Combination Chemotherapy in Treating Patients With AIDS-Related Lymphoma

Sponsor

Eastern Cooperative Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00003388

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

7.6

Patients Per Site

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Biological: filgrastim Drug: cyclophosphamide Drug: cytarabine Drug: methotrexate Drug: pegylated liposomal doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Radiation: radiation therapy	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

38 participants

Primary Purpose:

Treatment

Official Title:

A Phase II Study of Doxil (Liposomal Doxorubicin), Cyclophosphamide, Vincristine and Prednisone for AIDS-Related Systemic Lymphoma

Study Start Date :

Feb 1, 1999

Actual Primary Completion Date :

Apr 1, 2003

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Veterans Affairs Medical Center - Palo Alto	Palo Alto	California	United States	94304
2	Stanford University Medical Center	Stanford	California	United States	94305-5408
3	Raritan Bay Medical Center	Perth Amboy	New Jersey	United States	08861
4	Albert Einstein Comprehensive Cancer Center	Bronx	New York	United States	10461
5	MBCCOP-Our Lady of Mercy Cancer Center	Bronx	New York	United States	10466