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Gene Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma

Primary Purpose

Lymphoma

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
RevM10 gene
RevM10/polAS gene
in vitro-treated peripheral blood stem cell transplantation
peripheral blood stem cell transplantation
Sponsored by
Systemix
About
Eligibility
Locations
Outcomes
Full info

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, AIDS-related diffuse mixed cell lymphoma, AIDS-related diffuse small cleaved cell lymphoma, AIDS-related lymphoblastic lymphoma

Eligibility Criteria

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

DISEASE CHARACTERISTICS: HIV-1 infection documented by ELISA and Western blot Histologically proven non-Hodgkin's lymphoma showing at least partial response to standard chemotherapy regimen Poor prognosis in first chemotherapy induced remission Increased LDH AND/OR Stage III or IV AND/OR Reduced performance status (ECOG 2 or worse) OR Response but no complete remission following four courses of standard chemotherapy OR Responding relapse after primary therapy No primary CNS lymphoma No uncontrolled meningeal lymphoma at mobilization PATIENT CHARACTERISTICS: Age: 18 and over Performance status: See Disease Characteristics Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 CD4 count at least 100/mm3 Hepatic: Bilirubin less than 2 mg/dL (unless taking indinavir) SGOT and SGPT less than 2 times normal No hepatitis Renal: Creatinine less than 2.0 mg/dL Pulmonary: DLCO greater than 60% Other: Not pregnant or nursing Fertile patients must use effective contraception No active Mycobacterium avium-intracellulare infection or CMV disease No cerebral toxoplasmosis or cryptococcal meningitis At least 6 months since prior alcohol or substance abuse At least 1 year since CNS disease or seizures No other medical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No concurrent chemotherapy for Kaposi's sarcoma Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 30 days since prior treatment for serious opportunistic infections

Sites / Locations

  • University of Alabama Comprehensive Cancer Center
  • Cedars-Sinai Medical Center
  • Jonsson Comprehensive Cancer Center, UCLA
  • Division of Oncology
  • Massachusetts General Hospital Cancer Center
  • University of Nebraska Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
December 3, 2013
Sponsor
Systemix
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00003942
Brief Title
Gene Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma
Official Title
A Phase I/II Study of the Safety and Feasibility of REVM10 or REVM10/ANTISENSE POL 1 Transduced Hematopoietic Stem Cells (HSC) in HIV-1 Related Non-Hodgkin's Lymphoma Patients Already Being Treated With High Dose Chemotherapy and Peripheral Blood Stem Cell Support
Study Type
Interventional

2. Study Status

Record Verification Date
August 2000
Overall Recruitment Status
Unknown status
Study Start Date
November 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Systemix
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Inserting the gene for RevM10 into a person's peripheral stem cells may improve the body's ability to fight cancer or make the cancer more sensitive to chemotherapy. PURPOSE: Phase I/II trial to study the effectiveness of RevM10-treated stem cells plus chemotherapy and peripheral stem cell transplantation in treating patients who have HIV-related non-Hodgkin's lymphoma.
Detailed Description
OBJECTIVES: I. Determine the safety of infusion of RevM10 or RevM10/polAS transduced hematopoietic stem cells (HSC) in addition to high dose chemotherapy and standard peripheral blood stem cell support in patients with HIV-1 related non-Hodgkin's lymphoma. II. Determine gene marking of lymphocytes and myeloid cells in peripheral blood, bone marrow, and/or lymph nodes after infusion of RevM10-HSC or RevM10/polAS-HSC in these patients. III. Determine the antiretroviral effect of this treatment in these patients. OUTLINE: This is a multicenter study. Patients receive mobilization therapy and undergo leukapheresis according to a standard protocol. High dose chemotherapy is administered on days -7 to -1, also according to a standard protocol. On day 0, autologous hematopoietic stem cells transduced with genes RevM10 or RevM10/polAS are infused. Unmodified autologous peripheral blood stem cells are reinfused on day 1. Patients are followed daily for 2 weeks, weekly for 2 weeks, monthly for 1 year, then annually thereafter. PROJECTED ACCRUAL: Approximately 15 patients will be accrued for this study within 14 months.

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, 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 1, Phase 2
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
RevM10 gene
Intervention Type
Biological
Intervention Name(s)
RevM10/polAS gene
Intervention Type
Procedure
Intervention Name(s)
in vitro-treated peripheral blood stem cell transplantation
Intervention Type
Procedure
Intervention Name(s)
peripheral blood stem cell transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: HIV-1 infection documented by ELISA and Western blot Histologically proven non-Hodgkin's lymphoma showing at least partial response to standard chemotherapy regimen Poor prognosis in first chemotherapy induced remission Increased LDH AND/OR Stage III or IV AND/OR Reduced performance status (ECOG 2 or worse) OR Response but no complete remission following four courses of standard chemotherapy OR Responding relapse after primary therapy No primary CNS lymphoma No uncontrolled meningeal lymphoma at mobilization PATIENT CHARACTERISTICS: Age: 18 and over Performance status: See Disease Characteristics Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1500/mm3 Platelet count at least 100,000/mm3 CD4 count at least 100/mm3 Hepatic: Bilirubin less than 2 mg/dL (unless taking indinavir) SGOT and SGPT less than 2 times normal No hepatitis Renal: Creatinine less than 2.0 mg/dL Pulmonary: DLCO greater than 60% Other: Not pregnant or nursing Fertile patients must use effective contraception No active Mycobacterium avium-intracellulare infection or CMV disease No cerebral toxoplasmosis or cryptococcal meningitis At least 6 months since prior alcohol or substance abuse At least 1 year since CNS disease or seizures No other medical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No concurrent chemotherapy for Kaposi's sarcoma Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: At least 30 days since prior treatment for serious opportunistic infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tyler Martin, MD
Organizational Affiliation
Systemix
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama Comprehensive Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Jonsson Comprehensive Cancer Center, UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States
Facility Name
Division of Oncology
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-3330
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Gene Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma

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