free and overall
survival after treatment with Doxil-CVP in this patient population. IV. Evaluate the effects
of treatment with Doxil-CVP on plasma viral mRNA levels, CD4+ lymphocyte count, and the
incidences and types of opportunistic infections in this patient population.
OUTLINE: Patients are stratified according to disease characteristics. All patients receive
a 30 minute infusion of doxorubicin HCl liposome IV, cyclophosphamide IV, and vincristine IV
on day 1. Patients also receive oral prednisone on days 1-5. Filgrastim (G-CSF) is
administered subcutaneously starting on day 6 and continues until the absolute neutrophil
count is at least 10,000/mm3. Treatment courses are repeated every 21 days. Patients with
lymphomatous bone marrow involvement and/or category J lymphoma receive cytarabine and
methotrexate intrathecally weekly for 4 weeks. Patients with lymphomatous meningitis receive
whole brain irradiation and an alternating intrathecal chemotherapy regimen. A minimum of 4
and a maximum of 8 courses are administered. Patients are removed from the study for
progressive disease, stable disease after 4 courses, a life threatening infection that would
delay treatment for more than 6 weeks, or any delay, except due to neutropenia, in
chemotherapy treatment for more than 6 weeks. Patients who achieve a complete response
receive an additional 2 courses of therapy. Patients are followed every 3 months for 2
years, every 6 months for 3 years, and annually thereafter.
PROJECTED ACCRUAL: A total of 38 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed AIDS-related
non-Hodgkin's lymphoma of the intermediate or high grade histologic types Anaplastic large
cell lymphoma allowed Must be HIV positive Must have at least one objective measurable or
evaluable disease parameter No parenchymal CNS involvement by lymphoma (meningeal lymphoma
allowed) A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by
PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former
terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol
uses the former terminology.
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: (Except patients with lymphomatous marrow involvement)
Absolute neutrophil count at least 1000/mm3 Platelet count at least 50,000/mm3 Hepatic:
Bilirubin no greater than 5.0 mg/dL Renal: Creatinine less than 3.0 mg/dL Cardiovascular:
Patients with history of heart disease, evidence of congestive heart failure, radiographic
evidence of cardiomegaly, or electrocardiographic evidence of a prior myocardial
infarction must have LVEF at least at lower limit of normal Neurologic: No grade 3 or
greater peripheral neuropathy Other: No prior or concurrent malignancy other than Kaposi's
sarcoma, curatively treated basal cell or squamous cell carcinoma of the skin, or
curatively treated carcinoma in situ of the cervix Not pregnant or nursing Fertile
patients must use effective contraception No history of sensitivity to E. coli-derived
proteins
PRIOR CONCURRENT THERAPY: Biologic therapy: At least 5 days since interferon therapy
Chemotherapy: No prior cytotoxic chemotherapy except for mucocutaneous Kaposi's sarcoma At
least 12 months since cytotoxic chemotherapy for Kaposi's sarcoma Endocrine therapy: Prior
steroids allowed No concurrent steroid therapy greater than 5 mg prednisone (or
equivalent) per day Radiotherapy: No prior radiotherapy except for mucocutaneous Kaposi's
sarcoma Surgery: Not specified Other: No concurrent zidovudine (AZT) Concurrent
antiretroviral medications other than AZT allowed
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Matthew D. Volm, MD
Investigator Role:
Study Chair
Investigator Affiliation:
New York University School of Medicine
Authority:
United States: Food and Drug Administration
Study ID:
CDR0000066385
NCT ID:
NCT00003388
Start Date:
February 1999
Completion Date:
Related Keywords:
- Lymphoma
- AIDS-related peripheral/systemic lymphoma
- AIDS-related diffuse large cell lymphoma
- AIDS-related immunoblastic large cell lymphoma
- AIDS-related small noncleaved cell lymphoma
- AIDS-related diffuse mixed cell lymphoma
- AIDS-related diffuse small cleaved cell lymphoma
- AIDS-related lymphoblastic lymphoma
- anaplastic large cell lymphoma
- Lymphoma
- Lymphoma, AIDS-Related
Name | Location |
|---|---|
| Albert Einstein Comprehensive Cancer Center | Bronx, New York 10461 |
| Stanford University Medical Center | Stanford, California 94305-5408 |
| Veterans Affairs Medical Center - Palo Alto | Palo Alto, California 94304 |
| MBCCOP-Our Lady of Mercy Cancer Center | Bronx, New York 10466 |
| Raritan Bay Medical Center | Perth Amboy, New Jersey 08861 |
