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

• Sponsor: Centro di Riferimento Oncologico - Aviano (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00003261
• Collaborator: (none)
• Enrollment: 14
• Location: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: methotrexate; Drug: zidovudine; Procedure: neoadjuvant therapy; Radiation: radiation therapy	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 14 participants
• Primary Purpose: Treatment
• 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 Start Date: May 1, 1997

Outcome Measures

Primary Outcome Measures

1. Efficacy []

2. Toxicity []

3. Overall survival []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centro di Riferimento Oncologico - Aviano	Aviano		Italy	33081

Sponsors and Collaborators

• Centro di Riferimento Oncologico - Aviano

Investigators

• Study Chair: Umberto Tirelli, MD, Centro di Riferimento Oncologico - Aviano

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00003261
• Other Study ID Numbers: CDR0000066153; ITA-GICAT-POS1; EU-97018
• First Posted: Jan 27, 2003
• Last Update Posted: Sep 20, 2013
• Last Verified: Oct 1, 2001

• Keywords provided by , ,: AIDS-related primary CNS lymphoma
• Additional relevant MeSH terms: Lymphoma; Zidovudine; Methotrexate

Study Results

No Results Posted as of Sep 20, 2013