Rituximab and Liposomal Doxorubicin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
This study is ongoing, but not recruiting participants.
Sponsor:
Roswell Park Cancer Institute
Collaborator:
Ortho Biotech, Inc.
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00244985
First received: October 25, 2005
Last updated: September 18, 2012
Last verified: September 2012
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Purpose
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as liposomal doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving rituximab together with liposomal doxorubicin may kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects of giving rituximab together with liposomal doxorubicin and to see how well they work in treating patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: rituximab Drug: pegylated liposomal doxorubicin hydrochloride |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Roswell Park Cancer Institute:
Primary Outcome Measures:
- Complete response rate at 20 weeks [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Partial response rate at 20 weeks [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- Overall response rate (complete and partial responses) at 20 weeks [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
- Time to disease progression at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Survival at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 42 |
| Study Start Date: | September 2005 |
| Estimated Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Biological: rituximab
IV
Drug: pegylated liposomal doxorubicin hydrochloride
IV
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244985
Locations
| United States, New York | |
| Roswell Park Cancer Institute | |
| Buffalo, New York, United States, 14263-0001 | |
Sponsors and Collaborators
Roswell Park Cancer Institute
Ortho Biotech, Inc.
Investigators
| Principal Investigator: | Myron S. Czuczman, MD | Roswell Park Cancer Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00244985 History of Changes |
| Other Study ID Numbers: | CDR0000447130, RPCI RPC02-04 |
| Study First Received: | October 25, 2005 |
| Last Updated: | September 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Roswell Park Cancer Institute:
|
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 |
Additional relevant MeSH terms:
|
Lymphoma Lymphoma, Non-Hodgkin Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Doxorubicin Rituximab Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 19, 2013