Methotrexate, Cyclophosphamide, and Etoposide Phosphate Given With Osmotic Blood-Brain Barrier Disruption Plus Dexamethasone and Cytarabine in Treating Patients With Primary CNS Lymphoma

NCT00074178 | Completed Phase 2 DMC

• 5 other identifiers: IRB000009355729-2ONC-99055-L935OHSU-5729-2
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as methotrexate, cyclophosphamide, etoposide phosphate, dexamethasone, and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Osmotic blood-brain barrier disruption uses certain drugs to open the blood vessels around the brain and allow anticancer substances to be delivered directly to the brain. Giving methotrexate, cyclophosphamide, and etoposide phosphate with osmotic blood-brain barrier disruption plus dexamethasone and cytarabine may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of giving methotrexate, cyclophosphamide, and etoposide phosphate with osmotic blood-brain barrier disruption plus dexamethasone and cytarabine in treating patients who have primary CNS lymphoma.

Conditions

Lymphoma

Keywords

primary central nervous system lymphoma; intraocular lymphoma

Outcome Measures

Primary Outcomes (1)

• Survival as measured by clinical and radiographic response at 5 years after study treatment

Secondary Outcomes (3)

• Overall survival as measured by clinical and radiographic response

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

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

Interventions

filgrastim BIOLOGICAL

pegfilgrastim BIOLOGICAL

cyclophosphamide DRUG

cytarabine DRUG

dexamethasone DRUG

etoposide phosphate DRUG

methotrexate 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 by brain biopsy or cerebrospinal fluid or vitrectomy analysis * No more than 90 days since diagnosis * 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 * Hematocrit at least 25% (transfusion allowed) * WBC at least 2,500/mm\^3 * 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

Filgrastim; pegfilgrastim; Cyclophosphamide; Cytarabine; Dexamethasone; etoposide phosphate; Methotrexate

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)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; 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; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Edward A. Neuwelt, MD

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• 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: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: April 21, 2017

Record last verified: 2017-04

Locations

US (1)