NCT00006264

Brief Summary

RATIONALE: Antiviral drugs such as zidovudine and ganciclovir act against viruses and may be an effective treatment for HIV. Interleukin-2 may stimulate a person's white blood cells to kill lymphoma cells. Combining these treatments may be effective in treating AIDS-related primary central nervous system lymphoma. PURPOSE: Phase II trial to study the effectiveness of combining zidovudine, ganciclovir, and interleukin-2 in treating patients who have AIDS-related primary central nervous system lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Jul 2000

Shorter than P25 for phase_2 lymphoma

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2000

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2003

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
Last Updated

February 3, 2016

Status Verified

February 1, 2016

Enrollment Period

2.7 years

First QC Date

September 11, 2000

Last Update Submit

February 1, 2016

Conditions

Lymphoma

Keywords

AIDS-related primary CNS lymphoma

Interventions

aldesleukinBIOLOGICAL
ganciclovirDRUG
zidovudineDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * HIV positive * Diagnosis of central nervous system lymphoma by one of the following means: * Brain biopsy * Thallium spectroscopy scan in conjunction with CT scan or MRI after failing to improve with at least 2 weeks of antitoxoplasmosis therapy * Cerebral spinal fluid positive for Epstein Barr virus in conjunction with positive thallium spectroscopy scan * Thallium spectroscopy scan demonstrating a thallium retention index greater than 1 * Documented intracranial space occupying lesion * No systemic non-Hodgkin's lymphoma PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Absolute granulocyte count at least 1,000/mm3 * Platelet count at least 50,000/mm3 Hepatic: * Bilirubin and SGOT no greater than 3 times upper limit of normal * No major hepatic dysfunction as evidenced by encephalopathy, ascites, or varices Renal: * Creatinine clearance at least 60 mL/min Other: * No prior other malignancy within the past 5 years except carcinoma in situ of the cervix, basal cell carcinoma of the skin, or Kaposi's sarcoma not requiring systemic therapy * No active uncontrolled infection except HIV or Epstein Barr virus * No known allergy to E. coli derived products * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Concurrent corticosteroids allowed Radiotherapy: * Not specified Surgery: * Not specified

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

Sponsors & Collaborators

Study Sites (2)

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

Location

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • Aboulafia DM, Ratner L, Miles SA, Harrington WJ Jr; AIDS Associated Malignancies Clinical Trials Consortium. Antiviral and immunomodulatory treatment for AIDS-related primary central nervous system lymphoma: AIDS Malignancies Consortium pilot study 019. Clin Lymphoma Myeloma. 2006 Mar;6(5):399-402. doi: 10.3816/clm.2006.n.017.

    PMID: 16640817RESULT

MeSH Terms

Conditions

Lymphoma

Interventions

aldesleukinGanciclovirZidovudine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AcyclovirGuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsThymidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingDideoxynucleosidesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • William J. Harrington, MD

    University of Miami Sylvester Comprehensive Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK

Study Record Dates

First Submitted

September 11, 2000

First Posted

January 27, 2003

Study Start

July 1, 2000

Primary Completion

March 1, 2003

Study Completion

July 1, 2003

Last Updated

February 3, 2016

Record last verified: 2016-02

Locations

US(2)