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Phase I Trial of Liposomal Doxorubicin (Doxil) Based Combination Chemotherapy Regimen in AIDS-Associated Non-Hodgkin's Lymphoma


Phase 1
18 Years
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

Phase I Trial of Liposomal Doxorubicin (Doxil) Based Combination Chemotherapy Regimen in AIDS-Associated Non-Hodgkin's Lymphoma


OBJECTIVES: I. Determine the toxicity and maximum tolerated dose of doxorubicin HCl liposome
when administered with combination chemotherapy in patients with AIDS-associated
non-Hodgkin's lymphoma. II. Determine the optimal phase II dose of doxorubicin HCl liposome
to be administered with the combination chemotherapy regimen. III. Determine the effect of
this regimen on HIV viral load in these patients. IV. Determine the clinical response to
this regimen by these patients.

OUTLINE: This is a dose escalation study of doxorubicin HCl liposome. Patients are
stratified by risk group (good vs poor). Patients receive doxorubicin HCl liposome IV,
vincristine IV, and methotrexate intrathecally on day 1, followed by oral prednisone on days
1-5. Sargramostim (GM-CSF) is administered subcutaneously on days 5-14 until blood counts
recover. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of
doxorubicin HCl liposome until the maximum tolerated dose (MTD) is determined. The MTD is
defined as the dose at which 2 of 6 patients experience dose limiting toxicity. Patients are
followed every 3 months for 1 year, every 6 months for 2 years, and then annually
thereafter.

PROJECTED ACCRUAL: A minimum of 42-48 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically proven good or poor prognosis AIDS-associated
non-Hodgkin's lymphoma expressing CD20 antigen HIV positive Stage II-IV Good risk patients
are defined as: Karnofsky 80-100% No prior history of AIDS defining illness No bone marrow
involvement with lymphoma No clinical, radiographic, or cytologic evidence of CNS lymphoma
Bidimensionally measurable disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Life
expectancy: At least 3 months Hematopoietic: Absolute neutrophil count greater than
1,000/mm3 Platelet count greater than 75,000/mm3 Hemoglobin greater than 9 g/dL Hepatic:
Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT or SGPT less than 5
times ULN Alkaline phosphatase less than 5 times ULN Renal: Creatinine no greater than 1.5
times ULN Other: Not pregnant No active opportunistic or any other serious infection No
other malignancy (including any other AIDS-associated malignancy) except stable cutaneous
Kaposi's sarcoma No serious medical or psychiatric condition

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
doxorubicin or doxorubicin HCl liposome No prior chemotherapy for non-Hodgkin's lymphoma,
except single dose of intrathecal chemotherapy at time of staging lumbar puncture
Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: At least 2 weeks
since major surgery Other: No concurrent treatment for Kaposi's sarcoma Concurrent
antiretroviral therapy allowed

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the toxicity and maximum tolerated dose of doxorubicin HCl liposome when administered with combination chemotherapy in patients with AIDS-associated non-Hodgkin's lymphoma.

Outcome Time Frame:

baseline to last dose of study drug

Safety Issue:

Yes

Principal Investigator

Mansoor N. Saleh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Federal Government

Study ID:

CDR0000067402

NCT ID:

NCT00004162

Start Date:

June 1997

Completion Date:

January 2001

Related Keywords:

  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294