Know Cancer

or
forgot password

A Pilot Study of Combined Immunochemotherapy Followed by Reduced Dose RT for Patients With Newly Diagnosed PCNSL


Phase 2
N/A
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

A Pilot Study of Combined Immunochemotherapy Followed by Reduced Dose RT for Patients With Newly Diagnosed PCNSL


OBJECTIVES:

- Determine the efficacy of induction immunochemotherapy comprising rituximab,
methotrexate, procarbazine, and vincristine followed by reduced-dose radiotherapy and
consolidation cytarabine in patients with newly diagnosed primary central nervous
system lymphoma.

- Determine the 2-year and overall disease-free survival of patients treated with this
regimen.

- Determine the progression-free and overall survival of patients treated with this
regimen.

- Determine the acute treatment-related toxicity and safety of this regimen in these
patients.

- Determine the initial response rate of patients treated with immunochemotherapy.

- Determine the relapse rate after complete response in patients treated with this
regimen.

- Determine the neuro-cognitive outcome in patients treated with this regimen.

OUTLINE: This is a multicenter, pilot study.

- Induction immunochemotherapy: Patients receive rituximab IV over 5 hours on day 1 and
methotrexate IV over 2 hours and vincristine IV over several minutes on day 2. Patients
also receive oral procarbazine on days 2-8 during courses 1, 3, and 5. Treatment
repeats every 2 weeks for 5 courses in the absence of disease progression or
unacceptable toxicity. Patients with a partial response after 5 courses may receive an
additional 2 courses.

- Radiotherapy: Beginning 3-5 weeks after completion of induction immunochemotherapy,
patients undergo radiotherapy daily 5 days a week for 3-6 weeks.

- Consolidation chemotherapy: Patients receive cytarabine IV over 3 hours on days 1 and
2. Treatment repeats every 28 days for a total of 2 courses.

Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months
for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 3 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed primary non-Hodgkin's lymphoma by brain biopsy

- Patients who have an inconclusive biopsy or who are not a candidate for biopsy
are eligible provided they have a typical cranial MRI or CT scan* AND meet at
least 1 of the following criteria:

- Positive cerebrospinal fluid cytology for lymphoma or a monoclonal
lymphocyte population as defined by cell surface markers

- Biopsy of the vitreous or uvea demonstrating non-Hodgkin's lymphoma NOTE:
*Typical MRI or CT scan is defined as the presence of hypo-, iso-, or
hyperdense parenchymal contrast-enhancing (usually homogeneously) mass
lesion(s)

- HIV-1 negative

- Normal or negative pretreatment systemic evaluation including the following
examinations:

- Bone marrow aspirate and biopsy

- CT scans of the chest, abdomen, and pelvis

PATIENT CHARACTERISTICS:

Age

- Any age

Performance status

- Not specified

Life expectancy

- At least 8 weeks

Hematopoietic

- WBC at least 4,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 2.0 mg/dL

- SGOT no greater than 2 times upper limit of normal

Renal

- Creatinine no greater than 1.5 mg/dL OR

- Creatinine clearance at least 50 mL/min

Other

- Not pregnant

- Fertile patients must use effective contraception during and for 6 months after study
participation

- No other active primary malignancy except basal cell skin cancer or carcinoma in situ
of the cervix

- No pre-existing immunodeficiency (e.g., renal transplantation recipient)

- Must maintain a tyramine-free diet (i.e., free of alcohol and certain cheeses) during
procarbazine administration

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior chemotherapy for CNS lymphoma

Endocrine therapy

- Not specified

Radiotherapy

- No prior cranial radiotherapy

Surgery

- Not specified

Other

- No citrus fruit, citrus fruit juices, or ascorbic acid supplements during and for 72
hours after methotrexate administration

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Outcome Measure:

Treatment related toxicity assessed by NCI CTC

Safety Issue:

Yes

Principal Investigator

Lauren E. Abrey, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000298992

NCT ID:

NCT00059956

Start Date:

August 2002

Completion Date:

Related Keywords:

  • Lymphoma
  • primary central nervous system non-Hodgkin lymphoma
  • Lymphoma

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
Vermont Cancer Center at University of VermontBurlington, Vermont  05405-0075
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Kentuckiana Cancer Institute, PLLCLouisville, Kentucky  40202