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| Sponsors and Collaborators: |
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004162 |
Purpose
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 I trial to study the effectiveness of liposomal doxorubicin plus combination chemotherapy in treating patients who have AIDS-associated non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: sargramostim Drug: methotrexate Drug: pegylated liposomal doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I Trial of Liposomal Doxorubicin (Doxil) Based Combination Chemotherapy Regimen in AIDS-Associated Non-Hodgkin's Lymphoma |
| Study Start Date: | February 2000 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Alabama | |
| University of Alabama Comprehensive Cancer Center | |
| Birmingham, Alabama, United States, 35294 | |
| Study Chair: | Mansoor N. Saleh, MD | Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham |
More Information
| Study ID Numbers: | CDR0000067402, UAB-9708, UAB-F970529007, NCI-G99-1627 |
| Study First Received: | December 10, 1999 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004162 History of Changes |
| Health Authority: | United States: Federal Government |
|
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 |
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Anti-Inflammatory Agents Antimetabolites Prednisone Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Lymphoblastic Lymphoma Hormones Lymphoma, Large-cell, Immunoblastic Lymphoma, Small Cleaved-cell, Diffuse Anti-Bacterial Agents Lymphoma, Large-Cell, Immunoblastic Methotrexate Lymphoma, Large-cell Lymphoma |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Antineoplastic Agents, Hormonal Vincristine Antimitotic Agents Small Non-cleaved Cell Lymphoma Folic Acid Antagonists Immunosuppressive Agents Glucocorticoids Doxorubicin Folic Acid Lymphatic Diseases Tubulin Modulators Lymphoproliferative Disorders Lymphoma, Non-Hodgkin |
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Anti-Inflammatory Agents Antimetabolites Prednisone Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Reproductive Control Agents Antibiotics, Antineoplastic Hormones Therapeutic Uses Abortifacient Agents Methotrexate |
Lymphoma Dermatologic Agents Nucleic Acid Synthesis Inhibitors Immunoproliferative Disorders Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Vincristine Enzyme Inhibitors Antimitotic Agents Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Glucocorticoids Immunosuppressive Agents |
