Antiviral Therapy Plus Either Peripheral Stem Cell or Umbilical Cord Blood Transplantation in Treating Patients Who Are HIV Positive and Have Hematologic Cancer

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Primary Purpose

Status

Withdrawn

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

anti-thymocyte globulin

melphalan

antiviral therapy

bone marrow ablation with stem cell support

peripheral blood stem cell transplantation

umbilical cord blood transplantation

radiation therapy

About this trial

This is an interventional treatment trial for Leukemia focused on measuring recurrent adult acute lymphoblastic leukemia, secondary acute myeloid leukemia, AIDS-related peripheral/systemic lymphoma, HIV-associated Hodgkin lymphoma

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed intermediate or high grade non-Hodgkin's lymphoma, acute myelogenous leukemia, or acute lymphocytic leukemia that is refractory to or relapsed after prior therapy Must be HIV seropositive confirmed by Western blot Must have a 6/6 HLA matched sibling donor or 6/6, 5/6, or 4/6 HLA matched umbilical cord blood (UCB) from the New York Blood Center's Unrelated UCB Bank that is not homozygous for the CCR-5 mutation No active primary CNS lymphoma or chronic CNS infection No history of AIDS defining opportunistic infection or active invasive aspergillus infection 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 to 55 Performance status: Karnofsky 70-100% Life expectancy: At least 6 months (unless due to hematologic malignancy) Hematopoietic: Peripheral CD4 count greater than 100/mm3 Hepatic: Transaminases no greater than 4 times normal Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No myocardial infarction within the past 6 months Normal cardiac function (LVEF greater than 40%) Pulmonary: FVC and FEV1 greater than 70% of predicted DLCO at least 60% of predicted Other: No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix within the past 5 years Not pregnant (must have negative pregnancy test within 2 weeks of therapy) PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow, peripheral blood stem cell, or umbilical cord blood transplant Chemotherapy: Cumulative lifetime dose of doxorubicin no greater than 450 mg/m2 (or equivalent dose of mitoxantrone or daunorubicin) Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent involvement in any other clinical trial that may affect hematologic engraftment

Sites / Locations

Duke Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00003435

First Posted

November 1, 1999

Last Updated

March 6, 2013

Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00003435

Brief Title

Antiviral Therapy Plus Either Peripheral Stem Cell or Umbilical Cord Blood Transplantation in Treating Patients Who Are HIV Positive and Have Hematologic Cancer

Official Title

A Pilot Study Involving Administration of Combination Anti-Retroviral Therapy and Transplantation of HLA-Matched Sibling Peripheral Blood Stem Cells or Partially HLA-Matched Unrelated Umbilical Cord Blood In Adults With HIV Infection and Hematologic Malignancies

Study Type

Interventional

2. Study Status

Record Verification Date

December 2000

Overall Recruitment Status

Withdrawn

Study Start Date

May 1998 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Duke University

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Antiviral agents are drugs that act against viruses and may be an effective treatment for HIV. Peripheral stem cell transplantation or umbilical cord blood transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill tumor cells. Combining either umbilical cord blood transplantation or peripheral stem cell transplantation with antiviral therapy may be an effective treatment for HIV-positive patients who have hematologic cancer. PURPOSE: Phase I trial to study the effectiveness of antiviral therapy plus either peripheral stem cell transplantation or umbilical cord blood transplantation in treating HIV-positive patients who have refractory or recurrent hematologic cancer.

Detailed Description

OBJECTIVES: I. Determine the feasibility and safety of combination antiretroviral therapy followed by HLA matched sibling peripheral blood stem cell or unrelated umbilical cord blood transplants in HIV infected adults with hematologic malignancies. II. Measure the effects of this treatment on HIV viral burden in the serum and tissues of these patients. III. Measure immune reconstitution following treatment in this patient population. OUTLINE: Patients receive a combination of 3 antiretroviral agents beginning at least 3 weeks prior to the initiation of the myeloablative conditioning regimen. The antiretroviral agents are discontinued on days -5 to -1 prior to transplant. Beginning on day 0 the antiretroviral agents are restarted and continue indefinitely. Patients who are given umbilical cord blood (UCB) transplants undergo collection of autologous peripheral blood stem cells (PBSC) prior to the myeloablative conditioning regimen in case there is UCB graft failure. Prior to PBSC or UCB transplantation on day 0, all patients receive a myeloablative conditioning regimen. The conditioning regimen consists of total body irradiation twice a day on days -9 to -5 and melphalan IV over 60 minutes on days -4 to -2. Patients receiving UCB transplant also receive anti-thymocyte globulin over 6 hours on days -3 to -1. Patients are followed every 3 months for 3 years, then annually for the next 3 years. PROJECTED ACCRUAL: A total of 6 patients will be accrued for this study over 2 years.

6. Conditions and Keywords

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

Leukemia, Lymphoma

Keywords

recurrent adult acute lymphoblastic leukemia, secondary acute myeloid leukemia, AIDS-related peripheral/systemic lymphoma, HIV-associated Hodgkin lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

anti-thymocyte globulin

Intervention Type

Drug

Intervention Name(s)

melphalan

Intervention Type

Procedure

Intervention Name(s)

antiviral therapy

Intervention Type

Procedure

Intervention Name(s)

bone marrow ablation with stem cell support

Intervention Type

Procedure

Intervention Name(s)

peripheral blood stem cell transplantation

Intervention Type

Procedure

Intervention Name(s)

umbilical cord blood transplantation

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically confirmed intermediate or high grade non-Hodgkin's lymphoma, acute myelogenous leukemia, or acute lymphocytic leukemia that is refractory to or relapsed after prior therapy Must be HIV seropositive confirmed by Western blot Must have a 6/6 HLA matched sibling donor or 6/6, 5/6, or 4/6 HLA matched umbilical cord blood (UCB) from the New York Blood Center's Unrelated UCB Bank that is not homozygous for the CCR-5 mutation No active primary CNS lymphoma or chronic CNS infection No history of AIDS defining opportunistic infection or active invasive aspergillus infection 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 to 55 Performance status: Karnofsky 70-100% Life expectancy: At least 6 months (unless due to hematologic malignancy) Hematopoietic: Peripheral CD4 count greater than 100/mm3 Hepatic: Transaminases no greater than 4 times normal Bilirubin no greater than 2.0 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Creatinine clearance at least 60 mL/min Cardiovascular: No myocardial infarction within the past 6 months Normal cardiac function (LVEF greater than 40%) Pulmonary: FVC and FEV1 greater than 70% of predicted DLCO at least 60% of predicted Other: No other malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix within the past 5 years Not pregnant (must have negative pregnancy test within 2 weeks of therapy) PRIOR CONCURRENT THERAPY: Biologic therapy: No prior bone marrow, peripheral blood stem cell, or umbilical cord blood transplant Chemotherapy: Cumulative lifetime dose of doxorubicin no greater than 450 mg/m2 (or equivalent dose of mitoxantrone or daunorubicin) Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: No concurrent involvement in any other clinical trial that may affect hematologic engraftment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clayton Smith, MD

Organizational Affiliation

Duke Cancer Institute

Official's Role

Study Chair

Facility Information:

Facility Name

Duke Comprehensive Cancer Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Leukemia, 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

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