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LymphomaPhase 2NCT00069966

Pixantrone, Cytarabine, Methylprednisolone, and Cisplatin in Treating Patients With Aggressive Non-Hodgkin's Lymphoma in First Relapse

A Phase 2 study testing filgrastim, rituximab and cisplatin in people with Lymphoma, run by Theradex at 29 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Drugs used in chemotherapy, such as pixantrone, cytarabine, methylprednisolone, and cisplatin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma
What is being tested?
filgrastim, rituximab and cisplatin
Type of treatment
Surgery or procedure
How many people
Not given
Where
29 sitesin 2 countries
Study dates
Apr 2003to not given
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed aggressive non-Hodgkin's lymphoma (NHL)
  • Any stage, with or without B symptoms
  • The following subtypes are eligible:
  • Diffuse large cell (B and T cell types)
  • Anaplastic large cell
  • Diffuse mixed cell
  • Immunoblastic large cell
  • Follicular large cell
  • Transformed follicular NHL
  • Diffuse aggressive not otherwise classified
  • Burkitt-like lymphoma
  • Bone marrow positive or negative
  • At least 1 measurable lesion
  • Patients with bone marrow as the only site of disease are eligible without a measurable lesion
  • No more than 1 episode of progressive disease, occurring after a response (complete response [CR], complete response unconfirmed [CR_u], or partial response [PR]) to prior chemotherapy* NOTE: *Patients with less than a CR, CRu, or PR and no progression, but who are good candidates for high-dose chemotherapy with stem cell support may be eligible (will be decided on an individual basis)
  • No chemotherapy-refractory disease, defined as follows:
  • Stable or progressive disease documented at restaging immediately after the completion of induction therapy
  • No lymphoblastic lymphoma, or mantle cell lymphoma

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-1

Life expectancy

  • At least 3 months

Hematopoietic

  • Neutrophil count at least 1,500/mm^3*
  • Platelet count at least 100,000/mm^3* NOTE: *Lower values may be accepted if clearly due to bone marrow involvement by lymphoma

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)*
  • AST or ALT no greater than 2.0 times ULN*
  • Alkaline phosphatase no greater than 2.0 times ULN*
  • No history or clinical symptoms of hepatitis B or hepatitis C virus
  • Patients with seropositivity due to prior vaccination for hepatitis B are eligible NOTE: *Higher values may be accepted if clearly due to liver involvement by lymphoma

Renal

  • Creatinine no greater than 1.5 mg/dL

Cardiovascular

  • LVEF at least 50% by MUGA
  • No clinically significant cardiovascular abnormalities
  • No New York Heart Association grade II-IV cardiovascular disease
  • No myocardial infarction within the past 6 months
  • No severe cardiac arrhythmia
  • No uncontrolled hypertension

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 months after study participation
  • HIV negative
  • No clinically significant neurological abnormalities
  • No condition that would preclude study safety or interfere with study results
  • No concurrent serious uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior rituximab immediately after the first chemotherapy regimen allowed

Chemotherapy

  • See Disease Characteristics
  • See Biologic therapy
  • At least 6 months since prior anthracycline therapy (e.g., cyclophosphamide, doxorubicin, vincristine, and prednisone [CHOP])
  • More than 2 years since prior fludarabine
  • More than 2 years since prior nitrosoureas
  • More than 1 year since prior platinum-based chemotherapy or cytarabine, unless a CR or CR_u was achieved
  • No prior cumulative dose of cisplatin greater than 600 mg/m^2
  • No prior single or cumulative dose of doxorubicin greater than 450 mg/m^2

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior radiotherapy to the whole pelvis
  • No prior radioimmunotherapy

Surgery

  • More than 4 weeks since prior major thoracic and/or abdominal surgery
  • At least 1 week since prior minor surgery

Other

  • Recovered from prior therapy
  • Alopecia allowed
  • Grade 1 peripheral neuropathy allowed
  • More than 30 days since prior participation in another investigational drug study
  • No other concurrent investigational drugs

Trial locations and contacts

29 sites in 2 countries.

29 sites in 2 countries

United States28 sites
  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

  • Gabrail Cancer Center - Canton Office

    Canton, Ohio, 44718

  • Hematology-Oncology Associates of Illinois

    Chicago, Illinois, 60611-2998

  • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

    Cleveland, Ohio, 44106-5055

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Rocky Mountain Cancer Centers - Colorado Springs

    Colorado Springs, Colorado, 80933-1181

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Centers - Denver Midtown

    Denver, Colorado, 80218

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010-3000

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

  • Fairfax Northern Virginia Hematology Oncology, P.C. - Fairfax

    Fairfax, Virginia, 22031

  • Cancer Centers of the Carolinas - Eastside

    Greenville, South Carolina, 29615

  • Penn State Cancer Institute at Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • University of Texas - MD Anderson Cancer Center

    Houston, Texas, 77030

  • Markey Cancer Center at University of Kentucky Chandler Medical Center

    Lexington, Kentucky, 40536-0084

  • USC/Norris Comprehensive Cancer Center and Hospital

    Los Angeles, California, 90033-0804

  • North Shore University Hospital

    Manhasset, New York, 11030

  • Medical College of Wisconsin Cancer Center

    Milwaukee, Wisconsin, 53226-3596

  • Pasco, Hernando Oncology Associates, P.A.

