Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With B-cell Non-Hodgkin's Lymphoma That Has Relapsed Following Peripheral Stem Cell Transplantation
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| ClinicalTrials.gov Identifier: NCT00003963 |
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Recruitment Status :
Completed
First Posted : January 27, 2003
Last Update Posted : October 2, 2015
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RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of the monoclonal antibody rituximab plus chemotherapy with vinorelbine in treating patients with B-cell non-Hodgkin's lymphoma that has relapsed following autologous peripheral stem cell transplantation.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Biological: rituximab Drug: vinorelbine ditartrate | Phase 2 |
OBJECTIVES:
- Determine the tolerability and toxicity of rituximab combined with vinorelbine in patients with relapsed non-Hodgkin's lymphoma following autologous peripheral blood stem cell transplantation.
- Assess the response rate and duration of response to this regimen in these patients.
OUTLINE: Patients receive rituximab IV weekly on weeks 1-4, 6, 8, 10, and 12 and vinorelbine IV on weeks 2-4, 6-8, and 10-12. Patients who achieve partial response may continue on vinorelbine from week 14 until disease progression.
Patients are followed until disease progression.
PROJECTED ACCRUAL: A total of 18-25 patients will be accrued for this study.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 14 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Treatment of B-Cell NHL Relapsing After Transplant With a Rituxan Vinorelbine Combination |
| Study Start Date : | May 1999 |
| Actual Primary Completion Date : | September 2003 |
| Actual Study Completion Date : | February 2005 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Vinorelbine and Rituxan
Week 1-4: Rituxan is given at 375 mg/m2 weekly x4. Vinorelbine (25mg/m2) given 1 week after the first rituxan dose and immediately after the second rituxan dose. Week 5-8: Rituxan given every 2 weeks. Vinorelbine given weekly x3, with one week off. Week 9-12: Schedule same as week 5-8. Week 13 and following: If subject doesn't have disease progression, they may continue on Vinorelbine until progression or until clinically indicated. |
Biological: rituximab
Week 1-4: Rituxan is given at 375 mg/m2 weekly x4. Week 5-8: Rituxan given every 2 weeks. Week 9-12: Schedule same as week 5-8.
Other Name: Rituxan Drug: vinorelbine ditartrate Week 1-4: Vinorelbine (25mg/m2) given 1 week after the first rituxan dose and immediately after the second rituxan dose. Week 5-8: Vinorelbine given weekly x3, with one week off. Week 9-12: Schedule same as week 5-8. Week 13 and following: If subject doesn't have disease progression, they may continue on Vinorelbine until progression or until clinically indicated. Other Name: Vinorelbine |
- Tolerability and toxicity [ Time Frame: 13 weeks ]To define the tolerability and toxicity of a combination regimen of rituxan combined with vinorelbine for the treatment of B-cell NHL, relapsing after autologous stem cell transplantation.
- Response rate [ Time Frame: 13 weeks ]To preliminarily assess the response rates to such a regimen; to assess duration of response.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with B-cell Lymphoma, relapsing after high dose chemotherapy and autologous stem cell transplantation or allogeneneic stem cell or bone marrow transplant
- Age > 18 years old
- Adequate hematologic function, as manifested by ANC > 1000/mm3 and platelet count > 40,000/mm3
- PS WHO: < 3
Exclusion Criteria:
- Patients with serum creatinine > 2 mg%, transaminases (ALT, AST) > 3 times upper normal value, direct bilirubin > 2 mg%, unless they result from tumor involvement
- Pregnant or lactating females
- History of myelodysplastic syndrome
- Uncontrolled CNS disease
- Active serious infection
- History of refractoriness to vinorelbine. However, prior treatment with rituxan is not an exclusion (synergy may still occur)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003963
| United States, California | |
| Jonsson Comprehensive Cancer Center, UCLA | |
| Los Angeles, California, United States, 90095-1781 | |
| Principal Investigator: | Christos E. Emmanouilides, MD | Jonsson Comprehensive Cancer Center |
| Responsible Party: | Christos Emmanouilides, MD / Principal Investigator, UCLA |
| ClinicalTrials.gov Identifier: | NCT00003963 History of Changes |
| Other Study ID Numbers: |
CDR0000067163 P30CA016042 ( U.S. NIH Grant/Contract ) UCLA-9903029 NCI-G99-1545 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | October 2, 2015 |
| Last Verified: | July 2012 |
Keywords provided by Jonsson Comprehensive Cancer Center:
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Waldenstrom macroglobulinemia recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse large cell lymphoma recurrent adult immunoblastic large cell lymphoma |
recurrent adult lymphoblastic lymphoma recurrent adult Burkitt lymphoma recurrent mantle cell lymphoma recurrent marginal zone lymphoma recurrent small lymphocytic 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:
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Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Vinorelbine Rituximab Vinblastine |
Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |