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A Phase I Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin in the Treatment of Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma


Phase 1
18 Years
64 Years
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

A Phase I Trial of BBR 2778 in Combination With Cytarabine, Methylprednisolone and Cisplatin in the Treatment of Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma


OBJECTIVES:

- Determine the maximum tolerated dose and recommended dose of pixantrone when
administered with cytarabine, methylprednisolone, and cisplatin in patients with
relapsed or refractory aggressive non-Hodgkin's lymphoma.

- Determine the dose-limiting toxic effects of this regimen in these patients.

- Determine the relationship between toxicity and systemic exposure to this regimen in
these patients.

- Determine the safety of this regimen in these patients.

- Assess the pharmacokinetics of this regimen in these patients.

- Determine, preliminarily, the efficacy of this regimen in these patients.

OUTLINE: This is an open-label, non-randomized, multicenter, dose-escalation study of
pixantrone.

Patients receive pixantrone IV over 1 hour on day 1, methylprednisolone IV over 15 minutes
on days 1-5, cisplatin IV over 30 minutes on days 1-4, and cytarabine IV over 2 hours on day
5. Treatment repeats every 21 days for at least 8 courses in the absence of disease
progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of pixantrone until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose at which no more than 2 of 6
patients experience dose-limiting toxicity. Additional patients are treated at the
recommended dose, which is defined as the dose preceding the MTD.

Patients are followed every 3 months.

PROJECTED ACCRUAL: Approximately 3-30 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed relapsed or refractory aggressive non-Hodgkin's lymphoma
(NHL) including the following:

- Diffuse large B-cell lymphoma

- Transformed NHL

- Follicular large cell lymphoma

- Peripheral T-cell lymphoma

- Unclassified aggressive histology (immunoblastic lymphoma)

- Must have received 1 to 3 prior chemotherapy treatment regimens (may include
doxorubicin up to a cumulative dose of no greater than 450 mg/m^2)

- No Burkitt's lymphoma, lymphoblastic lymphoma, or mantle cell lymphoma

PATIENT CHARACTERISTICS:

Age

- 18 to 64

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 evidence
of bone marrow involvement

Hepatic

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)**

- Alkaline phosphatase no greater than 2 times ULN**

- AST or ALT no greater than 2 times ULN**

- No history or clinical symptoms of hepatitis B or C virus NOTE: **Higher values may
be accepted if evidence of liver involvement

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 class II-IV heart disease

- No myocardial infarction within the past 6 months

- No severe arrhythmia

- No uncontrolled hypertension

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 6 months
after study

- No history or clinical symptoms of HIV

- No clinically significant neurological abnormalities

- No serious uncontrolled infection (NCI CTC grade 3-4)

- No condition that would place the patient at undue risk or interfere with the study
results

PRIOR CONCURRENT THERAPY:

Biologic therapy

- At least 3 months since prior radioimmunotherapy

Chemotherapy

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy

- At least 1 year since prior platinum or cytarabine (unless complete response to
treatment)

- At least 2 years since prior fludarabine or nitrosoureas

- No prior cumulative cisplatin greater than 600 mg/m^2

Endocrine therapy

- Not specified

Radiotherapy

- See Biologic therapy

- At least 4 weeks since prior radiotherapy

- No prior radiotherapy to the whole pelvis

Surgery

- At least 1 week since prior minor surgery and recovered

- At least 4 weeks since prior major thoracic and/or abdominal surgery and recovered

Other

- At least 1 month since prior investigational drugs

- Recovered from prior therapy

- No other concurrent investigational drugs

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Luis Fayad, MD

Investigator Role:

Study Chair

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000269140

NCT ID:

NCT00053105

Start Date:

February 2002

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
Ireland Cancer CenterCleveland, Ohio  44106-5065
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Marlene and Stewart Greenebaum Cancer Center, University of MarylandBaltimore, Maryland  21201-1595
Arizona Clinical Research CenterTucson, Arizona  85712
Highlands Oncology GroupSpringdale, Arkansas  72764
Boston Baskin Cancer Group, University TennesseeMemphis, Tennessee  38104