Non Hodgkin Lymphoma Clinical Trial

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

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.

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

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Full 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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Study ID:

NCT00069966

Recruitment Status:

Unknown status

Sponsor:

Theradex

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There are 29 Locations for this study

See Locations Near You

Arizona Oncology Associates - Craycroft Road Offices
Tucson Arizona, 85712, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California, 90033, United States
Rocky Mountain Cancer Centers - Colorado Springs
Colorado Springs Colorado, 80933, United States
Rocky Mountain Cancer Centers - Denver Midtown
Denver Colorado, 80218, United States
Delaware Clinical & Laboratory Physicians
Newark Delaware, 19713, United States
Pasco, Hernando Oncology Associates, P.A.
New Port Richey Florida, 34652, United States
Hematology-Oncology Associates of Illinois
Chicago Illinois, 60611, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington Kentucky, 40536, United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport Louisiana, 71130, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
Boston Massachusetts, 02115, United States
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
North Shore University Hospital
Manhasset New York, 11030, United States
SUNY Upstate Medical University Hospital
Syracuse New York, 13210, United States
Duke Comprehensive Cancer Center
Durham North Carolina, 27710, United States
Piedmont Hematology-Oncology Associates
Winston-Salem North Carolina, 27103, United States
Gabrail Cancer Center - Canton Office
Canton Ohio, 44718, United States
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland Ohio, 44106, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
Cancer Care Associates-West
Oklahoma City Oklahoma, 73112, United States
Providence Cancer Center at Providence Portland Medical Center
Portland Oregon, 97213, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Cancer Centers of the Carolinas - Eastside
Greenville South Carolina, 29615, United States
Baylor University Medical Center
Dallas Texas, 75246, United States
University of Texas - MD Anderson Cancer Center
Houston Texas, 77030, United States
Fairfax Northern Virginia Hematology Oncology, P.C. - Fairfax
Fairfax Virginia, 22031, United States
Medical College of Wisconsin Cancer Center
Milwaukee Wisconsin, 53226, United States
Hospital Auxilio Mutuo
Hato Rey , 00918, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 2

Study ID:

NCT00069966

Recruitment Status:

Unknown status

Sponsor:


Theradex

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