Gene Therapy, Chemotherapy, and Peripheral Stem Cell Transplantation in Treating Patients With HIV-Related Non-Hodgkin's Lymphoma - Article
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.
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
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--
- 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
--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
Tyler Martin, Study Chair, Systemix
More Information
Clinical trial summary from the National Cancer Institute's PDQ®
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
Resources
- Central Nervous System Lymphoma, Primary (National Cancer Institute)