    New Port Richey, Florida, 34652

  • Delaware Clinical & Laboratory Physicians

    Newark, Delaware, 19713

  • Cancer Care Associates-West

    Oklahoma City, Oklahoma, 73112-4414

  • UNMC Eppley Cancer Center at the University of Nebraska Medical Center

    Omaha, Nebraska, 68198-7680

  • Providence Cancer Center at Providence Portland Medical Center

    Portland, Oregon, 97213

  • Louisiana State University Health Sciences Center - Shreveport

    Shreveport, Louisiana, 71130-3932

  • SUNY Upstate Medical University Hospital

    Syracuse, New York, 13210

  • Arizona Oncology Associates - Craycroft Road Offices

    Tucson, Arizona, 85712-2254

  • Piedmont Hematology-Oncology Associates

    Winston-Salem, North Carolina, 27103

Other trials in United States

Puerto Rico1 site
  • Hospital Auxilio Mutuo

    Hato Rey, 00918

Other trials in Puerto Rico

About this study

Official title: A Phase II Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin (BSHAP) as Salvage in Patients With Relapsed Aggressive Non-Hodgkin's Lymphoma

RATIONALE: Drugs used in chemotherapy, such as pixantrone, cytarabine, methylprednisolone, and cisplatin, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have relapsed aggressive non-Hodgkin's lymphoma.

Read the detailed description

OBJECTIVES:

  • Determine the antitumor activity of pixantrone, cytarabine, methylprednisolone, and cisplatin in patients with aggressive non-Hodgkin's lymphoma in first relapse.
  • Determine the safety and tolerability of this regimen in these patients.
  • Determine the validity and safety of this regimen as a mobilization regimen before high-dose chemotherapy with stem cell support in these patients.

OUTLINE: This is an open-label, multicenter study.

  • Salvage therapy: Patients receive pixantrone IV over 1 hour on day 1; cisplatin IV over 30 minutes on days 1-4; methylprednisolone IV over 15-30 minutes on days 1-5; and cytarabine IV over 2 hours on day 5. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

After 2 courses of salvage therapy, patients are re-evaluated and treated as follows:

  • Complete response (CR) or partial response (PR): Patients with a CR or PR who are suitable candidates for autologous stem cell transplantation (ASCT) proceed to mobilization therapy, high-dose chemotherapy, and ASCT. Patients with a CR or PR who are unsuitable candidates for ASCT continue to receive salvage therapy for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Stable disease: Patients with stable disease continue to receive salvage therapy for up to 6 courses. Patients who have a CR or PR after 3-4 courses of salvage therapy and who are suitable candidates for ASCT proceed to mobilization therapy, high-dose chemotherapy, and ASCT off study at the investigator's discretion.
  • Mobilization therapy (optional regimen; regimen used for mobilization is at the investigator's discretion): Patients receive rituximab* IV on days 1 and 7; pixantrone IV over 1 hour on day 2; cisplatin IV over 30 minutes on days 2-5; cytarabine IV over 2 hours on day 6; and methylprednisolone IV over 15-30 minutes on days 2-6. Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 7 and continuing until blood counts recover. Patients receive 1 or more courses of mobilization therapy during which stem cells are harvested. Patients then proceed to high-dose chemotherapy and subsequent re-infusion of harvested stem cells.

NOTE: *If this mobilization regimen is used, patients with T-cell lymphoma do not receive rituximab

  • High-dose chemotherapy and ASCT: Patients receive high-dose chemotherapy and ASCT per institutional standard practice.

Patients are followed every 3 months for 2 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.

Conditions
Lymphoma
Keywords
recurrent adult diffuse large cell lymphoma, anaplastic large cell lymphoma, recurrent adult diffuse mixed cell lymphoma, recurrent adult immunoblastic large cell lymphoma, recurrent grade 3 follicular lymphoma, recurrent adult Burkitt lymphoma
Medical subject headings
Lymphoma, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Lymphoma, Large-Cell, Immunoblastic, Lymphoma, Follicular, Burkitt Lymphoma

What participants receive

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

Timeline

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

  1. First posted7 Oct 2003 (estimated)
  2. Study startApr 2003

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
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00069966
Sponsor's protocol ID
CDR0000316466
Other IDs
THERADEX-AZA-II-02, CWRU-NOVU-1403, SUNY-HSC-4849, NOVUSPHARMA-AZA-II-02
Status last verified
Nov 2004
First submitted
3 Oct 2003
Last updated
7 Jul 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing filgrastim, rituximab and cisplatin in people with Lymphoma, run by Theradex at 29 sites in 2 countries.

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: status not confirmed, as of the sponsor's last update on 7 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Puerto Rico. 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?

Results are not available in the source record.

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.

Where can I read the original study information?
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 7 Jul 2009.

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