NCT00003942

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at P25-P50 for phase_1 lymphoma

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 1998

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
4.7 years until next milestone

First Posted

Study publicly available on registry

July 26, 2004

Completed
Last Updated

December 4, 2013

Status Verified

August 1, 2000

First QC Date

November 1, 1999

Last Update Submit

December 3, 2013

Conditions

Lymphoma

Keywords

AIDS-related peripheral/systemic lymphomaAIDS-related diffuse large cell lymphomaAIDS-related immunoblastic large cell lymphomaAIDS-related small noncleaved cell lymphomaAIDS-related diffuse mixed cell lymphomaAIDS-related diffuse small cleaved cell lymphomaAIDS-related lymphoblastic lymphoma

Interventions

RevM10 geneBIOLOGICAL
RevM10/polAS geneBIOLOGICAL
in vitro-treated peripheral blood stem cell transplantationPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (6)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Jonsson Comprehensive Cancer Center, UCLA

Los Angeles, California, 90095-1781, United States

Location

Division of Oncology

Palo Alto, California, 94304, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-3330, United States

Location

MeSH Terms

Conditions

Lymphoma

Interventions

Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Hematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Tyler Martin, MD

    Systemix

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 1, 1999

First Posted

July 26, 2004

Study Start

November 1, 1998

Last Updated

December 4, 2013

Record last verified: 2000-08

Locations

US(6)