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LymphomaPhase 2NCT00006695

Monoclonal Antibody Therapy, Combination Chemotherapy, and Peripheral Stem Cell Transplant in Non-Hodgkin's Lymphoma

A Phase 2 study testing carmustine, cytarabine and etoposide in people with Lymphoma, run by University of Nebraska at 1 site 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: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Read more about this study

Who is it for?
Ages 19 to 70 years
Conditions the study is for
Lymphoma
What is being tested?
carmustine, cytarabine and etoposide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
1 Apr 2000to 16 Dec 2014
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 19 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of non-Hodgkin's lymphoma (NHL) of one of the following types:
  • Diffuse large B-cell
  • Composite (at least 50% of tumor showing diffuse histology)
  • Diffuse mixed cell
  • Immunoblastic
  • Relapsed or refractory disease sensitive to initial or subsequent conventional therapy (at least a partial response)
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  • Eligible for high-dose carmustine, etoposide, cytarabine, and melphalan protocol and autologous bone marrow transplantation or peripheral blood stem cell transplantation
  • Evidence of CD20 antigen expression in tumor tissue
  • Bidimensionally measurable disease
  • Adequate peripheral blood stem cells
  • At least 15,000,000 CD34+ cells/kg or
  • At least 25,000 granulocyte macrophage colony-forming units/kg
  • Age: 19 to 70
  • Performance status: Karnofsky 70-100%
  • Life expectancy: at least 4 months post-transplantation
  • Bilirubin less than 2.0 mg/dL
  • Creatinine less than 2.0 mg/dL
  • Cardiac ejection fraction at least 40% for any of the following criteria:
  • Age 60 and over
  • Significant cardiac history (myocardial infarction or congestive heart failure)
  • Received greater than 350 mg/m^2 of prior doxorubicin
  • DLCO at least 50% of predicted
  • HIV negative
  • Fertile patients must use effective contraception during and for at least 6 months after study participation
  • At least 4 weeks since prior biologic therapy and recovered
  • Human antimouse antibody negative
  • At least 4 weeks since prior cytotoxic chemotherapy and recovered
  • At least 4 weeks since prior radiotherapy and recovered
  • At least 4 weeks since prior immunosuppressants and recovered

Who cannot join

  • No progressive disease in a field that has been previously irradiated with more than 3,500 cGy within the past year
  • No known brain or leptomeningeal metastases
  • No active obstructive hydronephrosis
  • No New York Heart Association class III or IV heart disease
  • No evidence of severe organ dysfunction
  • No other major medical illnesses
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  • No active infection requiring IV antibiotics
  • No other malignancy within the past 5 years except adequately treated skin cancer or carcinoma in situ of the cervix
  • Not pregnant/negative pregnancy test
  • No prior peripheral blood stem cell transplantation following high-dose chemotherapy or chemoradiotherapy
  • No other concurrent biologic therapy for NHL
  • No concurrent steroids except maintenance-dose steroids for noncancerous disease
  • No concurrent external beam radiotherapy for NHL
  • No other concurrent participation on protocol involving non-FDA-approved drugs or biologics

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UNMC Eppley Cancer Center at University of Nebraska Medical Center

    Omaha, Nebraska, 68198-6805

Other trials in United States

About this study

Official title: BEAM Plus Iodine-131 Anti-B1 Antibody and Autologous Hematopoietic Stem Cell Transplantation for Treatment of Recurrent Diffuse Large B-Cell Non-Hodgkin's Lymphoma

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.

PURPOSE: This phase II trial is studying how well monoclonal antibody therapy, chemotherapy, and peripheral stem cell transplant work in treating patients with relapsed or refractory non-Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

  • Compare the response rates and time to treatment failure in patients with relapsed or refractory non-Hodgkin's lymphoma treated with iodine I 131 monoclonal antibody anti-B1, followed by high-dose carmustine, etoposide, cytarabine, and melphalan (BEAM), and autologous peripheral blood stem cell transplantation (APBSCT) vs historical control patients treated with high-dose BEAM or carmustine, etoposide, cytarabine, and cyclophosphamide and APBSCT.
  • Determine the safety of this regimen in these patients.

