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A Phase I/II Pilot Study of the Safety and Efficacy of Rituxan (Chimeric Anti-CD20 Antibody) in Combination With Doxil (Liposomal Doxorubicin) Chemotherapy in Patients With Relapsing or Refractory Indolent or Aggressive B-Cell Lymphoma


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

A Phase I/II Pilot Study of the Safety and Efficacy of Rituxan (Chimeric Anti-CD20 Antibody) in Combination With Doxil (Liposomal Doxorubicin) Chemotherapy in Patients With Relapsing or Refractory Indolent or Aggressive B-Cell Lymphoma


OBJECTIVES:

Primary

- Determine the safety, including qualitative and quantitative toxic effects and their
duration and reversibility, of rituximab and doxorubicin HCl liposome in patients with
relapsed or refractory, indolent or aggressive CD20-positive B-cell non-Hodgkin's
lymphoma.

Secondary

- Determine the efficacy, including overall response rate and durability of objective
response, of this regimen in these patients.

- Correlate pretreatment functional, phenotypic, and genotypic characteristics of host
immune effector cells with response in patients treated with this regimen.

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

Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over
1-3 hours on day 3. Treatment repeats every 21 days for 6 courses in the absence of disease
progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 4 years.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of 1 of the following indolent or aggressive B-cell non-Hodgkin's lymphoma
(NHL) subtypes:

- Grade 1-3 follicular lymphoma

- Mantle cell lymphoma

- Small lymphocytic lymphoma

- Diffuse large B-cell lymphoma

- Diffuse mixed cell lymphoma

- Marginal zone lymphoma

- Relapsed or refractory CD20-positive disease

- Measurable disease

- Must have received ≥ 1 but < 4 prior standard chemotherapy regimens

- No Burkitt's lymphoma or precursor B-lymphoblastic lymphoma

- No CNS lymphoma

PATIENT CHARACTERISTICS:

Performance status

- Karnofsky 60-100%

Life expectancy

- At least 6 months

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 75,000/mm^3

- Hemoglobin > 7 g/dL

Hepatic

- AST or ALT < 2 times upper limit of normal (unless due to primary disease)

- Bilirubin ≤ 2 mg/dL

Renal

- Creatinine ≤ 2.0 mg/dL

Cardiovascular

- LVEF ≥ 50% by MUGA and/or 2-D echocardiogram

- No history of New York Heart Association class II-IV cardiac disease

- No congestive heart failure

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No known HIV positivity

- No uncontrolled active bacterial, viral, or fungal infection

- No other serious disease that would preclude study participation

- No other primary malignancy within the past 5 years except squamous cell or basal
cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Recovered from prior immunotherapy

- Prior immunotherapy, including rituximab or other monoclonal antibody, allowed

Chemotherapy

- See Disease Characteristics

- More than 4 weeks since prior chemotherapy and recovered

- No prior doxorubicin (or equivalent anthracycline) at a cumulative dose > 400 mg/m^2

- No other concurrent chemotherapy

Endocrine therapy

- Nonsteroidal hormones for nonlymphoma-related conditions (e.g., insulin for diabetes)
allowed

- No concurrent corticosteroids except for a transient inflammatory reaction (i.e.,
skin rash or hives)

Radiotherapy

- Recovered from prior radiotherapy

- No concurrent radiotherapy

Surgery

- More than 4 weeks since prior major surgery (other than diagnostic surgery) and
recovered

Other

- No other concurrent antitumor agents

- No other concurrent investigational agents

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response rate at 20 weeks

Outcome Time Frame:

20 weeks

Safety Issue:

No

Principal Investigator

Myron S. Czuczman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Roswell Park Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

CDR0000447130

NCT ID:

NCT00244985

Start Date:

September 2005

Completion Date:

Related Keywords:

  • Lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent mantle cell lymphoma
  • recurrent small lymphocytic lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263