Lymphoma Clinical Trial
Official title:
A Phase II Study of Doxil (Liposomal Doxorubicin), Cyclophosphamide, Vincristine and Prednisone for AIDS-Related Systemic Lymphoma
NCT number | NCT00003388 |
Other study ID # | CDR0000066385 |
Secondary ID | E-3D97 |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | July 26, 1999 |
Verified date | June 2023 |
Source | Eastern Cooperative Oncology Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy consisting of liposomal doxorubicin, cyclophosphamide, vincristine, and prednisone in treating patients with AIDS-related lymphoma.
Status | Completed |
Enrollment | 38 |
Est. completion date | |
Est. primary completion date | April 2003 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Albert Einstein Comprehensive Cancer Center | Bronx | New York |
United States | MBCCOP-Our Lady of Mercy Cancer Center | Bronx | New York |
United States | Veterans Affairs Medical Center - Palo Alto | Palo Alto | California |
United States | Raritan Bay Medical Center | Perth Amboy | New Jersey |
United States | Stanford University Medical Center | Stanford | California |
Lead Sponsor | Collaborator |
---|---|
Eastern Cooperative Oncology Group | National Cancer Institute (NCI) |
United States,
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