Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory AIDS-Related Lymphoma

Back to results

Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

filgrastim

busulfan

cyclophosphamide

peripheral blood stem cell transplantation

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring AIDS-related peripheral/systemic lymphoma, AIDS-related diffuse large cell lymphoma, AIDS-related immunoblastic large cell lymphoma, AIDS-related small noncleaved cell lymphoma, HIV-associated Hodgkin lymphoma, AIDS-related diffuse mixed cell lymphoma, AIDS-related diffuse small cleaved cell lymphoma, AIDS-related lymphoblastic lymphoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Intermediate- or high-grade non-Hodgkin's lymphoma or Hodgkin's disease Failed to achieve complete remission with initial therapy OR Relapsed after initial therapy May be in complete remission after salvage therapy Sensitive to most recent chemotherapy Improvement of at least 25% in bidimensional tumor measurements OR Improvement in evaluable disease sustained over 4 weeks Measurable or evaluable disease HIV-1 positive CD4 greater than 50 cells/mm^3 (unless not receiving optimal antiretroviral therapy) HIV RNA less than 110,000 copies/mL (unless not receiving optimal antiretroviral therapy) No active leptomeningeal or parenchymal CNS involvement NOTE: 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: Physiologic 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,000/mm^3 Hepatic: AST no greater than 3 times upper limit of normal Bilirubin no greater than 2.0 mg/dL (unless receiving indinavir) Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No history of cardiac disease LVEF at least 45% Pulmonary: No history of symptomatic pulmonary disease DLCO at least 60% Other: No active opportunistic infections No cytomegalovirus retinitis or pneumonitis requiring maintenance therapy No sensitivity to E. coli-derived products Not pregnant Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 1 week since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: Chronic suppressive therapy for infection allowed

Sites / Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Massachusetts General Hospital Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00005824

First Posted

June 2, 2000

Last Updated

February 1, 2016

Sponsor

AIDS Malignancy Consortium

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00005824

Brief Title

Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Refractory AIDS-Related Lymphoma

Official Title

Pilot Study of the Safety and Feasibility of Autologous Peripheral Blood Stem Cell Transplantation for Patients With Relapsed AIDS-Related Lymphoma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Completed

Study Start Date

November 2000 (undefined)

Primary Completion Date

July 2004 (Actual)

Study Completion Date

April 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AIDS Malignancy Consortium

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation in treating patients who have recurrent or refractory AIDS-related lymphoma.

Detailed Description

OBJECTIVES: Determine the safety and tolerability of intensive chemotherapy and autologous peripheral blood stem cell transplantation in patients with recurrent or refractory AIDS-related lymphoma. Determine the response and response duration in these patients treated with this regimen. Determine the effect of this treatment regimen on HIV RNA and CD4 cells in these patients. OUTLINE: Patients receive mobilization chemotherapy consisting of cyclophosphamide IV over 2 hours followed 2 days later by daily filgrastim (G-CSF) subcutaneously (SC) until blood counts recover. Patients then undergo leukopheresis to collect CD34+ cells. Patients receive conditioning chemotherapy consisting of oral busulfan every 6 hours on days -7, -6, -5, and -4 for a total of 14 doses and cyclophosphamide IV over 1 hour on days -3 and -2. Patients undergo autologous stem cell infusion on day 0. G-CSF is administered IV or SC daily beginning on day 1 and continuing until blood counts recover. Patients are followed monthly for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 5-25 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

AIDS-related peripheral/systemic lymphoma, AIDS-related diffuse large cell lymphoma, AIDS-related immunoblastic large cell lymphoma, AIDS-related small noncleaved cell lymphoma, HIV-associated Hodgkin lymphoma, AIDS-related diffuse mixed cell lymphoma, AIDS-related diffuse small cleaved cell lymphoma, AIDS-related lymphoblastic lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Masking

None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

filgrastim

Intervention Type

Drug

Intervention Name(s)

busulfan

Intervention Type

Drug

Intervention Name(s)

cyclophosphamide

Intervention Type

Procedure

Intervention Name(s)

peripheral blood stem cell transplantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Intermediate- or high-grade non-Hodgkin's lymphoma or Hodgkin's disease Failed to achieve complete remission with initial therapy OR Relapsed after initial therapy May be in complete remission after salvage therapy Sensitive to most recent chemotherapy Improvement of at least 25% in bidimensional tumor measurements OR Improvement in evaluable disease sustained over 4 weeks Measurable or evaluable disease HIV-1 positive CD4 greater than 50 cells/mm^3 (unless not receiving optimal antiretroviral therapy) HIV RNA less than 110,000 copies/mL (unless not receiving optimal antiretroviral therapy) No active leptomeningeal or parenchymal CNS involvement NOTE: 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: Physiologic 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count greater than 1,000/mm^3 Hepatic: AST no greater than 3 times upper limit of normal Bilirubin no greater than 2.0 mg/dL (unless receiving indinavir) Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No history of cardiac disease LVEF at least 45% Pulmonary: No history of symptomatic pulmonary disease DLCO at least 60% Other: No active opportunistic infections No cytomegalovirus retinitis or pneumonitis requiring maintenance therapy No sensitivity to E. coli-derived products Not pregnant Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 1 week since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: Chronic suppressive therapy for infection allowed

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David T. Scadden, MD

Organizational Affiliation

Massachusetts General Hospital

Official's Role

Study Chair

Facility Information:

Facility Name

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21231

Country

United States

Facility Name

Massachusetts General Hospital Cancer Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02129

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18158962

Citation

Spitzer TR, Ambinder RF, Lee JY, Kaplan LD, Wachsman W, Straus DJ, Aboulafia DM, Scadden DT. Dose-reduced busulfan, cyclophosphamide, and autologous stem cell transplantation for human immunodeficiency virus-associated lymphoma: AIDS Malignancy Consortium study 020. Biol Blood Marrow Transplant. 2008 Jan;14(1):59-66. doi: 10.1016/j.bbmt.2007.03.014.

Results Reference

result

Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial