Rituximab, Gemcitabine, and Vinorelbine in Treating Patients With Hodgkin Lymphoma That Has Relapsed or Not Responded to Treatment
This study has been withdrawn prior to enrollment.
Sponsor:
University of Miami Sylvester Comprehensive Cancer Center
Information provided by (Responsible Party):
University of Miami Sylvester Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00881387
First received: April 14, 2009
Last updated: February 18, 2013
Last verified: February 2013
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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 cell-killing substances to them. Drugs used in chemotherapy, such as gemcitabine and vinorelbine, 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 gemcitabine and vinorelbine may kill more cancer cells.
PURPOSE: This phase II trial is studying how well giving rituximab together with gemcitabine and vinorelbine works in treating patients with Hodgkin lymphoma that has relapsed or not responded to treatment.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Biological: rituximab Drug: gemcitabine hydrochloride Drug: vinorelbine ditartrate |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Pilot Study of Rituximab-Gemcitabine-Navelbine for Relapsed/Refractory Hodgkin's Lymphoma |
Resource links provided by NLM:
Drug Information available for:
Vinorelbine
Gemcitabine
Gemcitabine hydrochloride
Vinorelbine tartrate
Rituximab
U.S. FDA Resources
Further study details as provided by University of Miami Sylvester Comprehensive Cancer Center:
Primary Outcome Measures:
- Response rate (complete response, unconfirmed complete response, partial response) [ Time Frame: After first 3 cycles of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free survival, failure-free survival, and overall survival [ Time Frame: Treatment start date to date of death for any reason ] [ Designated as safety issue: No ]
- Safety profile [ Time Frame: Cycle 1 Day 1 through Follow-up ] [ Designated as safety issue: Yes ]
- Rate of adequate stem cell collection [ Time Frame: After completion of 3 cycle of treatment ] [ Designated as safety issue: No ]This will be assessed only for patients eligible for stem-cell transplantation after completion of R-Gemzar/Navelbine therapy
| Enrollment: | 0 |
| Study Start Date: | February 2009 |
| Study Completion Date: | October 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1 (eligible for SCT)
Patients receive rituximab IV, vinorelbine ditartrate IV over 6-10 minutes, and gemcitabine hydrochloride IV over 30 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) undergo SCT.
|
Biological: rituximab
Given IV
Drug: gemcitabine hydrochloride
Given IV
Drug: vinorelbine ditartrate
Given IV
|
|
Experimental: Group 2 (ineligible for SCT)
Patients receive rituximab, vinorelbine ditartrate, gemcitabine hydrochloride, and pegfilgrastim as in group 1. Patients with CR, PR, or stable disease after 3 courses continue to receive therapy in the absence of disease progression or unacceptable toxicity.
|
Biological: rituximab
Given IV
Drug: gemcitabine hydrochloride
Given IV
Drug: vinorelbine ditartrate
Given IV
|
Detailed Description:
OBJECTIVES:
Primary
- Assess the response rate (complete response/remission, unconfirmed complete response, partial response/remission) in patients with relapsed or refractory Hodgkin lymphoma treated with 3 courses of rituximab, gemcitabine hydrochloride, and vinorelbine ditartrate.
Secondary
- Assess progression-free survival, failure-free survival, and overall survival of patients treated with this regimen.
- Characterize the safety profile of this regimen in these patients.
- Determine the rate of adequate stem cell collection (≥ 2 million CD34+ cells) in patients eligible for stem cell transplantation.
OUTLINE: Patients are assigned to 1 of 2 treatment groups according to eligibility for stem cell transplantation (SCT).
- Group 1 (eligible for SCT): Patients receive rituximab IV, vinorelbine ditartrate IV over 6-10 minutes, and gemcitabine hydrochloride IV over 30 minutes on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) or partial response (PR) undergo SCT.
- Group 2 (ineligible for SCT): Patients receive rituximab, vinorelbine ditartrate, gemcitabine hydrochloride, and pegfilgrastim as in group 1. Patients with CR, PR, or stable disease after 3 courses continue to receive therapy in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed for at least 2 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
Pathologically confirmed classical Hodgkin lymphoma, including 1 of the following cell types:
- Nodular sclerosis
- Mixed cellularity
- Lymphocyte-rich
- Lymphocyte-depleted
- Measurable disease using the Cheson criteria, defined as ≥ 1 unidimensionally measurable lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
- Progressive or relapsed disease after ≥ 1 prior line of combination chemotherapy
- No known CNS metastasis
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- ANC > 1,500/mm^3
- Platelet count > 75,000/mm^3
- Total bilirubin ≤ 2 mg/dL (unless due to hemolysis)
- AST or ALT ≤ 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance ≥ 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No active hepatitis B infection
- No known chronic hepatitis B carrier
- No HIV positivity
No concurrent uncontrolled illness including, but not limited to, any of the following:
- Symptomatic neurological illness
- Active uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant at the time of study treatment
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Significant pulmonary disease or hypoxia
- Psychiatric illness or social situation that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 14 days since prior chemotherapy, immunotherapy, biological therapy, or investigational therapy and recovered
- No prior gemcitabine hydrochloride, vinorelbine ditartrate, or rituximab
- No other concurrent investigational or commercial agents or therapies with the intent to treat the malignancy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00881387
Locations
| United States, Florida | |
| University of Miami Sylvester Comprehensive Cancer Center - Miami | |
| Miami, Florida, United States, 33136 | |
Sponsors and Collaborators
University of Miami Sylvester Comprehensive Cancer Center
Investigators
| Study Chair: | Alexandra Stefanovic, MD | University of Miami Sylvester Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of Miami Sylvester Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00881387 History of Changes |
| Other Study ID Numbers: | EPROST-20080919, SCCC-2007092 |
| Study First Received: | April 14, 2009 |
| Last Updated: | February 18, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Miami Sylvester Comprehensive Cancer Center:
|
recurrent adult Hodgkin lymphoma adult lymphocyte depletion Hodgkin lymphoma adult lymphocyte predominant Hodgkin lymphoma adult mixed cellularity Hodgkin lymphoma adult nodular sclerosis Hodgkin lymphoma |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Gemcitabine Vinorelbine Rituximab Vinblastine Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 23, 2013