Radiation Therapy and High-Dose Corticosteroids in Treating Older Patients With Primary CNS Non-Hodgkin's Lymphoma

NCT00003278 | Completed Phase 2

• 2 other identifiers: NCCTG-967351CDR0000066184
• Study Type: interventional
• Target: 28
• Locations: 2 countries
• Sites: 14

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with a corticosteroid, such as dexamethasone, may be an effective treatment for non-Hodgkin's lymphoma. PURPOSE: Phase II trial to study the effectiveness of radiation therapy and high-dose dexamethasone in treating older patients with primary CNS non-Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

primary central nervous system non-Hodgkin lymphoma; intraocular lymphoma

Outcome Measures

Primary Outcomes (1)

• overall survival

  Up to 5 years

Study Arms (1)

radiation + dexamethasone

EXPERIMENTAL

Patients undergo whole-brain radiotherapy (WBRT) daily 5 days a week for 4.5 weeks. Beginning 30 days after WBRT is completed, patients receive high-dose dexamethasone IV on days 1-5 during course 1 and on day 1 only during all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month after radiotherapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Drug: dexamethasone; Radiation: radiation therapy

Interventions

dexamethasone DRUG

radiation + dexamethasone

radiation therapy RADIATION

radiation + dexamethasone

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

DISEASE CHARACTERISTICS: * Pathologically confirmed non-Hodgkin's lymphoma with intracranial lesions * Intraocular lymphoma eligible, if not sole site of disease * No occult systemic lymphoma * Measurable or evaluable disease by CT scan or MRI * No neoplastic meningitis or gross spinal cord involvement PATIENT CHARACTERISTICS: Age: * 70 and over Performance status: * ECOG 0-3 Other: * No prior history of lymphoma * No other active malignancy except basal cell skin cancer or carcinoma in situ of the cervix * HIV negative * No active peptic ulcer disease * No uncontrolled diabetes mellitus * No active pancreatitis * No active bleeding * No poorly controlled major psychiatric illness * No serious uncontrolled infection PRIOR CONCURRENT THERAPY: Biologic therapy: * No prior bone marrow transplantation Chemotherapy: * No prior chemotherapy Radiotherapy: * No prior radiotherapy to the brain or head and neck region Surgery: * No prior transplantations (renal, hepatic, or cardiac)

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

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Study Sites (14)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Location

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CentraCare Health Plaza

Saint Cloud, Minnesota, 56303, United States

Location

Medcenter One Health System

Bismarck, North Dakota, 58501, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Related Publications (3)

• O'Neill BP, Habermann TM, Witzig TE, Rodriguez M. Prevention of recurrence and prolonged survival in primary central nervous system lymphoma (PCNSL) patients treated with adjuvant high-dose methylprednisolone. Med Oncol. 1999 Sep;16(3):211-5. doi: 10.1007/BF02906134.

  PMID: 10523802 BACKGROUND

• Laack NN, Ballman KV, Brown PB, O'Neill BP; North Central Cancer Treatment Group. Whole-brain radiotherapy and high-dose methylprednisolone for elderly patients with primary central nervous system lymphoma: Results of North Central Cancer Treatment Group (NCCTG) 96-73-51. Int J Radiat Oncol Biol Phys. 2006 Aug 1;65(5):1429-39. doi: 10.1016/j.ijrobp.2006.03.061.

  PMID: 16863926 RESULT

• Laack NN, Ballman KV, Brown PD, et al.: Toxicity of whole-brain radiotherapy (WBRT) and high-dose methylprednisolone (HDMP) for elderly patients (70 years of age and older) with primary central nervous system lymphoma (PCNSL): results of North Central Cancer Treatment Group (NCCTG) 967351. [Abstract] Neuro-Oncology 6 (4): RT-11, 361, 2004.

  RESULT

MeSH Terms

Conditions

Lymphoma; Intraocular Lymphoma

Interventions

Dexamethasone; Radiotherapy

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)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Therapeutics

Study Officials

• Brian P. O'Neill, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: March 1, 1998
• Primary Completion: June 1, 2003
• Study Completion: June 1, 2003
• Last Updated: July 6, 2016

Record last verified: 2016-07

Locations

US (13); CA (1)