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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Tyler Martin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Systemix

Authority:

United States: Federal Government

Study ID:

CDR0000067135

NCT ID:

NCT00003942

Start Date:

November 1998

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Cedars-Sinai Medical CenterLos Angeles, California  90048
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Division of OncologyPalo Alto, California  94304