Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma

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Primary Purpose

Status

Unknown status

Phase

Phase 2

Locations

Italy

Study Type

Interventional

Intervention

methotrexate

zidovudine

neoadjuvant therapy

radiation therapy

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring AIDS-related primary CNS lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically proven HIV-related non-Hodgkin's lymphoma of the CNS No systemic lymphoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-3 Life expectancy: Not specified Hematopoietic: WBC at least 3000/mm^3 Platelet count at least 80,000/mm^3 Hepatic: No serious impairment of liver function Renal: No serious impairment of renal function Creatinine clearance at least 40 mL/min Cardiovascular: No serious impairment of cardiac function Neurologic: Neurological functional status 0-3 Other: No prior or active CNS-opportunistic infections No AIDS dementia complex No active systemic infections PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy

Sites / Locations

Centro di Riferimento Oncologico - Aviano

Outcomes

Primary Outcome Measures

Efficacy

Toxicity

Overall survival

Secondary Outcome Measures

Full Information

NCT ID

NCT00003261

First Posted

November 1, 1999

Last Updated

September 19, 2013

Sponsor

Centro di Riferimento Oncologico - Aviano

1. Study Identification

Unique Protocol Identification Number

NCT00003261

Brief Title

Chemotherapy and Radiation Therapy in Treating Patients With HIV-Related Primary Central Nervous System Lymphoma

Official Title

Treatment of HIV-Related Primary Central Nervous System Lymphoma (HIV-PCNSL): A Phase II Trial With Neoadjuvant Chemotherapy (High-Dose Methotrexate (MTX) Plus High-Dose Zidovudine) and Radiotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

October 2001

Overall Recruitment Status

Unknown status

Study Start Date

May 1997 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Centro di Riferimento Oncologico - Aviano

4. Oversight

5. Study Description

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving methotrexate and zidovudine together with radiation therapy works in treating patients with HIV-related primary central nervous system lymphoma.

Detailed Description

OBJECTIVES: Determine the efficacy of neoadjuvant chemotherapy and radiation therapy in the treatment of HIV-related primary CNS lymphoma patients. Evaluate the toxicity and overall survival of these patients. OUTLINE: Patients receive chemotherapy consisting of high-dose methotrexate IV administered on day 1 and high-dose zidovudine IV administered on days 1-3 every 2 weeks. Patients receive 3 courses of therapy. Following chemotherapy, patients receive radiation therapy to the lesion site daily. Patients are followed every 3 months for 1 year and then every 6 months thereafter. PROJECTED ACCRUAL: This study will accrue 14 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Lymphoma

Keywords

AIDS-related primary CNS lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Enrollment

14 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

methotrexate

Intervention Type

Drug

Intervention Name(s)

zidovudine

Intervention Type

Procedure

Intervention Name(s)

neoadjuvant therapy

Intervention Type

Radiation

Intervention Name(s)

radiation therapy

Primary Outcome Measure Information:

Title

Efficacy

Title

Toxicity

Title

Overall survival

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

DISEASE CHARACTERISTICS: Histologically proven HIV-related non-Hodgkin's lymphoma of the CNS No systemic lymphoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-3 Life expectancy: Not specified Hematopoietic: WBC at least 3000/mm^3 Platelet count at least 80,000/mm^3 Hepatic: No serious impairment of liver function Renal: No serious impairment of renal function Creatinine clearance at least 40 mL/min Cardiovascular: No serious impairment of cardiac function Neurologic: Neurological functional status 0-3 Other: No prior or active CNS-opportunistic infections No AIDS dementia complex No active systemic infections PRIOR CONCURRENT THERAPY: No prior chemotherapy or radiotherapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Umberto Tirelli, MD

Organizational Affiliation

Centro di Riferimento Oncologico - Aviano

Official's Role

Study Chair

Facility Information:

Facility Name

Centro di Riferimento Oncologico - Aviano

City

Aviano

ZIP/Postal Code

33081

Country

Italy

Lymphoma

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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