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

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Systemix
Information provided by: National Cancer Institute (NCI)

Purpose

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.

Condition Treatment or Intervention Phase
AIDS-related diffuse small cleaved cell lymphoma
AIDS-related small noncleaved cell lymphoma
AIDS-related lymphoblastic lymphoma
AIDS-related diffuse mixed cell lymphoma
AIDS-related immunoblastic large cell lymphoma
AIDS-related peripheral/systemic lymphoma
AIDS-related diffuse large cell lymphoma
 Drug: RevM10 gene
 Drug: RevM10/polAS gene
Phase I
Phase II

MedlinePlus related topics:  Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I/II Study of RevM10 or RevM10/Antisense POL 1 Transduced Hematopoietic Stem Cells in Patients with HIV-1 Related Non-Hodgkin's Lymphoma Receiving High Dose Chemotherapy amd Peripheral Blood Stem Cell Support

Further Study Details: 

Study start: November 1998

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.

PROTOCOL 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.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--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

--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

Location Information


Alabama
      University of Alabama Comprehensive Cancer Center, Birmingham,  Alabama,  35294,  United States

California
      Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States

      Division of Oncology, Palo Alto,  California,  94304,  United States

      Jonsson Comprehensive Cancer Center, UCLA, Los Angeles,  California,  90095-1781,  United States

Massachusetts
      Massachusetts General Hospital Cancer Center, Boston,  Massachusetts,  02114,  United States

Nebraska
      University of Nebraska Medical Center, Omaha,  Nebraska,  68198-3330,  United States

Study chairs or principal investigators

Tyler Martin,  Study Chair,  Systemix   

More Information

Clinical trial summary from the National Cancer Institute's PDQ®

Study ID Numbers:  CDR0000067135; SYSTEMIX-105; NCI-G99-1549; UCLA-HSPC-980303601D
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003942
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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