Methotrexate, Procarbazine, Lomustine, Dexamethasone, and Cytarabine in Treating Patients With Primary CNS Lymphoma

NCT00074191 | Completed Phase 2 DMC

• 5 other identifiers: IRB000009295729-1ONC-99054-1929OHSU-5729-1
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as methotrexate, procarbazine, lomustine, dexamethasone, and cytarabine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have primary CNS lymphoma.

Conditions

Lymphoma

Keywords

intraocular lymphoma; primary central nervous system lymphoma

Outcome Measures

Primary Outcomes (1)

• Survival as measured by clinical and radiographic response at 5 years following completion of study treatment

  5 years

Secondary Outcomes (3)

• Overall survival as measured by clinical and radiographic response

  5 years

• Progression-free survival as measured by clinical and radiographic response until tumor progression

  5 years

• Quality of Life (QOL) as measured by EORTC QOL before and after study treatment, every 6 months for 2 years, and then annually

  5 years

Interventions

cytarabine DRUG

dexamethasone DRUG

lomustine DRUG

methotrexate DRUG

procarbazine hydrochloride DRUG

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed intermediate- or high-grade primary CNS lymphoma documented by brain biopsy or cerebrospinal fluid or vitrectomy analysis * Diagnosed within the past 90 days * No systemic lymphoma NOTE: A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: Age * 16 to 75 Performance status * ECOG 0-3 OR * Karnofsky 40-100% Life expectancy * Not specified Hematopoietic * WBC at least 2,500/mm\^3 * Hematocrit at least 25% (transfusion allowed) * Absolute granulocyte count at least 1,200/mm\^3 * Platelet count at least 100,000/mm\^3 OR at least lower limit of normal (transfusion independent) Hepatic * Bilirubin no greater than 2.0 times upper limit of normal Renal * Creatinine clearance at least 30 mL/min Cardiovascular * Adequate cardiac function to tolerate general anesthesia Pulmonary * Adequate pulmonary function to tolerate general anesthesia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception for 2 months before and during study participation * No other uncontrolled, clinically significant confounding medical condition within the past 30 days * No known allergy to study agents * HIV negative PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas) * Single-agent methotrexate administered within the past 14 days allowed Endocrine therapy * Not specified Radiotherapy * No prior cranial or spinal radiotherapy Surgery * Prior surgery or biopsy allowed

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

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Oregon Health & Science University Cancer Institute

Portland, Oregon, 97239-3098, United States

Location

MeSH Terms

Conditions

Lymphoma; Intraocular Lymphoma

Interventions

Cytarabine; Dexamethasone; Lomustine; Methotrexate; Procarbazine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Eye Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Nitrosourea Compounds; Urea; Amides; Organic Chemicals; Nitroso Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzamides; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Edward A. Neuwelt, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2003
• First Posted: December 11, 2003
• Study Start: January 1, 2000
• Primary Completion: October 1, 2000
• Study Completion: October 1, 2000
• Last Updated: April 21, 2017

Record last verified: 2017-04

Locations

US (1)