Expired Study
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Los Angeles, California 90095


Purpose:

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.


Study summary:

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.


Criteria:

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)


Study is Available At:


Original ID:

CDR0000067163


NCT ID:

NCT00003963


Secondary ID:

P30CA016042


Study Acronym:


Brief Title:

Chemotherapy and Monoclonal Antibody Therapy in Treating Patients With B-cell Non-Hodgkin's Lymphoma That Has Relapsed Following Peripheral Stem Cell


Official Title:

Treatment of B-Cell NHL Relapsing After Transplant With a Rituxan Vinorelbine Combination


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Jonsson Comprehensive Cancer Center


Oversight Authority:

  • United States: Federal Government
  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Intervention Model: Single Group Assignment, Maski


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

14


Enrollment Type:

Actual


Overall Contact Information

Official Name:Christos E. Emmanouilides, MD
Principal Investigator
Jonsson Comprehensive Cancer Center

Study Dates

Start Date:May 1999
Completion Date:February 2005
Completion Type:Actual
Primary Completion Date:September 2003
Primary Completion Type:Actual
Verification Date:July 2012
Last Changed Date:September 30, 2015
First Received Date:November 1, 1999

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Response rate
Time Frame:13 weeks
Safety Issues:False
Description:To preliminarily assess the response rates to such a regimen; to assess duration of response.
Outcome Type:Primary Outcome
Measure:Tolerability and toxicity
Time Frame:13 weeks
Safety Issues:True
Description: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.

Study Interventions

Intervention Type:Biological
Name:rituximab
Description: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.
Arm Name:Vinorelbine and Rituxan
Other Name:Rituxan
Intervention Type:Drug
Name:vinorelbine ditartrate
Description: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.
Arm Name:Vinorelbine and Rituxan
Other Name:Vinorelbine

Study Arms

Study Arm Type:Experimental
Arm Name:Vinorelbine and Rituxan
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Jonsson Comprehensive Cancer Center
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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