Expired Study
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Los Angeles, California 90033


Purpose:

The current standard treatment for non-Hodgkin's lymphoma involves drugs called cyclophosphamide, doxorubicin, vincristine, prednisone and rituxan in a regimen called "R-CHOP." Using R-CHOP therapy, complete disappearance of disease is expected in over 50% of people. One of the active drugs in the R-CHOP regimen, doxorubicin, has previously been reformulated and been placed in a fatty bubble called a liposome. The reason for placing the drug in the liposome is that there is evidence that the liposome is better taken up by tumors. This liposomally encapsulated form of doxorubicin called Doxil has shown similar or better anti-tumor against certain tumors with reduced side effects. Doxil is FDA approved for ovarian cancer. However its use in non-Hodgkin's lymphoma is still investigational. By substituting Doxil for doxorubicin in the R-CHOP regimen, it is hoped this treatment will be better at shrinking tumors and with reduced side effects. The purpose of this study is to see how well the combination of Doxil, rituximab, cyclophosphamide, vincristine and prednisone (DR-COP) are in shrinking tumors in patients with non-Hodgkin's lymphoma.


Criteria:

Inclusion Criteria: - Pathologic diagnosis of Non-Hodgkin's lymphoma of B-cell origin: follicular large cell, diffuse large cell (including all B-cell variants), Burkitt or Burkitt-like lymphoma - All stages of disease - Measurable or evaluable tumor parameter(s) - Age greater than 17 years old - Karnofsky performance status greater or equal to 50% - AGC greater or equal to 1.0; platelets greater or equal to 75,000(unless abnormal because of lymphoma) - Bilirubin less or equal to 2.0; SGOT less or equal to 3 times upper limit of normal (unless abnormal because of lymphoma) - Creatinine less or equal to 2.0 or creatinine clearance greater or equal to 60 ml/min (unless abnormal because of lymphoma) - LVEF greater or equal to 45% - Concurrent RT with or without steroids for emergency conditions secondary to lymphoma (i.e., CNS tumor, cord compression)are permitted - Men and women of childbearing potential must agree to use adequate birth control for the duration of the therapy and for 3 months after completion of therapy - Signed informed consent Exclusion Criteria: - Prior systemic cytotoxic therapy or RT for lymphoma - Second active tumor, other than non-melanomatous skin ca and in-situ cervical cancer - HIV seropositive - Primary CNS lymphoma - Pregnant or nursing women - Unable to comply with the requirements of the protocol, or unable to provide adequate informed consent, in the opinion of the PI


Study is Available At:


Original ID:

13NHL-02-3


NCT ID:

NCT00184002


Secondary ID:


Study Acronym:


Brief Title:

Doxorubicin (Doxil) Combined With Rituxan, Cyclophosphamide, Vincristine and Prednisone in Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas


Official Title:

A Phase II Study Of Pegylated Liposomal Doxorubicin (Doxil) In Combination With Rituxan, Cyclophosphamide, Vincristine and Prednisone (DR-COP) In Newly Diagnosed Aggressive Non-Hodgkin's Lymphomas


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

N/A


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:

University of Southern California


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

68


Enrollment Type:

Actual


Overall Contact Information

Official Name:Anil Tulpule, MD
Principal Investigator
University of Southern California

Study Dates

Start Date:January 10, 2003
Completion Date:May 7, 2013
Completion Type:Actual
Primary Completion Date:December 19, 2012
Primary Completion Type:Actual
Verification Date:April 2017
Last Changed Date:April 8, 2017
First Received Date:September 12, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Number of patients with Adverse Events as a Measure of Safety and Tolerability
Time Frame:At end of every cycle
Safety Issues:False
Outcome Type:Primary Outcome
Measure:To determine the percentage of patients with complete response to the combination chemotherapy
Time Frame:At completion of cycle 4
Safety Issues:False
Description:Initial disease response tests will be performed after cycle 4 on all patients. Subsequent assessments after cycles 6 and/or 8 will depend on response.

Study Interventions

Intervention Type:Drug
Name:Doxorubicin, Rituxan, Cyclophosphamide, Vincristin
Description:Cycle 1 Doxil 40 mg/m2 iv day 1 over a minimum of 60 min. Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min. Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum). Prednisone 100 mg po days 1-5. Cycle 2 until study completion Doxil 40 mg/m2 iv day 1 Rituxan 375 mg/m2 iv day 1 Cyclophosphamide 750 mg/m2 iv day 1 Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) Prednisone 100 mg po days 1-5 1 cycle = 21 days. Continue treatment until 2 cycles beyond documentation of CR f
Arm Name:Arm I

Study Arms

Study Arm Type:Experimental
Arm Name:Arm I
Description:On cycle 1 patients receive Doxil 40 mg/m2 iv day 1 over a minimum of 60 min., Cyclophosphamide 750 mg/m2 iv day 1 over a minimum of 60 min., Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5. On cycle 2 until study completion patients receive Doxil 40 mg/m2 iv day 1, Rituxan 375 mg/m2 iv day 1, Cyclophosphamide 750 mg/m2 iv day 1, Vincristine 1.4 mg/m2 iv bolus day 1 (2.0 mg maximum) and Prednisone 100 mg po days 1-5 1 cycle = 21 days. Continue treatment

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Southern California
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Ortho Biotech, Inc.

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: November 18, 2019

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