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Combination Chemotherapy (Methotrexate, Procarbazine And CCNU), Intraventricular Cytarabine And Methotrexate, +/- Intra-Ocular Chemotherapy For Patients With Primary Central Nervous System Lymphoma


Phase 2
16 Years
75 Years
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

Combination Chemotherapy (Methotrexate, Procarbazine And CCNU), Intraventricular Cytarabine And Methotrexate, +/- Intra-Ocular Chemotherapy For Patients With Primary Central Nervous System Lymphoma


OBJECTIVES:

Primary

- Determine the toxicity and efficacy of methotrexate, procarbazine, lomustine,
dexamethasone, and cytarabine in patients with primary CNS lymphoma.

Secondary

- Determine the ability to recruit adequate numbers of patients for this study.

- Compare progression-free and dementia-free survival with standard measures of overall
survival, progression-free survival, disease-free survival, complete response rate,
cognitive function, and quality of life of patients treated with this regimen.

- Determine the feasibility of conducting a future phase III study of this treatment
regimen in these patients.

- Correlate neuropsychological outcomes with neuroimaging (MRI) outcomes in patients
treated with this regimen.

OUTLINE: This is a nonrandomized, multicenter study.

- Induction chemotherapy: Patients receive methotrexate IV over 3 hours on days 1, 10,
and 20 and intraventricularly or intrathecally (IT) over 5 minutes on days 1, 5, 10,
and 15; oral procarbazine on days 1-7; oral lomustine on day 1; oral dexamethasone
every 6 hours on days 1-14 followed by a taper (as tolerated); and cytarabine
intraventricularly or IT over 5 minutes on days 1, 5, 10, and 15. Treatment repeats
every 42 days for a total of 3 courses. Patients with intraocular lymphoma also receive
methotrexate intravitreally twice weekly until the vitreous is clear of cells by slit
lamp exam. Patients with stable or responding disease proceed to maintenance therapy.

- Maintenance chemotherapy: Patients receive methotrexate IV over 3 hours and IT over 5
minutes on day 1; oral procarbazine on days 1-7; oral lomustine on day 1; oral
dexamethasone every 6 hours on days 1-14 followed by a taper (as tolerated); and
cytarabine intraventricularly or IT over 5 minutes on day 1. Treatment repeats every 42
days for a total of 5 courses.

Patients with intraocular lymphoma also receive methotrexate intravitreally weekly for 1
month and then monthly for 1 year.

Quality of life is assessed at baseline, at 6 months, at the completion of treatment, every
6 months for 2 years, and then annually thereafter.

Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then
annually thereafter.

PROJECTED ACCRUAL: A total of 180 patients will be accrued for this study within 3 years.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Edward A. Neuwelt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Federal Government

Study ID:

OHSU-5729-1

NCT ID:

NCT00074191

Start Date:

January 2000

Completion Date:

October 2000

Related Keywords:

  • Lymphoma
  • intraocular lymphoma
  • primary central nervous system lymphoma
  • Lymphoma

Name

Location

Oregon Health & Science University Cancer InstitutePortland, Oregon  97239-3098