NCT00069966UnknownPhase 2
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
Theradex58 sites in 2 countriesStarted: April 1, 2003Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Locations
- 58
Study Overview
Brief 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.
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:
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •18 and over
- •Performance status
- •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
- •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
- •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
- •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
- +21 more not shown
Exclusion Criteria
- Not provided
Investigators
Study Sites (58)
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