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Biaxin Based Antibiotic Therapy in Previously Untreated, Advanced Stage Indolent Lymphoma

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ClinicalTrials.gov Identifier: NCT00461084
Recruitment Status : Completed
First Posted : April 17, 2007
Last Update Posted : September 18, 2014
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date April 13, 2007
First Posted Date April 17, 2007
Last Update Posted Date September 18, 2014
Study Start Date April 2007
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 10, 2007)
The primary objective of this study is to evaluate a biaxin (clarithromycin)-based antibiotic therapy in previously untreated patients with indolent lymphoma who do not require active lymphoma therapy (utilizing GELF criteria,). [ Time Frame: conclusion of study ]
Original Primary Outcome Measures
 (submitted: April 16, 2007)
  • The primary objective of this study is to evaluate a biaxin (clarithromycin)-based
  • antibiotic therapy in previously untreated patients with indolent lymphoma who do not
  • require active lymphoma therapy (utilizing GELF criteria,). This is the primary objective
  • Response rate (CR + PR) stratified for Follicular/Non-Follicular disease.
  • The secondary objectives of this study are to understand the biologic correlates of
  • indolent lymphoma biaxin (clarithromycin) response and progression:
Change History Complete list of historical versions of study NCT00461084 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 10, 2007)
The secondary objectives of this study are to understand the biologic correlates of indolent lymphoma biaxin (clarithromycin) response and progression [ Time Frame: conclusion of study ]
Original Secondary Outcome Measures
 (submitted: April 16, 2007)
  • The secondary objectives of this study are to understand the biologic correlates of
  • indolent lymphoma biaxin (clarithromycin) response and progression:
  • Response rate (CR + PR) according to H. pylori positive or negative (RR with a
  • confidence interval will be estimated for each subset).
  • Immunohistochemistry in all diagnostic biopsy specimens: Lymphocyte-
  • Activated Macrophage (CD68) and other selected markers to clarify tumor
  • infiltrating cells.
  • Peripheral blood mononuclear cell (PBMCs) studies to evaluate possible HDAC
  • (histone deacetylase) inhibition with biaxin (clarithromycin) therapy.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biaxin Based Antibiotic Therapy in Previously Untreated, Advanced Stage Indolent Lymphoma
Official Title Biaxin(Clarithromycin)Based Antibiotic Therapy In Previously Untreated, Advanced Stage Indolent Lymphoma
Brief Summary The purpose of this study is to see if a treatment with Biaxin (clarithromycin) which is an antibiotic given by mouth for 3 months can delay the growth of your lymphoma or shrink the lymphoma. We would also like to see how Biaxin (clarithromycin) works on lymphoma and blood cells.There is some evidence that this medication may change the behavior of lymphocytes, in addition to its known anti-infection activity.
Detailed Description

The primary objective of this study is to evaluate a biaxin (clarithromycin)-based antibiotic therapy in previously untreated patients with indolent lymphoma who do not require active lymphoma therapy (utilizing GELF criteria,). This is the primary objective Response rate (CR + PR) stratified for Follicular/Non-Follicular disease.

The secondary objectives of this study are to understand the biologic correlates of indolent lymphoma biaxin (clarithromycin) response and progression:

