Rituximab and Liposomal Doxorubicin in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

NCT00244985 | Completed Phase 1 Results DMC

• 2 other identifiers: CDR0000447130RPC 02-04
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Complete Response Rate at 20 Weeks

  Complete Response (CR): During observation no disease is apparent, including measurable and non-measurable disease, for at least 28 days, as confirmed by a second assessment following the original observation of no disease. All nodes visualized on imaging studies or palpable on exams must have regressed to normal size their greatest transverse diameter for nodes \> 1.5 em before therapy). Previously involved nodes that were 1.1 to 1.5 in their greatest transverse diameter before treatment must have decreased to 1 cm in their greatest transverse diameter after treatment or by more than 75% in the sum of the products of the greatest diameters (SPD). The patient must also be free from symptoms related to lymphoma, if present before therapy with no worsening in performance status from baseline. Bone marrow, if initially positive at baseline, must be histologically negative for lymphoma and the liver and spleen, if enlarged due to lymphoma at baseline, should be normalized.

  20 weeks

Secondary Outcomes (4)

• Partial Response Rate at 20 Weeks

  20 weeks

• Overall Response Rate (Complete and Partial Responses) at 20 Weeks

  20 weeks

• Progression Free Survival (PFS) Rate at 2 Years

  2 years

• Overall Survival (OS) Rate at 2 Years

  2 years

Study Arms (1)

Arm 1: Rituximab and Doxorubicin HCI Liposome

EXPERIMENTAL

Patients receive rituximab IV over 3-8 hours on day 1 and doxorubicin HCl liposome IV over 1-3 hours on day 3

Biological: rituximab; Drug: pegylated liposomal doxorubicin hydrochloride

Interventions

rituximab BIOLOGICAL

IV

Arm 1: Rituximab and Doxorubicin HCI Liposome

pegylated liposomal doxorubicin hydrochloride DRUG

IV

Arm 1: Rituximab and Doxorubicin HCI Liposome

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• Ortho Biotech, Inc.: collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

MeSH Terms

Conditions

Lymphoma; Lymphoma, Follicular; Lymphoma, Mantle-Cell; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, Large B-Cell, Diffuse; Lymphoma, Non-Hodgkin; Lymphoma, B-Cell, Marginal Zone

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Hematologic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Myron S. Czuczman, MD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2005
• First Posted: October 27, 2005
• Study Start: September 1, 2005
• Primary Completion: August 1, 2008
• Study Completion: December 1, 2012
• Last Updated: August 17, 2017
• Results First Posted: July 14, 2017

Record last verified: 2017-07

Locations

US (1)