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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


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

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Julie M. Vose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Nebraska

Authority:

United States: Federal Government

Study ID:

CDR0000316466

NCT ID:

NCT00069966

Start Date:

April 2003

Completion Date:

Related Keywords:

  • Lymphoma
  • 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
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
North Shore University HospitalManhasset, New York  11030
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Louisiana State University Health Sciences Center - ShreveportShreveport, Louisiana  71130-3932
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve UniversityCleveland, Ohio  44106
SUNY Upstate Medical University HospitalSyracuse, New York  13210
UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680
Baylor University Medical CenterDallas, Texas  75246
Providence Cancer Center at Providence Portland Medical CenterPortland, Oregon  97213-2967
Hematology-Oncology Associates of IllinoisChicago, Illinois  60611-2998
Cancer Centers of the Carolinas - EastsideGreenville, South Carolina  29601
Piedmont Hematology-Oncology AssociatesWinston-Salem, North Carolina  27103
Delaware Clinical & Laboratory PhysiciansNewark, Delaware  19713
Rocky Mountain Cancer Centers - Denver MidtownDenver, Colorado  80218
Gabrail Cancer Center - Canton OfficeCanton, Ohio  44718
Pasco, Hernando Oncology Associates, P.A.New Port Richey, Florida  
Arizona Oncology Associates - Craycroft Road OfficesTucson, Arizona  85712-2254
Rocky Mountain Cancer Centers - Colorado SpringsColorado Springs, Colorado  80933-1181
Cancer Care Associates-WestOklahoma City, Oklahoma  73112-4414
Fairfax Northern Virginia Hematology Oncology, P.C. - FairfaxFairfax, Virginia  22031