Response rate (CR + PR) according to H. pylori positive or negative (RR with a confidence interval will be estimated for each subset). Immunohistochemistry in all diagnostic biopsy specimens: Lymphocyte- Activated Macrophage (CD68) and other selected markers to clarify tumor infiltrating cells. Peripheral blood mononuclear cell (PBMCs) studies to evaluate possible HDAC (histone deacetylase) inhibition with biaxin (clarithromycin) therapy.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
tissue and whole blood
Sampling Method Non-Probability Sample
Study Population Previously Untreated follicular lymphoma or non-follicular lymphoma will be recrited at MSKCC
Condition Lymphoma
Intervention
  • Drug: BIAXIN (CLARITHROMYCIN)
    Biaxin (clarithromycin) 500 mg will be administered by mouth twice daily for 12 weeks in all patients. In H. pylori positive patients, Prevpak standard therapy (lansoprazole, amoxicillin, clarithromycin) will be administered for the first 2 weeks.Following Biaxin (clarithromycin) antibiotic therapy, the patient will be reassessed for eradication of H. pylori if previously present.
  • Drug: Biaxin (clarithromycin)
    Biaxin (clarithromycin) 500 mg will be administered by mouth twice daily for 12 weeks in all patients. In H. pylori positive patients, Prevpak standard therapy (lansoprazole, amoxicillin, clarithromycin) will be administered for the first 2 weeks.Following Biaxin (clarithromycin) antibiotic therapy, the patient will be reassessed for eradication of H. pylori if previously present.
Study Groups/Cohorts
  • 1
    lymphoma follicular
    Intervention: Drug: BIAXIN (CLARITHROMYCIN)
  • 2
    lymphoma non-follicular
    Intervention: Drug: Biaxin (clarithromycin)
Publications * Portlock CS, Hamlin PA, Gerecitano JF, Noy A, Palomba ML, Walkley J, Corcoran S, Migliacci J, Schoder H, Papanicolaou G, Markowitz AJ. A Positive Prospective Trial of Antibiotic Therapy in Advanced Stage, Non-Bulky Indolent Lymphoma. Tumor Microenviron Ther. 2015 Feb;2(1):14-18. Epub 2015 Feb 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 17, 2014)
36
Original Enrollment
 (submitted: April 16, 2007)
74
Actual Study Completion Date September 2014
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of follicular lymphoma: grades I, II, or IIIA, or non-follicular lymphoma: lymphoplasmacytoid lymphoma, small lymphocytic lymphoma, marginal B-cell lymphoma, or MALT lymphoma (as defined in the WHO classification1) as reviewed by a hematopathologist at Memorial Hospital.
  • Staging fulfills criteria for no initial treatment according to GELF criteria for advanced stage disease. None of the following should be present:

    • A nodal or extranodal mass with a diameter of >7 cm,
    • Involvement of at least three nodal sites [each with a diameter of >3 cm],
    • Systemic symptoms,
    • Symptomatic splenomegaly,
    • Ureteral compression.
    • No prior treatment for lymphoma is permitted.
    • Measurable disease is required.
    • Karnofsky performance status > 70%
    • The patient may not have a previous history of radiation therapy.
    • Patient or guardian must be able to sign voluntary written consent.
    • Male or female patients 18 years of age or greater.

Exclusion Criteria:

  • Allergy to biaxin (clarithromycin), erythromycin, or other macrolide antibiotic. Patients requiring use of ergot derivatives, pimozide, cisapride, or astemizole; combination with ranitidine bismuth citrate should not be used in patients with history of acute porphyria or CrCl <25 mL/minute.
  • Prior treatment with Biaxin (clarithromycin) during the prior 6 months.
  • Histologic diagnosis of follicular grade 3B or aggressive non-Hodgkin's lymphoma.
  • Histologic evidence of transformation from low grade/indolent NHL to aggressive NHL.
  • Prior treatment for non-Hodgkin's lymphoma.
  • Regional lymphoma (peripheral stages I and II) eligible for involved field irradiation.
  • GELF criteria21 for institution of systemic chemotherapy, which includes:

    • A nodal or extranodal mass with a diameter of >7 cm,
    • Involvement of at least three nodal sites [each with a diameter of >3 cm],
    • Systemic symptoms,
    • Symptomatic splenomegaly,
    • Ureteral compression.
  • Patients with a known history of HIV, Hepatitis B or C seropositivity.
  • Patients who require therapy with systemic corticosteroids.
  • Prior history of malignancy within the past five years or a concurrent malignancy, with the exceptions of cutaneous basal cell carcinoma or carcinoma in situ of the uterine cervix.
  • Pregnant or lactating women, since imaging cannot be done in this setting.18
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00461084
Other Study ID Numbers 07-038
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Carol Portlock, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date September 2014