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LymphomaPhase 2NCT00002676

Chemotherapy and Whole-Brain Radiation Therapy in Treating Patients With Primary Central Nervous System Non- Hodgkin's Lymphoma

A Phase 2 study testing carmustine, cyclophosphamide and cytarabine in people with Lymphoma, run by Alliance for Clinical Trials in Oncology at 21 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells and may be an effective treatment for non-Hodgkin's lymphoma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lymphoma
What is being tested?
carmustine, cyclophosphamide and cytarabine
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
21 sitesUnited States
Study dates
Jul 1995to Oct 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS: Primary central nervous system non-Hodgkin's lymphoma (PCNSL) Clinically diagnosed intracranial space-occupying lesion Pathology consistent with non-Hodgkin's lymphoma and reviewed by NCCTG Biopsy optional if characteristic history, pathognomonic neuroimaging, and cytology are consistent with malignant lymphocytes from vitrectomy, CSF, or both No occult systemic lymphoma or prior lymphoma No post-transplant lymphoproliferative disorder Disease measurable or evaluable on postoperative contrast-enhanced CT or MRI Postoperative therapy must start within 6 weeks of definitive diagnosis

PATIENT CHARACTERISTICS: Age: 18 to 70 Performance status: ECOG 0-3 Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 120,000/mm3 Hepatic: Bilirubin no greater than 2 times normal AST no greater than 2 times normal Renal: Creatinine no greater than 1.5 times normal Cardiovascular: No heart failure No uncontrolled arrhythmia Pulmonary: No severe pulmonary failure Other: No serious uncontrolled infection No active bleeding No AIDS or HIV-positive serology No prior organ transplant No pregnant or nursing women Negative pregnancy test required of fertile women Adequate contraception required of fertile patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Corticosteroids allowed if dose fixed or decreasing for at least 1 week prior to baseline scan Radiotherapy: No prior radiotherapy Surgery: Not specified

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

United States21 sites

  • Quain & Ramstad Clinic, P.C.

    Bismarck, North Dakota, 58501

  • CCOP - Cedar Rapids Oncology Project

    Cedar Rapids, Iowa, 52403-1206

  • CCOP - Columbus

    Columbus, Ohio, 43206

  • CCOP - Colorado Cancer Research Program, Inc.

    Denver, Colorado, 80209-5031

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa, 50309-1016

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Altru Health Systems

    Grand Forks, North Dakota, 58201

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • CCOP - Kalamazoo

    Kalamazoo, Michigan, 49007-3731

  • CCOP - Ochsner

    New Orleans, Louisiana, 70121

  • CCOP - Missouri Valley Cancer Consortium

    Omaha, Nebraska, 68131

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois, 61602

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57709

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • CCOP - Scottsdale Oncology Program

    Scottsdale, Arizona, 85259-5404

  • Siouxland Hematology-Oncology

    Sioux City, Iowa, 51101-1733

  • CCOP - Sioux Community Cancer Consortium

    Sioux Falls, South Dakota, 57105-1080

  • CCOP - Toledo Community Hospital Oncology Program

    Toledo, Ohio, 43623-3456

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • CCOP - Wichita

    Wichita, Kansas, 67214-3882

Other trials in United States

About this study

Official title: PHASE II TRIAL OF CHEMOTHERAPY PLUS RADIOTHERAPY FOR MANAGEMENT OF PRIMARY CENTRAL NERVOUS SYSTEM NON-HODGKIN'S LYMPHOMA (PCNSL)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells and may be an effective treatment for non-Hodgkin's lymphoma.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and whole-brain radiation therapy in patients with primary central nervous system non-Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES: I. Assess the response to CHOD (cyclophosphamide/doxorubicin/vincristine/ dexamethasone) and BVAM (carmustine/vincristine/cytarabine/methotrexate) plus whole-brain radiotherapy in patients with primary central nervous system non-Hodgkin's lymphoma (PCNSL). II. Assess the toxic effects associated with this treatment. III. Assess the survival of patients with PCNSL receiving this treatment. IV. Investigate the frequency of systemic involvement at follow-up. V. Identify factors that appear to be associated with outcome.

Conditions
Lymphoma
Keywords
primary central nervous system non-Hodgkin lymphoma
Medical subject headings
Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00002676
Study groupRoleWhat they receive
CHOD + BVAM + WBRTExperimentalPatients 70 years old and younger with newly diagnosed, biopsy-proven PCNSL received one cycle of CHOD followed by two cycles of BVAM. Patients then received WBRT, 30.6 Gy, if a complete response was evoked, or 50.4 Gy if the response was less than complete; both doses were given in 1.8-Gy daily fractions.
Receives: Drug: carmustine; Drug: cyclophosphamide; Drug: cytarabine; Drug: dexamethasone; Drug: doxorubicin hydrochloride; Drug: methotrexate; Drug: vincristine sulfate; Radiation: low-LET cobalt-60 gamma ray therapy; Radiation: low-LET photon therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response rate

    Measured: Up to 10 years

Secondary outcomes (1)

  1. Overall survival

    Measured: Up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2004 (estimated)
  2. Study startJul 1995
  3. Primary completionOct 2006
  4. Study completionOct 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002676
Sponsor's protocol ID
NCCTG-937351
Other IDs
E-N9371, CDR0000064319
Status last verified
Jul 2016
First submitted
1 Nov 1999
Last updated
14 Jul 2016
Results posted
No
Data monitoring committee
No

Publications

  • Laack NN, O'Neill BP, Ballman KV, O'Fallon JR, Carrero XW, Kurtin PJ, Scheithauer BW, Brown PD, Habermann TM, Colgan JP, Gilbert MR, Hawkins RB, Morton RF, Windschitl HE, Fitch TR, Pajon ER Jr; North Central Cancer Treatment Group and Mayo Clinic. CHOD/BVAM chemotherapy and whole-brain radiotherapy for newly diagnosed primary central nervous system lymphoma. Int J Radiat Oncol Biol Phys. 2011 Oct 1;81(2):476-82. doi: 10.1016/j.ijrobp.2010.06.002. Epub 2010 Aug 26.

    PubMed 20800387

  • O'Neill BP, O'Fallon JR, Cha SS, et al.: Newly diagnosed primary central nervous system lymphoma (PCNSL): initial report of North Central Cancer Treatment Group (NCCTG)/Eastern Cooperative Oncology Group (ECOG) protocol 93 73 51. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-2074, 2002.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carmustine, cyclophosphamide and cytarabine in people with Lymphoma, run by Alliance for Clinical Trials in Oncology at 21 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002676, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2016.

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