OUTLINE: Autologous peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells or granulocyte macrophage colony-forming units. On day -19, patients receive unlabeled monoclonal antibody anti-B1 (MOAB anti-B1) IV followed by a dosimetric dose of iodine I 131 MOAB anti-B1 IV over 20 minutes. On day -12, patients receive unlabeled MOAB anti-B1 IV followed by a therapeutic dose of iodine I 131 MOAB anti-B1 IV over 20 minutes. Patients then receive high-dose chemotherapy comprising carmustine IV on day -6, etoposide IV and cytarabine IV twice daily on days -5 to -2, and melphalan IV on day -1. Patients undergo autologous PBSC transplantation on day 0.

Patients are followed at days 30 and 100, at 6 months, and then annually thereafter.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study over 5 years.

Conditions
Lymphoma
Keywords
recurrent adult diffuse mixed cell lymphoma, recurrent adult diffuse large cell lymphoma, recurrent adult immunoblastic large cell lymphoma
Medical subject headings
Lymphoma, Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Immunoblastic

What participants receive

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

  • carmustineDrug

    Also called BCNU

    300 mg/m2 IV on Day -6

  • cytarabineDrug

    Also called cytosine arabinoside

    100 mg/m2 BID on Days -5 through -2

  • etoposideDrug

    Also called Etopophos, Toposar

    100 mg/m2 BID on Days -5 through -2

  • melphalanDrug

    Also called Evomela

    140 mg/m2 IV on Day -1

  • peripheral blood stem cell transplantationProcedure or surgery

    Also called Autologous Hematopoietic Stem Cell Transplantation

    Following the chemotherapy, on Day 0 of treatment, the previously stored hematopoietic stem cells will be administered to the patient intravenously through a central line to the patient.

  • tositumomab and iodine I 131 tositumomabRadiation

    Also called Iodine-131 Anti-B1 Antibody

    Patients will receive two administrations of Iodine-131 Anti-B1 Antibody; the "dosimetric dose" and the "therapeutic dose". The dosimetric dose will consist of an infusion of unlabeled Anti-B1 Antibody (450 mg) immediately followed by an infusion of Anti-B1 Antibody (35 mg) which has been trace labeled with 5 mCi of Iodine-131 Anti-B1 Antibody. Using whole body anterior and posterior gamma camera scans and serial imaging studies over approximately one week, the clearance of the whole body dosimetric dose will be used to calculate the subsequent therapeutic dose of Iodine-131 Anti-B1 Antibody which delivers a total body dose of 75 cGy to the subject

Study groups in NCT00006695
Study groupRoleWhat they receive
Arm IExperimentalIodine-131 Anti-B1 Antibody/BEAM/autologous hematopoietic stem cell transplantation (AHSCT)
Receives: Drug: carmustine; Drug: cytarabine; Drug: etoposide; Drug: melphalan; Procedure: peripheral blood stem cell transplantation; Radiation: tositumomab and iodine I 131 tositumomab

What is being measured

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

  1. Event free survival rate

    Participant survival without adverse events or progression

    Measured: 100 days post transplant and at yearly intervals

Secondary outcomes (2)

  1. Time to treatment failure

    Time from registration to time of treatment discontinuation or withdrawal for progression

    Measured: time of registration to time of treatment discontinuation or withdrawal for progression

  2. Overall survival

    Time from first participant enrollment to last participant death or end of study

    Measured: Time from registration to last participant death

Timeline

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

  1. First posted27 Jan 2003 (estimated)
  2. Study start1 Apr 2000
  3. Primary completion1 Sep 2005
  4. Study completion16 Dec 2014

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
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006695
Sponsor's protocol ID
0051-00-FB
Other IDs
COULTER-IND-3323
Status last verified
Aug 2023
First submitted
6 Dec 2000
Last updated
1 Sep 2023
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing carmustine, cytarabine and etoposide in people with Lymphoma, run by University of Nebraska at 1 site 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?

The sponsor lists 29 inclusion and 14 exclusion criteria. 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 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Event free survival rate (time frame: 100 days post transplant and at yearly intervals). 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 NCT00006695.

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 1 Sep 2023.

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